Director, Regulatory Affairs, Global Labeling Strategy (US)

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 200,000 - 300,000; Full time

Job summary

Alnylam Pharmaceuticals seeks a Director of Regulatory Affairs, Global Labeling Strategy (US) to lead the US labeling function within the Global Labeling team. The role shapes CCDS, CPI, and TLPs, guiding evidence plans and negotiation pathways for multiple regions.

You will influence study design, evidence elements, and health authority interactions across disciplines. Ideally, you bring 12+ years in biopharma regulatory affairs with strong labeling experience, strategic judgment, and

Qualifications

• BS/BA degree (science or related discipline preferred)
• Minimum of 12 years in biopharma Regulatory Affairs, Pharmacovigilance, or Medical Writing/Communications
• Minimum of 7–8 years in Regulatory Affairs with at least 5 years in labeling strategy
• Thorough knowledge of US, EU and Global labeling regulations and guidance
• Ability to connect target claims to study design, endpoints, and evidence
• Experience with leading cross-functional teams and influencing senior stakeholders
• Familiarity with AI-enabled research tools, source verification, and regulatory judgment
• Strong drafting, negotiation, and communication skills
• Ability to stay current on regulatory developments affecting labeling

Responsibilities

• Lead US Labeling within Global Labeling, building scalable capabilities
• Interpret data and craft labeling strategies across regions
• Develop and maintain CCDS, CPI, and Target Label Profiles
• Partner with Clinical Development, Biostatistics, Medical, Safety, Regulatory, and Market Access
• Influence study design, endpoints, and evidence required for labeling
• Synthesize regulatory intelligence, literature, and competitor analysis
• Lead scenario-based claim strategies and negotiation plans
• Represent Global Labeling in governance forums and cross-functional teams
• Oversee preparation of labeling materials and health authority responses
• Mentor and grow the Regulatory Labeling Strategy team
• Coordinate labeling activities with internal and external partners
• Support systems and process design for global labeling

Skills

Regulatory strategy

Labeling strategy

GxP knowledge

Cross-functional leadership

AI-enabled research

Project management

Negotiation

Technical writing

Strategic thinking

Education

Bachelor’s degree in life sciences

Graduate degree desirable

Tools

CCDS

Target Label Profiles

Job description

Director, Regulatory Affairs, Global Labeling Strategy (US)

Overview

The Director of Global Labeling (GL) US will play a lead role in building and refining Alnylam's global labeling strategy processes and capabilities; supervise junior labeling strategists and provide strategic guidance in the development and maintenance of Company Core Data Sheets (CCDS), country product information (CPI) for Alnylam's products, and development of Target Label Profiles (TLP) for investigational therapies or uses.

Summary of Key Responsibilities

• Lead Alnylam's US Labeling function whilst forming part of the Global Labeling team in Regulatory Affairs, and build new, scalable capabilities and processes to support Alnylam's growth as a commercial organization.
• Strong scientific background in different disease areas working across multiple therapy areas, with a focus on the interpretation of data and the strategic implications for labeling.
• Ensure the implementation of differentiated global labeling strategies and Target Label Profiles that articulate the intended product value, priority claims, evidence requirements, risks, and negotiation pathways.
• Translate strategic labeling ambitions into actionable evidence plans by partnering early with Clinical Development, Biostatistics, Medical, Safety, Regulatory, and Market Access teams.
• Influence study design and endpoint selection by identifying the primary, secondary, exploratory, patient-relevant, and other evidence elements required to support compelling and defensible labeling claims.
• Drive and implement novel labeling options by synthesizing regulatory precedents, competitor positioning, health authority decisions, scientific literature, clinical practice, and evolving policy. Precedent analysis is an input, not the endpoint.
• Use approved AI tools and advanced research approaches responsibly to accelerate intelligence gathering, identify patterns and evidence gaps, stress-test strategic options, and improve the quality and speed of labeling recommendations. Apply expert review, source verification, confidentiality controls, and regulatory judgment to all AI-supported outputs.
• Lead the development of scenario-based claim strategies, including ambitious, target, and fallback positions, with clear evidence thresholds, trade-offs, and negotiation plans for key regions.
• Represent Global Labeling (GL) including US Labeling on Regulatory Affairs governance forums and other cross-functional product, development, and product safety teams as appropriate.
• Develop and provide strategic guidance on emerging labeling regulations, health authority expectations, competitor labels, labeling trends, and implications for the development portfolio and marketed products.
• Lead regional labeling development aligned with the CCDS and tailored to health authority requirements, local evidence expectations, and the global negotiation strategy.
• Lead and oversee preparation of labeling briefing materials and responses to health authority questions, and support negotiations with robust evidence-based arguments and well-developed fallback positions.
• Coordinate labeling activities with internal and external alliance partners and align stakeholders around strategic objectives, decision points, and accountabilities.
• Partner with Labeling Operations, Regulatory Technology and Operations, and Supply Chain to ensure submission-ready labeling components comply with regulatory requirements. Assist with preparation of submissions to health authorities, as needed.
• Effectively plan for, hire, on-board, and mentor Regulatory Labeling Strategy team as company grows.
• Support the growth of the Global Labeling function and help design/build systems and processes.

Qualifications

• BS/BA degree (science or related discipline preferred), graduate degree desirable.
• Minimum of 12 years of professional experience in biopharmaceutical industry in fields of Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
• Minimum of 7-8 years of experience in Regulatory Affairs, including at least 5 years of experience in labeling strategy.
• Thorough knowledge of US, EU and Global regulations, standards and guidance documents related to labeling of pharmaceutical products.
• Demonstrated ability to create and gain approval for labeling strategies that connect the target claim to study design, endpoint selection, analysis, and the evidence package.
• Strong strategic judgment and creativity: able to move beyond describing precedents to formulate new, credible, and differentiated approaches.
• Ability to synthetize regulatory intelligence, literature research, competitor analysis, and data to generate actionable recommendations.
• Curiosity and practical experience with AI-enabled research and productivity tools, combined with disciplined source verification, protection of confidential information, and accountable human oversight.
• Track record of influencing cross-functional teams, constructively challenging assumptions, and communicating strategic choices to senior stakeholders.
• Excellent drafting, facilitation, negotiation, and written and verbal communication skills.
• Highly organized and detail-oriented, with the ability to manage multiple complex programs and balance strategic ambition with executional rigor.
• Highly motivated to work independently and represent the position of Global labeling.
• Ability to remain current on emerging clinical and safety data, manufacturing changes, post-marketing commitments, and regulatory developments that may affect the CCDS or regional and local labeling.
• Track record in developing and maintaining Target Label Profiles, Company Core Data Sheets, Standard Operating Procedures (SOPs) and Work Instructions, and managing or coordinating core labeling activities.
• Prior experience managing a team desirable.

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About Alnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

Before applying, please review Alnylam's CandidatePrivacy Noticeregarding how Alnylam handles Personal Data you provide with your application for employment.