Note: The job is a remote job and is open to candidates in USA. Alnylam Pharmaceuticals is a leader in RNAi therapeutics, dedicated to transforming the lives of individuals with rare and common diseases. They are seeking a Senior Legal Director, R&D and Regulatory Counsel who will provide strategic legal guidance on regulatory pathways and product development, while collaborating with cross-functional teams to manage legal and regulatory risks.
Responsibilities
- Provide clear, practical legal counsel to R&D and Regulatory colleagues on novel or complex matters involving U.S. and global regulatory pathways, product classification, exclusivity, and lifecycle strategy, and support critical submissions and health authority interactions
- Partner with the Public Policy & Government Relations team to influence advocacy strategy and policy engagement, including contributions to trade associations and regulatory reform initiatives
- Advise Quality, Safety, Pipeline Delivery, and Legal colleagues on GCP compliance and related risk areas, including fraud prevention, product liability, privacy, pharmacovigilance, inspection readiness, and human subject research protections
- Serve as a trusted legal advisor to Quality in assessing and investigating allegations, managing inspections, and ensuring compliance with legal and regulatory reporting requirements
- Monitor and interpret evolving legislation, policy, industry standards, and enforcement trends affecting lifecycle management, and provide actionable guidance to stakeholders and leadership on resulting risks and opportunities
- Provide strategic legal support for complex research contracts, including drafting, reviewing, interpreting, and negotiating collaboration, sponsored research, and data and material transfer agreements
- Collaborate across Legal and cross-functional partners to design integrated legal solutions that enable pipeline delivery, clinical trial execution, and portfolio growth
- Support the development of scalable policies, processes, templates, tools, and governance that advance Alnylam’s mission to deliver transformative medicines to patients
Skills
- JD from an ABA-accredited law school and admission in good standing to at least one U.S. jurisdiction
- Minimum of 12 years of post-JD experience advising on legal matters in the life sciences industry, including significant FDA regulatory law experience gained through law firm practice focused on FDA and regulatory matters or relevant government service, such as at the FDA
- Deep expertise in U.S. regulatory frameworks, with working knowledge of EMA processes preferred
- Demonstrated experience advising on complex regulatory strategy and novel modalities
- Demonstrated experience advising cross-functional teams on clinical research, drug development, regulatory submissions, GCP, and related compliance frameworks, including regulatory exclusivities, orphan drug designations, as well as privacy, fraud and abuse, and product liability laws
- Strategic thinker who translates complex regulations into pragmatic, risk-based business guidance
- Strong executive presence and proven influence with senior stakeholders in a matrixed organization
- Exceptional judgment, collaboration, and interpersonal communication skills
- Maintains an independent, objective perspective while building strong partnerships with colleagues
- Thrives in ambiguous, high‑stakes environments
- Works independently, manages multiple matters, and delivers high-quality work under tight timelines
- High integrity, forward-looking perspective, and a solution-oriented approach
- Advanced contracting and redlining skills, with strong attention to detail
- Ability to manage outside counsel effectively and efficiently while adhering to budget expectations
- Working knowledge of EMA processes
Benefits
- Eligible for an annual short-term incentive award (e.g., bonus or sales incentive)
- Eligible for an annual long-term incentive award (e.g., equity)
- Comprehensive benefits including medical, dental, and vision coverage
- Life and disability insurance
- A lifestyle reimbursement program
- Flexible spending and health savings accounts
- 401(k)with a generous company match
- Paid time off
- Wellness days
- Holidays
- Two company-wide recharge breaks
- Generous family resources and leave
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