Director of Regulatory Affairs Job at Life Science Talent (Cambridge)

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...

Location

United States , New York

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

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.

Job Responsibility

Will be responsible for complex and potentially multiple projects within the Rare Disease space. Responsible for development of regulatory strategies related to development and licensure of biologic development products. Represents Regulatory Affairs at project team meetings.
Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions to deliver on the proposed strategy with the project teams.
Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that may impact regulatory success. Communications demonstrate sound judgement and are provided in a professional and timely manner.
Responsible for proactively anticipating regulatory risks and for developing mitigation strategies in alignment with team and management
understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed.
The Director will be accountable for all Regulatory Agency submissions and approvals of project(s) of responsibility, overseeing outsourced vendors and/or Hemab internal team members.
Direct point of contact with health authorities, leads and manages Regulatory Agency meetings, in cooperation with outsourced vendors.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
Participates in or leads departmental and cross-functional taskforces and initiatives.
Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.

Fulltime

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...

Location

United States , San Francisco Bay Area

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

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

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

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...

Location

Sweden , Greater Malmö Metropolitan Area

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific subject area coupled with sufficient industry experience
8+ years of pharmaceutical industry experience
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
Understands and interprets scientific data as it relates to regulatory requirements and 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

Job Responsibility

Develop and execute innovative global regulatory strategies for the global development of candidates for the 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
Keep abreast of new developments in regulatory science and maintain oversight on the evolving regulatory landscape and advancing innovations
Understand and interpret scientific data as it relates to regulatory requirements and strategy
Represent Regulatory Affairs at project team meetings
Collaborate across technical functions to create innovative regulatory strategies and pragmatic solutions
Effectively communicate regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders
Proactively anticipate regulatory risks and develop mitigation strategies
Be accountable for all Regulatory Agency submissions and approvals, overseeing outsourced vendors and/or internal team members
Be the direct point of contact with health authorities, lead and manage Regulatory Agency meetings

Fulltime

Executive Director of Regulatory Affairs - Obesity and Related Conditions

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Thousand Oaks

Salary:

255302.00 - 345408.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 6 years of regulatory affairs experience OR Master's degree & 10 years of regulatory affairs experience OR Bachelor's degree & 12 years of regulatory affairs experience AND 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Lead, coach, and mentor staff to develop a high-performing regulatory organization grounded in continuous learning, with a strong focus on talent development, leadership capability, and a succession planning culture
Build strong alignment across global and regional teams ensuring clarity of purpose, priorities and coordinated execution
Guide integrated cross-indication regulatory strategy across Obesity programs, ensuring alignment of development pathways, evidence generation, and global registration approaches
Provide strategic regulatory expertise and guidance to therapeutic area commercialization teams and other governance bodies
Act as a trusted strategic partner to Global Regulatory Leaders (GRLs) providing guidance on complex regulatory decisions, risk management, and long-term strategy
Conduct management review and approval of Global Regulatory Strategic Plans
Conduct review and approval of key documents for regulatory submissions
Anticipate and translate the evolving regulatory landscape within therapeutic area into forward looking regulatory strategies and opportunities
Work externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area
Oversee and participate in licensing/acquisition due diligence and other activities in partnership with Amgen licensing groups

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 where possible

Fulltime

Director of Regulatory Affairs and Public Policy

Rowan Digital Infrastructure is looking for a Senior Director of Regulatory Affa...

Location

United States , Denver

Salary:

170000.00 - 210000.00 USD / Year

Rowan Digital Infrastructure

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a related field and 10+ years of public policy experience within government and/or relevant nonprofits, public interest groups, business, campaigns or industry associations
Demonstrated ability to persuasively and diplomatically advocate policy positions publicly before key stakeholders on behalf of industry
Demonstrated track record of success in developing strong partnerships with AHJs, economic development organizations, state and local government, and other key stakeholders
Experience leading corporate understanding of the U.S. energy market and regulatory environment
regulatory experience, business development, and/or commercial experience is preferred
Previous positions within renewable energy generation, storage, transmission, or electricity policy would be a strong asset
Core understanding of policies and regulations unique to specific markets and across multiple disciplines, transmission planning and cost allocation, interconnection, market rules and reliable operations
Experience communicating with senior leaders and executives at all levels of the organization
Deep experience leading advocacy on evolving policy impacting data center/energy industry preferred
The ideal candidate will have a passion for energy and environmental policy

Job Responsibility

Represent Rowan at various public events and effectively communicate the benefits of Rowan project investments to external key stakeholders
Drive strategic engagement with trade associations, manage consultants and other relevant third parties as needed to meet Rowan objectives
Identify and track pertinent legislation and policy proposals that may have business implications on Rowan’s operations
Support Economic Development, Development, and Energy SMEs to navigate evolving policy landscape in key markets to both unlock and protect key states of interest for Rowan
Lead analysis of regulatory and policy developments impacting Rowan’s investments, including energy, tax, AI, air permitting, and other data center related matters
Proactively establish, maintain and grow key relationships with decision makers and stakeholders in PUCs, RTO/ISO and other pertinent forums
Support Rowan’s energy team with identification, analysis and assessment of regulatory and market affairs issues, devise proactive engagement strategies to best position the Rowan portfolio for success
Communicate regularly and effectively in a cross-functional manner with Rowan energy, site origination, site development, finance, and other pertinent teams to translate regulatory and market issues into business impacts and opportunities to benefit Rowan’s portfolio

What we offer

Hybrid working environment
Team building and educational opportunities
Generous benefits package including robust health benefits and a 401(k) company contribution
Unlimited PTO
Competitive compensation and bonus plan

Fulltime

Director of Policy and Regulatory Affairs

XYPN is the only turnkey advice and planning platform that makes it possible for...

Location

United States , Bozeman

Salary:

100000.00 - 142000.00 USD / Year

XY Planning Network

Expiration Date

Until further notice

Requirements

5+ years of relevant experience in public policy, regulatory affairs, government relations, securities regulation, or financial services advocacy, including experience tracking, analyzing, and responding to state and/or federal regulatory developments
Proven ability to independently analyze and summarize complex securities legislation and regulatory proposals
Excellent written communication skills with experience drafting white papers, policy briefs, and comment letters
Familiarity with administrative rulemaking processes, public comment procedures, regulatory hearings, and policy engagement strategies
Strong understanding of the securities and financial services regulatory framework governing investment advisers
Strong relationship management, with the ability to build credibility across regulators, members, and industry partners
Comfort operating both strategically and operationally, from shaping advocacy priorities to executing day-to-day policy work
Strong track record of managing high-stakes policy issues and building relationships with financial regulators at the state and federal level
Legally authorized to live and work in the United States without present or future need for sponsorship

Job Responsibility

Monitor for relevant regulatory developments across all 50 states and the SEC, ensuring timely awareness of new compliance issues, rule proposals, and comment periods
Develop and maintain XYPN’s advocacy and policy roadmap, including issue tracking, prioritization, engagement status, and next steps
Partner with the Managing Director and Executive Team to shape advocacy priorities and provide informed recommendations on engagement opportunities
Develop a deep understanding of XYPN member firms, industry trends, and emerging regulatory issues to inform advocacy priorities and identify opportunities to influence regulation
Develop consistent channels for gathering member feedback, case studies, and practical examples to inform XYPN’s advocacy positions
Coordinate member-facing communications regarding advocacy initiatives, regulatory updates, and policy resources
Partner with members to prepare for legislative or regulatory hearings, meetings with state regulators and legislators, and other advocacy opportunities, including testimony and supporting materials
Develop and deliver educational sessions for legislators, regulators, XYPN members, and industry groups on regulatory trends, RIA business models, operational realities, and the impact of proposed regulation
Build productive relationships with regulators, industry stakeholders, advocacy partners, and member firms to support ongoing dialogue and collaboration
Coordinate strategic partnerships with industry associations, including IAA, FPA, NAPFA, CFP Board, and other aligned organizations

What we offer

100%- employer-funded Employee Stock Ownership Plan (ESOP)
Unlimited vacation days (minimum of 3 weeks per year)
9 paid holidays (flexible holidays)
401(k) with match (you put in 6%, we put in 4.5%)
12 weeks paid parental leave
Health insurance w/ employer contribution
Dental, Vision, Voluntary Life and AD&D, and Accident insurance options
Pet insurance availability
Health Savings & Flex Spending Accounts available
Employer-paid Life and AD&D insurance

Fulltime

Director of Quality and Regulatory Affairs

The Director of Quality and Regulatory Affairs leads the global QA/RA function a...

Location

United States , Burlington

Salary:

170000.00 - 180000.00 USD / Year

Myomo

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific, technical, or related discipline
advanced degree preferred
8-10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry, including significant management experience
5+ years of experience with Class I and/or Class II medical devices
Experience operating within FDA-regulated cGMP environments, including regulatory submissions and agency interactions
Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971, and Design Controls
Experience managing Quality Management Systems (QMS) for medical devices
Experience supporting global regulatory activities (e.g., EU, Canada, APAC preferred)
Demonstrated experience leading QA/RA teams, including talent development and performance management
RAC certification or equivalent is preferred

Job Responsibility

Lead the global QA/RA function and is responsible for execution of the company’s quality and regulatory strategy
Ensure compliance with applicable global regulations and standards (including FDA and ISO requirements) and oversees quality systems across the product lifecycle
Partner cross-functionally to support product development, regulatory submissions, and ongoing compliance activities, while driving continuous improvement in quality processes
Contribute to the development and lead execution of the Quality strategy
Lead departmental planning and budgeting, optimizing resources and operational efficiency
Direct QA/RA staff, including organizational design, talent development and performance management
Develop and continuously improve quality programs, policies, and processes
Ensure Quality Management System (QMS) processes are established, implemented, and maintained
Lead regulatory activities and compliance interactions, serving as the primary liaison with regulatory authorities
Oversee development and execution of global regulatory strategies for product submissions and lifecycle management

Fulltime

Director Regulatory Affairs

As Director Regulatory Affairs you will report to the Chief Regulatory Affairs O...

Location

Sweden , Lund

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Education in the natural sciences space with an MSc degree in Pharmacy, Chemistry or similar
Ideally 10+ years’ experience in industry and 7+ years in Regulatory Affairs
Experience in preparing regulatory strategies/regulatory development plans, highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments
Experience with clinical trial submissions and approvals
Previous experience in a senior regulatory role, including health authority interactions, e.g. FDA and EMA meetings is required, and experience with BLA/MAA dossier preparation and submissions is desirable
In-depth understanding of regulations and guidelines governing all phases of drug development
Highly resourceful team-player, with the ability to be also extremely effective independently
Strategic mindset, innovative yet pragmatic/solution-oriented thinking, at the same time keen to also work in an operational role with attention to detail
Strong written and oral communication skills
comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities.

Job Responsibility

Lead and contribute to regulatory strategies for assigned projects that expedite development, maximize the probability of success and mitigate risks
Play a hands-on role in planning, preparing and coordinating regulatory documents for submission to global health authorities as part of regulatory filings, such as CTAs/INDs, amendments, annual updates, paediatric investigation plans, orphan drug applications, fast track applications, responses to health authority information requests and BLAs/MAAs
Managing and leading the planning and preparation of meeting requests and meeting packages for health authority interactions for assigned projects
Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards
Provide regulatory leadership and guidance to cross-functional project teams and lead the development, strategy and execution of regulatory submission documents while working collaboratively with the project team including a variety of personnel and staff
Liase with internal QA and CMC teams ensuring regulatory requirements are consistently met across QA and manufacturing functions.

Fulltime

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