Regulatory Strategy & Government Affairs Lead Job at Stedi

Federal Affairs Lead

Archer Aviation is hiring a Federal Affairs Lead to strengthen our efforts in sh...

Location

United States , Washington

Salary:

115000.00 - 154000.00 USD / Year

Archer Aviation

Expiration Date

Until further notice

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

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

Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

In this vital role you will support products in the Obesity Therapeutic Area. Gl...

Location

United States

Salary:

220356.00 - 269853.00 USD / Year

Amgen

Expiration Date

Until further notice

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

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

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

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

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

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

health and retirement, PTO, and stock option plans

Director, European Regulatory and R&D Policy

In this vital role you will be responsible for creating an optimal regulatory en...

Location

United Kingdom , Uxbridge; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree in public health, life sciences, public policy, business administration and/or law degree
Demonstrable experience in policy development, analysis and influencing
Demonstrable experience in successfully executing global regulatory policy strategies
Experienced solutions-orientated self-starter

Job Responsibility

Leading the development and execution of strategic plans for each assigned policy area
Ensure that Amgen’s regulatory, safety and R&D policy positions are successfully represented to inform policy development and implementation
Provide internal stakeholders with strategic regulatory policy perspectives
Guide and advise senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans
Support the creating of necessary infrastructure/processes for developing the regulatory policy function
Influence the development and articulation of Amgen’s position on regulatory policies that impact Amgen’s business
Represent Amgen in interactions with external regulatory, political, policy and professional organisations in a manner that aligns with the “one Amgen’ approach”

What we offer

Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Government Affairs Manager, DACH

Starship Technologies is seeking a strategic and driven Government Affairs Manag...

Location

Germany , Berlin

Salary:

Not provided

Starship Technologies

Expiration Date

Until further notice

Requirements

At least 5 years of experience in public/government affairs, policy, or regulatory affairs
A strong understanding of political systems across the DACH region
Expert knowledge of German legislative and political processes, with hands-on experience engaging with German Ministries, government bodies, and politicians
Experience collaborating with states, local authorities, or municipalities
Excellent communication skills in both German and English
other languages are a plus
Ability to work independently across multiple jurisdictions, while building strong relationships and staying adaptable and collaborative in fast-changing or ambiguous environments
Willingness and ability to travel within Germany regularly, and across the region as needed

Job Responsibility

Leading DACH government relations strategy across all levels of government, acting as the primary point of contact for policymakers, regulators, and public institutions
Developing and executing the public affairs strategy for the region, with an initial focus on Germany
Driving national regulation and legislation in the area of self-driving logistics
Monitoring and analyzing national legislation, local ordinances, and emerging policy trends in all DACH markets relevant to autonomous delivery, robotics, mobility, data use, and sustainability
Working closely with State and municipal governments, and local partners to secure permits, pilot programmes, and long-term deployments
Building relationships with third-party stakeholders such as accessibility groups, NGOs, think tanks, universities, and industry allies to strengthen the company’s position
Supporting commercial growth by enabling scalable policy frameworks and removing regulatory barriers to operation
Representing the company in key forums, events, trade associations, and public consultations
Collaborating with internal teams to align public affairs activities with commercial priorities and deployment roadmaps
Advising leadership on political risk, reputation, and emerging opportunities in the region

What we offer

You’ll be empowered to develop strategy and own implementation across your markets
You’ll have the chance to shape the policy landscape for a category-defining technology and make a tangible impact on sustainable urban mobility
Opportunity to work on industry-leading self-driving delivery robot technology on a uniquely large scale, creating history and making things happen
You will collaborate with highly motivated people who are passionate about what we do
We are a fast-growing company with great opportunities to grow within the company
Your contribution will matter
You’ll have endless opportunities to learn from our inspirational, talented team members across the globe
We work hard, but we have fun

Senior Regulatory Affairs Project Manager I, MILCON

ICON is seeking a highly motivated and dedicated Sr. Regulatory Affairs Project ...

Location

United States , Austin

Salary:

Not provided

ICON

Expiration Date

Until further notice

Requirements

Bachelor's degree in Structural Engineering, Civil Engineering, Architectural Engineering, or a related technical field
6+ years of relevant professional experience in structural engineering, construction, or regulatory affairs with demonstrated expertise in building code compliance
Strong understanding of building codes and standards, including UFC, IBC, IRC, ACI, ASCE, AISC, NDS, and TMS, with proven ability to interpret and apply complex regulatory requirements across federal and military jurisdictions
Demonstrated experience navigating federal regulatory approval processes with government agencies, which includes one or a combination of submission preparation, technical review coordination, and approval facilitation
Strong technical knowledge of structural systems and their integration with building enclosures, MEP systems, and construction methods for residential, commercial, and government buildings, with emphasis on concrete and masonry construction
Experience working with federal agencies, DoD organizations, or military construction projects with a general understanding of government contracting and acquisition processes
Understanding of structural testing methodologies and ability to develop test plans, analyze results, and prepare technical validation reports
Excellent verbal and written communication skills with proven ability to present complex technical information to government stakeholders, military officials, and internal teams
technical writing skills with ability to prepare code compliance documentation and regulatory submissions
Exceptional relationship-building and networking abilities with demonstrated success establishing trust and credibility with government agencies and federal stakeholders in professional and regulatory environments

Job Responsibility

Execute public sector regulatory efforts by aligning regulatory pathways with government building codes and standards. Accelerate adoption of concrete 3D-printed construction across federal and state agencies, DoD military construction (MILCON), and intelligence community customers
Build and maintain strong working relationships with federal technical groups —including USACE, NAVFAC, AFCEC, and other federal regulatory bodies—through presentations, and technical engagement
Support business development requests preparing technical proposals, delivering customer technical presentations, and technical demonstrations as needed
Serve as the primary regulatory contact for government projects and ICON customers working with federal agencies. Provide technical guidance, address regulatory questions, and resolve complex approval challenges
Lead regulatory acceptance and approval processes to incorporate ICON's technology into government building standards, including the Unified Facilities Criteria (UFC). Coordinate testing programs, manage agency interactions, and develop technical documentation that meets federal requirements
Coordinate regulatory testing and technology validation efforts required for federal market access. Ensure testing programs meet UFC requirements, support approval objectives, and align with project timelines
Conduct comprehensive federal code research and analysis to identify regulatory requirements, approval pathways, and potential barriers across UFC, federal building codes, and agency-specific standards. Synthesize findings to inform business development strategy
Collaborate with internal technical teams—including testing, materials science, product engineering, and operations—to integrate federal regulatory requirements into product development
ensure validation efforts support approval pathways and resolve technical challenges that impact government acceptance
Work with internal teams to resolve post-occupancy technical issues related to ICON's wall systems and building technology on government projects

Fulltime

New

Associate Director, Regulatory

We are seeking an experienced and highly motivated professional to join our team...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 8 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

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

health and retirement
PTO
stock option plans

Senior Director Regulatory Affairs

The Senior Director of Regulatory Affairs is responsible for assuring that all d...

Location

United States , Washington, DC

Salary:

137846.78 - 241870.90 USD / Year

Adtalem Global Education

Expiration Date

Until further notice

Requirements

Bachelor's Degree required, Master's Degree preferred
Minimum 10 years experience in a heavily regulated environment
preferably within post-secondary education required
Title IV compliance experience preferred
At least 5 years of supervisory experience
Must be familiar with the standards and requirements of the U.S. Department of Education, multiple state authorizing agencies and programmatic accreditors
Must possess strong critical thinking skills to decipher regulatory requirements that may not be explicit
Demonstrated ability to establish and develop positive relationships with senior leaders and external agencies
Strong interpersonal, organizational, writing, editing, and computer skills are required
Strong understanding of federal Title IV regulations

Job Responsibility

Leads and motivates the Regulatory Research, Compliance Review, Regulatory Strategy and Reporting teams of Regulatory Affairs colleagues
Collaborates with institution and business leaders, as well as peers in Regulatory Affairs, Internal Audit and Legal, to drive continual process and quality improvement
Monitors operations in all departments/functions to ensure compliance with federal and state/provincial higher education-related laws and regulations and organizational and divisional policies
Establishes working relationships with operating managers to assess the viability of their compliance functions, and educate operating units as to the essential components of a strong compliance program
Coordinates the compilation and synthesis of reporting for the quarterly Regulatory Compliance and Quality Assurance reviews with each of the institutions
Recommends business practice changes to improve compliance with higher education laws and regulations
Ensures that corrections in the areas of non-compliance are made timely and accurately
In coordination with the appropriate organization managers, reviews proposed process changes (including system requirements) to ensure they are in compliance with higher education-related federal and state/provincial laws and regulations and corporate and divisional requirements
Immediately reports areas of concern to the VP, Sr. Associate General Counsel and develops correction action plans and appropriate training requirements
Utilizing both internal and external resources, supports efforts to influence federal and state regulation development

What we offer

Health, dental, vision, life and disability insurance
401k Retirement Program + 6% employer match
Participation in Adtalem’s Flexible Time Off (FTO) Policy
12 Paid Holidays
Eligible to participate in an annual incentive program

Fulltime

Regulatory Strategy & Government Affairs Lead

Stedi

Location:
United States

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 18, 2026

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