Senior Director, Regulatory Affairs Job at Beam Therapeutics (Cambridge)

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

Director Regulatory Affairs

The Director is a senior people leader responsible for the operational effective...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree, 15+ years of experience in CMC and/or Device regulatory, and 8 years of leadership experience
Master’s degree and 17+ years of experience in CMC and/or Device regulatory, and 10 years of leadership experience
Bachelor’s degree, 20+ years of experience in CMC and/or Device regulatory, and 15 years of leadership experience

Job Responsibility

Provide inclusive, inspiring leadership for staff within the CMC & Device Regulatory team in AIN
Attract, hire, develop, and retain top regulatory talent
foster a culture of learning, engagement, inclusion, and high performance
Ensure staff receive appropriate onboarding, development, and ongoing support
Promote behaviors and ways of working consistent with Amgen’s values and leadership attributes
Oversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancements
Partner closely with functional and regulatory leadership to drive strategic alignment across Amgen’s products
Ensure high-quality, timely, and compliant regulatory deliverables
Build and maintain strong partnerships with global functional leaders and internal stakeholders
Serve as a trusted and proactive cross-functional partner

System Director, Regulatory Affairs and Accreditation

The System Regulatory Director is responsible for oversite and operations of the...

Location

United States , Charleston

Salary:

Not provided

MUSC Health

Expiration Date

Until further notice

Requirements

Bachelor's Degree or Equivalent
9 years progressive work experience
4 years management experience

Job Responsibility

Directs one or more major functional areas of a department, a department, or a business unit
Manages two or more professional and support staff including subordinate managers
Directs the analysis, planning, implementation, and expenditures and budget tracking of major operational projects or initiatives
Provides recommendations to the leaders throughout the organization
Leads in developing strategies and implementation plans to improve and standardize all aspects of operations
Collaborates with department/business unit leadership to support the budget process and meeting key operational goals
Collaborates with leaders to establish operating procedures, enhance clinical and non-clinical workflows, increase productivity, and improve overall quality outcomes and operational efficiencies within a variety of delivery settings
Establishes department policies and procedures
Serves as the primary liaison for the department
Manages and influences relationships with senior management team, administrators, functional area managers and staff to achieve best in practice performance and business results

Fulltime

Director, Regulatory Affairs – Americas & ANZ

As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory...

Location

United States

Salary:

154000.00 - 230000.00 USD / Year

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent
advanced/regulatory certification (e.g., RAC) highly desirable
Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM)
At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders
Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments
Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives
Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners)
Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage
Willingness to travel across Americas region
flexible to address regulatory or business needs globally as required

Job Responsibility

Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions
Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal
Lead strategic high-complexity/ high-risk regulatory projects
Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function
Oversee the preparation & submission of regulatory filings (including both product & facility licensing/registration) within Americas for all class and type of Products
Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate
Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs
propose harmonization initiatives for labeling, documentation, submission processes across region
Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls)
Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands

What we offer

comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
Flexible Time Off (FTO), receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members

Fulltime

Senior Regulatory Affairs Project Manager I

ICON is seeking a highly motivated and dedicated Project Manager to work at the ...

Location

United States , Austin

Salary:

Not provided

ICON

Expiration Date

Until further notice

Requirements

Graduate degree in Civil Engineering, Structural Engineering, or a related technical discipline
8+ years of relevant professional experience in structural design, testing, research, or construction with demonstrated project management responsibilities
Demonstrated experience managing multiple concurrent complex technical projects, including schedule development, budget management, and stakeholder coordination
Proven ability to work with and manage external consultants, laboratories, and vendors while maintaining quality standards and project deliverables
Strong understanding of structural engineering from first principles, including mechanics of materials, structural analysis, and design fundamentals
Practical experience in the design and testing of concrete and masonry structural systems and materials
Hands-on experience with structural testing equipment, including hydraulic cylinders, pumps, actuators, load frames, instrumentation, and data acquisition systems
Advanced problem-solving abilities and analytical thinking skills to assess complex technical challenges and develop effective solutions across multiple disciplines
Strong technical writing and communication skills with demonstrated ability to prepare comprehensive reports and present findings to diverse stakeholder groups
Familiarity with applicable structural testing standards, ACs, and codes, including ASTM, ACI, ASCE, and building code requirements

Job Responsibility

Develop and manage project schedules, cost estimates, and budgets for complex testing campaigns while tracking progress against milestones and managing scope changes
Direct and oversee comprehensive test plan development and specimen design that meets structural testing objectives and regulatory requirements for ICON's 3D printed systems
Develop and oversee the generation of detailed engineering documentation for print processes such as technical drawings, instructions, and logs, directing team members and consultants as needed
Coordinate with internal ICON departments including Testing, Hardware, and Operations teams to ensure testing is successfully completed while communicating project progress, blockers, and results to key stakeholders
Manage and oversee contracts with third-party laboratories, consultants, and vendors conducting advanced analysis, research, development, or manufacturing for ICON to ensure successful execution of the regulatory program goals and objectives. Including but not limited to testing logistics, shipping, proposal evaluation, cost negotiation, schedule coordination, performance oversight, and deliverable management
Participate in testing observations and coordinate with external stakeholders to gather real-time data while directing project teams and resolving scheduling conflicts
Conduct and oversee the analysis and interpretation of test results using advanced analytical techniques, guiding consultants and team members in identifying performance trends and developing design methodologies
Provide regular updates on project progress to the Regulatory Affairs Program Manager, and Director of Building + Construction Science
Support regulatory approval processes by directing established testing approaches, guiding development of new methodologies, and overseeing preparation of comprehensive technical documentation for regulatory bodies in accordance with the project schedule and budget

Fulltime

Senior Director, Government Affairs

In the role of Senior Director, Government Affairs you will serve as Microsoft's...

Location

United States , Washington D.C.

Salary:

160700.00 - 284400.00 USD / Year

Microsoft Corporation

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Public Policy, Public Administration, Political Science, Business Administration, Technology, Law, Liberal Arts, Engineering, or related field AND 8+ years work experience in government affairs, corporate affairs, public policy, government, or related area
OR equivalent experience

Job Responsibility

U.S. AI Policy Strategy & Frontier Governance: Leads Microsoft's U.S. AI policy strategy across government, industry, and third parties in Washington, DC
Develops and executes Microsoft's approach to U.S. AI policy in close collaboration with ORA, Standards and Security teams, including federal legislation, national standards, and federal–state alignment, ensuring coherence across governance, innovation, and deployment priorities
Helps shape Microsoft's federal policy positions on emerging and high-stakes frontier AI policy questions, including agentic systems, recursive self-improvement, model access and security, and evaluation frameworks
Translates technical and policy developments into actionable strategy: Converts fast-moving legislative, regulatory, and technical developments into clear guidance, decision-ready materials, and strategic recommendations for senior leadership—ensuring alignment with Microsoft's product, research, and security priorities
Drives technically grounded coalition and ecosystem engagement: Leads engagement with policymakers, peer companies, civil society, and thought leaders in Washington to advance credible, evidence-based AI policy outcomes, with an emphasis on building durable consensus and reinforcing Microsoft's role as a trusted, technically informed voice
Leads cross-functional integration of AI policy across priority domains: Partners across USGA and CELA to integrate AI policy into broader agendas, including national security, workforce and labor, science and research policy, and global competitiveness—ensuring consistency with Microsoft's end-to-end AI strategy
Physical AI, Robotics, and Autonomous Systems Policy: Builds Microsoft's federal policy agenda for physical AI: Co-develops and advances Microsoft's U.S. policy strategy on physical AI, including robotics, autonomous systems, embodied AI, and industrial AI—establishing this domain as a core and forward-looking pillar of the company's AI policy work
Translates technical innovation into policy leadership: Serves as the convener and collaborator between ORA, Microsoft Research, the Office of the Chief Science Officer, and product teams, distilling cutting-edge R&D into clear policy positions and legislative frameworks for U.S. policymakers
Leads early-stage policymaker engagement and thought leadership: Builds and maintains relationships across the White House, Congress, and key agencies (e.g., DOC, DOD, DOE, NIST) to shape emerging U.S. approaches to physical AI and position Microsoft as a trusted leader in safe and responsible deployment
Integrates physical AI into broader AI and industrial policy frameworks: Ensures alignment of robotics and embodied AI policy with Microsoft's broader positions on AI governance, workforce transformation, supply chains, infrastructure, and national competitiveness—reflecting the convergence of digital and physical systems

Fulltime

Senior Director, Corporate Affairs, CV Communications

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

Location

United States , Thousand Oaks

Salary:

198606.75 - 268703.25 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of communications or public relations experience
Master's degree and 9 years of communications or public relations experience
Bachelor's degree and 11 years of communications or public relations experience
5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
15 or more years of experience in communications, public relations, corporate affairs, or related fields
Deep understanding of the biotechnology, pharmaceutical, or healthcare industry paired with significant experience in cardiovascular disease communications
Demonstrated ability to develop and execute integrated communications strategies tied to clear business objectives, priority audiences, insights, KPIs, and measurable outcomes
Strong understanding of data, analytics, social listening, media intelligence, stakeholder insights, and measurement as core inputs to modern communications strategy
Practical experience using AI, digital platforms, analytics, and emerging technology to improve communications strategy, execution, efficiency, measurement, and impact
Strong executive presence and experience counseling senior leaders on business-critical communications opportunities and challenges

Job Responsibility

Lead global and U.S. communications for Amgen's cardiovascular portfolio, ensuring strategies are integrated, business-relevant, and aligned across key internal partners
Serve as a senior communications advisor and point of accountability to global and U.S. cardiovascular leadership teams
Develop and execute integrated communications strategies that support business objectives, strengthen Amgen's cardiovascular story, and engage priority audiences across global and U.S. channels
Lead communications for marketed products, future launch readiness activities, and stakeholder-facing campaigns
Partner across Corporate Affairs, including Advocacy, Enterprise Media, Internal Communications, Digital and Social, Policy Communications, and other key functions, as well as Investor Relations, Medical Affairs, Legal, Regulatory, Commercial, Government Affairs, and Value & Access, to deliver integrated strategies
Translate scientific, clinical, and business information into clear, credible, audience-relevant communications for patients, healthcare professionals, media, advocacy partners, internal audiences, and other stakeholders
Successfully use data, analytics, social listening, audience insights, and measurement to inform strategy, optimize execution, and demonstrate impact
Identify opportunities to responsibly use AI, digital tools, and emerging technology to improve planning, content development, stakeholder engagement, workflow efficiency, and measurement
Inspire and manage a high-performing team by setting clear priorities, supporting development, strengthening ways of working, and maintaining high standards
Anticipate and navigate emerging issues, new information, stakeholder dynamics, and rapid changes in the external environment

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

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

Select Country

Senior Director, Regulatory Affairs

Job Description

Job Responsibility

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