CrawlJobs Logo

Regulatory Strategy & Government Affairs Lead

United States · Job Posted February 18, 2026
Apply Position
Job Link Share

Job Description

We're hiring an experienced Regulatory Strategy & Government Affairs lead to work directly with our CEO, Head of Legal, and Network Operations team on a wide set of initiatives. Stedi's mission requires deep, reliable connectivity with healthcare payers. You'll lead the regulatory and operational efforts to establish and maintain those relationships, leveraging your knowledge of HIPAA transaction standards, CAQH CORE operating rules, and CMS requirements to broaden Stedi’s payer network. You'll also own a growing portfolio of payer, regulatory, and government affairs programs as Stedi's network and footprint expand.

Job Responsibility

  • Drive Stedi's regulatory affairs strategy by developing deep subject matter expertise and building relationships with payers, regulators and industry standards bodies
  • Quarterback compliance workstreams as we expand into new product areas
  • Own the end-to-end process for identifying, escalating, and resolving payer connectivity issues that implicate HIPAA, CAQH CORE, and/or CMS requirements
  • Conduct research on healthcare and financial services regulatory questions, monitor relevant legislation and rulemaking activity, and draft comment letters for agency proceedings
  • Draft outreach citing specific, relevant regulation that compels action, advocate for favorable regulatory interpretations, and maintain excellent relationships with payers
  • Work directly with world-class external counsel when necessary
  • Represent Stedi in discussions with payers, clearinghouses, and regulators, influence industry standards and operating rules

Requirements

  • 3+ years in health tech, fintech, compliance, government affairs, or a generalist in-house role
  • Excellent judgment and work ethic
  • Strong writing
  • Ability to pick up new subject matter quickly
  • Knowledge of HIPAA transaction standards, CAQH CORE operating rules, and CMS requirements
  • Ability to extract key information from complex regulatory documents and translate into business strategy
  • Thrive in ambiguity and create structure from chaos
  • Independently design scalable processes from scratch
  • Business acumen to blend legal rigor with strategic persuasion
  • Relentless, resourceful, and professional
  • Low ego, high throughput, and bias toward getting things done
  • Clear and confident communication with payers, regulators, government officials, and executives
  • Operate with clarity, accountability, and urgency

Nice to have

  • More senior candidates with broader experience
  • Experience in payments licensing, HIPAA transaction standards, or interoperability standards

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Regulatory Strategy & Government Affairs Lead

8 matching positions

Federal Affairs Lead

Archer Aviation is hiring a Federal Affairs Lead to strengthen our efforts in sh...
Location
Location
United States , Washington
Salary
Salary:
115000.00 - 154000.00 USD / Year
archer.com Logo
Archer Aviation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • At least 3 years of relevant policy, regulatory, or government affairs experience
  • Bachelor’s degree in public policy, political science, or related field (Hill experience is preferred)
  • Familiarity with federal transportation, aerospace, or emerging technology policy
  • Strong written and verbal communication
  • being able to explain technical concepts to non-technical audiences
  • Proven ability to build and maintain relationships with government official’s staff, stakeholders and advocacy organizations
  • Skilled at analyzing policy documents and making clear, actionable recommendations
Job Responsibility
Job Responsibility
  • Support Archer’s federal government affairs strategy to advance policies that enable the growth of the AAM industry
  • Build and maintain strong relationships with key Congressional offices, federal agencies, and industry associations to advocate for Archer’s priorities
  • Monitor and analyze policy and regulatory developments
  • provide timely insights and recommendations to internal teams
  • Represent Archer at relevant D.C. events, conferences, and member organization meetings, ensuring the company’s voice is influential in shaping the future of AAM
  • Develop clear and compelling presentations, briefings, and advocacy materials for policymakers and regulators
  • Collaborate with internal teams to align policy strategy with business objectives and foster a results driven environment
Read More
Arrow Right

Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

In this vital role you will support products in the Obesity Therapeutic Area. Gl...
Location
Location
United States
Salary
Salary:
220356.00 - 269853.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 5 years of regulatory experience in biotech or science
  • Master’s degree and 8 years of regulatory experience in biotech or science
  • Bachelor’s degree and 10 years of regulatory experience in biotech or science
Job Responsibility
Job Responsibility
  • To lead GRTs within Amgen’s GRAAS organization
  • To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
  • To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
  • Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
  • Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
  • Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
  • Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
  • Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
  • Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
  • Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment
What we offer
What we offer
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
  • Fulltime
Read More
Arrow Right

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...
Location
Location
United States , San Francisco Bay Area
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a scientific subject area coupled with sufficient industry experience
  • Advanced degrees (e.g. MSc, PhD, PharmD, MD) preferred
  • 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience
  • Experience in rare diseases, especially rare hematological disorders, preferred
  • Understands and works effectively with team members and consultants to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations
  • Ability to advise on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice
  • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
  • Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
  • Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally
Job Responsibility
Job Responsibility
  • Develop and execute innovative global regulatory strategies for global development of candidates for treatment of rare, hematological disorders
  • Define, develop, and lead execution of strategies to maximize global regulatory success and achieve program objectives for complex development projects in the rare disease space
  • Keep abreast of new developments in regulatory science and maintain oversight on evolving regulatory landscape and advancing innovations
  • Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
  • Contribute to cross-functional initiatives and influence the field
  • Represent Hemab in industry/regulatory forums to lead regulatory innovation
  • Responsible for complex and potentially multiple projects within the Rare Disease space
  • Development of regulatory strategies related to development and licensure of biologic development products
  • Represent Regulatory Affairs at project team meetings
  • Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions
  • Fulltime
Read More
Arrow Right

Director, Global Regulatory Lead – Obesity & Related Conditions (Chronic Weight)

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...
Location
Location
United States , Thousand Oaks
Salary
Salary:
195640.25 - 264689.75 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 4 years of regulatory experience
  • Master’s degree and 7 years of regulatory experience
  • Bachelor’s degree and 9 years of regulatory experience
  • 8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in chronic weight, obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas
  • Strong scientific literacy in metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and associated clinical endpoints
  • Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies
  • Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues
  • Proven ability to translate metabolic science into clear regulatory strategy and decision-making frameworks
  • Strong communication and negotiation skills, with the ability to guide teams through ambiguous or high-stakes situations
  • Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations is a plus
Job Responsibility
Job Responsibility
  • Develop and lead global regulatory strategy for obesity and metabolic disease programs, with specific focus on Chronic Weight, grounded in a strong understanding of metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science
  • Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations, accounting for regulatory precedent in obesity and related conditions
  • Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways
  • Advises on key clinical development elements relevant to obesity programs—study designs, chronic treatment safety, cardiovascular outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans
  • Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams
  • Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues to ensure seamless strategy execution
  • Translate complex metabolic science into actionable regulatory strategy for cross-functional partners, facilitating alignment on risk–benefit thinking and long-term labeling strategy
  • Oversee execution of major global regulatory submissions, including clinical trial applications, initial and supplemental marketing applications, pediatric plans, and labeling updates relevant to obesity programs
  • Ensure consistency, scientific rigor, and clarity across core regulatory documents—especially TPL, CDS, and briefing materials
  • Guides the regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions (where applicable)
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Global Regulatory Director Lead – Obesity & Related Conditions (Type II Diabetes)

The Director, Global Regulatory Lead (GRL) provides strategic regulatory leaders...
Location
Location
United States
Salary
Salary:
189632.45 - 256561.55 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 4 years of regulatory experience OR Master's degree and 7 years of regulatory experience OR Bachelor's degree and 9 years of regulatory experience
  • 8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in Type II diabetes, obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas
  • Strong scientific literacy in metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and associated clinical endpoints
  • Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies
  • Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues
  • Proven ability to translate metabolic science into clear regulatory strategy and decision-making frameworks
  • Strong communication and negotiation skills, with the ability to guide teams through ambiguous or high-stakes situations
  • Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations is a plus
Job Responsibility
Job Responsibility
  • Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes, grounded in a strong understanding of metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science
  • Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations, accounting for regulatory precedent in obesity and related conditions
  • Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways
  • Advises on key clinical development elements relevant to obesity programs—study designs, chronic treatment safety, cardiovascular outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans
  • Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams
  • Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues
  • Translate complex metabolic science into actionable regulatory strategy
  • Oversee execution of major global regulatory submissions
  • Ensure consistency, scientific rigor, and clarity across core regulatory documents
  • Guides the regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions
What we offer
What we offer
  • Health and welfare plans for staff and eligible dependents
  • Financial plans with opportunities to save towards retirement or other goals
  • Work/life balance
  • Career development opportunities
  • Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in life sciences or related field required (advanced degree preferred)
  • Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
  • Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
  • Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
  • Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
  • Excellent communication, negotiation, and leadership skills
  • Strong team orientation and passion for continuous self-development
Job Responsibility
Job Responsibility
  • Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
  • Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
  • Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
  • Assess and communicate potential regulatory risks and propose mitigation plans
  • Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
  • Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
  • Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
  • Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
  • Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
  • Coordinate and prepare responses to requests for information from regulatory agencies
What we offer
What we offer
  • health and retirement, PTO, and stock option plans
Read More
Arrow Right

External Public Affairs Manager

The External Public Affairs Lead will manage the organisation’s public policy, l...
Location
Location
United Kingdom
Salary
Salary:
Not provided
campdenbri.co.uk Logo
Campden BRI
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree qualified in public policy, law, political science, economics, international relations, or a relevant scientific/regulatory discipline
  • A postgraduate qualification (e.g., Masters) in a relevant field is an advantage
  • Extensive experience 5 yrs + working in government affairs, public policy, regulatory strategy, or a related senior‑level external affairs role, ideally within the food, drink, science, or consumer goods sectors
  • Demonstrated credibility when engaging with senior government officials, regulators, policy advisers, and industry bodies, with a strong understanding of UK and EU policy‑making processes
  • Strong capability to interpret, analyse and communicate complex legislation, regulatory developments, and political trends
  • Experience developing policy positions, consultation responses, strategic briefings, and evidence-based advocacy materials
  • Skilled at developing and executing advocacy strategies that influence government policy and regulatory frameworks
  • Strong stakeholder management skills with the ability to build trusted relationships across government, industry, members/clients, and internal teams
  • Proven ability to lead multi-stakeholder projects, influence outcomes, and navigate political and regulatory environments
  • Effective project and programme management experience, including coordination of cross-functional teams
Job Responsibility
Job Responsibility
  • Lead the development and implementation of the organisation’s government affairs strategy, ensuring alignment with business priorities and industry needs
  • Monitor, assess and communicate emerging legislation, policy reforms and regulatory developments across UK, EU, and global markets
  • Advise senior leadership on risks, opportunities, and the strategic implications of policy trends
  • Build and maintain influential relationships with government departments, regulatory authorities, parliamentarians, policy advisers, and public sector stakeholders
  • Represent the organisation externally, positioning it as a trusted expert voice in food, drink, and consumer goods policy
  • Participate in consultations, policy reviews, advisory groups, and public hearings
  • Oversee political monitoring processes and ensure timely, accurate intelligence flows into the organisation
  • Prepare regular reports, risk analyses, and strategic updates for senior leadership teams
  • Support training and capability‑building across the business on policy engagement and government interface
  • Develop some evidence-based advocacy materials, including position papers, briefings, consultation responses, and speeches
What we offer
What we offer
  • Reward platform with employee discounts and rewards
  • 25 days holiday + 8 bank holidays
  • Buy and sell holiday scheme
  • A generous work save pension scheme, with employee contributions matched by the company up to 10%
  • Culture focus around work/life balance (early finish Fridays)
  • Subsidised onsite restaurant
  • Fulltime
Read More
Arrow Right

Service Line Lead – NAM Regulatory Development & Sciences

ProductLife Group is a global consulting and outsourcing partner to the life sci...
Location
Location
United States
Salary
Salary:
200000.00 - 260000.00 USD / Year
productlifegroup.com Logo
Product Life Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a scientific discipline (life sciences, pharmacy, biology, chemistry, or related field)
  • Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred
  • 20+ years of experience in regulatory affairs within the biotechnology and/or pharmaceutical industry
  • Demonstrated experience leading regulatory strategy and execution across early- and late-stage development through marketing authorization
  • Proven leadership experience in a consulting, professional services, or matrixed delivery environment
  • Extensive experience interacting with U.S. and ex‑U.S. Health Authorities and interpreting global regulatory frameworks
  • Deep expertise in global regulatory requirements, guidance, and legislation applicable to drug and biologic development
  • Ability to translate regulatory requirements into practical, executable development and submission strategies
  • Advanced understanding of regulatory submission strategy, Health Authority engagement, and regulatory risk management
  • Strong financial and operational acumen, including KPI management, forecasting, budgets, and utilization within consulting environments.
Job Responsibility
Job Responsibility
  • Own end-to-end performance and delivery of the Regulatory Development & Sciences Service Line
  • Drive service line KPIs including quality, timeliness, utilization, revenue, margin, and client satisfaction
  • Ensure consistent application of global standards, methodologies, SOPs, and quality requirements across all engagements
  • Act as senior escalation point for clients, balancing delivery quality, commercial objectives, and client expectations
  • Lead development and execution of global regulatory strategies across all stages of development, from pre‑IND to post‑marketing
  • Act as senior regulatory SME for complex and high‑impact programs
  • Serve as on‑demand Head / VP / Director of Regulatory Affairs for client organizations
  • Lead Health Authority interactions, including acting as Authorized Sponsor Representative when required
  • Provide strategic oversight and hands-on input into Health Authority meeting packages, special designation requests, and major regulatory submissions
  • Own financial and commercial management of the Service Line, including forecasting, budgeting, revenue planning, margin protection, and utilization
  • Fulltime
Read More
Arrow Right