New · posted Oct 15
Alnylam Pharmaceuticals · Biotechnology
Associate Director, Regulatory Affairs
- Cambridge, MA +1 more
- Hybrid
- Full-time
- Director
Open until filled
The role
The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data packages to the US FDA and other international health agencies (HA). The role is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration. The role is expected to serve as a USRegional Lead for for early programs in Alnylam pipeline. The role will guide regulatory strategy for the assigned programs and represent RA on multidisciplinary product development subteams and program Leadership Teams on those programs. Additional responsibilities include involvement in thewriting and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on regulatory requirements worldwide, and interpreting regulatory intelligence for the internal teams.
This is a hybrid role with onsite presence 2 days a week in either Cambridge, MA or Philadelphia, PA
The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
What you need
- Bachelor's degree with 6 or more years of experience in a Regulatory Affairs role; minimum of 8 years’ experience working in the biotech or pharmaceutical industry.
- Excellent written and verbal communication skills, including negotiation and influencing skills.
- Solid understanding of regulations and experience in interpretation of guidelines.
- Ability to think strategically and to proactively identify issues and mitigation strategies in various aspects of the drug development process.
- Experience with regulatory filings, including electronic submissions, e.g., INDs, CTAs, safety reporting, etc.
- Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.
- Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.
- Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.
What you'll do
Summary of Key Responsibilities
- Serve as US Regional Lead for assigned program, or as Regulatory Program Lead, leading the Global Regulatory Team, for one of the early programs in the Alnylam pipeline.
- Work with the Global Regulatory Lead and Regulatory Affairs management to lead and define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements and lead US HA interactions. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, Investigational New Drug (IND) applications, new Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Pediatric Plans, Orphan Designation and Expedited Pathway Applications (Breakthrough, Fast Track), and any amendments.
- Develop detailed regulatory project plans and support regulatory activities relating to specific portfolio of products/projects.
- Serve as member of the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.
- Participate as an active team member and provide strategic regulatory advice to project teams.
- Coordinate responses to regulatory authorities’ questions with strict adherence to deadlines.
- Serve as a liaison within internal departments at Alnylam, with CROs and with regulatory program managers at HAs.
- Maintain regulatory files in a format consistent with internal requirements.
- Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.
- Provide US specific regulatory intelligence to internal stakeholders as appropriate.
Pay and benefits
$170,900 – $231,300 a year
Employer providedMedical, dental, and vision coverage
Life and disability insurance
401(k) with company match
Paid time off and holidays
Annual bonus and equity eligibility
Family resources and leave
Where you'll work
Cambridge, MA +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Philadelphia, PA
More jobs in Cambridge, MA +1 more
From the posting
About Alnylam
We are the leader in RNAi therapeutics – a revolutionary approach 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 possible and 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, where an authentic, inclusive culture and breakthrough thinking fuel one another.
Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
U.S. Pay Range
$170,900—$231,300 USD
Equal opportunity, accessibility and legal noticesAlnylam Pharmaceuticals's statements, word for word
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 Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in Massachusetts27 roles publishing pay
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $170,900 | — | $231,300 |
| Massachusetts (middle half) | $207,500 | $232,500 | $264,500 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Alnylam Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Alnylam's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Regulatory submissions4
- Documentation and SOPs3
- GMP and compliance2
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Alnylam on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 3
- Locations
By discipline
- Regulatory3 43%
- Quality2 29%
- Compliance & Safety2 29%
By level
- Director4 57%
- Manager1 14%
- Senior & Principal1 14%
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Associate Director, Regulatory Affairs at Alnylam
Open until filled. $171K–$231K a year, employer provided.