New · posted Oct 15
Alnylam Pharmaceuticals · Biotechnology
Associate Director, Regulatory Affairs, CMC- Biologics
- Cambridge, MA +1 more
- Hybrid
- Full-time
- Director
Open until filled
The role
The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic modalities, with an emphasis on oligonucleotide-based therapeutics, including siRNA, antibody drug conjugates, and next-generation delivery systems.
This role serves as a key bridge between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences, helping to translate evolving science into effective global regulatory CMC strategies. The Associate Director will bring a broad scientific foundation in biologics and/or complex modalities, along with strong communication, collaboration, and project management skills. This individual will play an important role in evaluating the regulatory implications of novel technologies and guiding development teams through an evolving global regulatory landscape.
This position is hybrid and primarily located in our Cambridge, MA or Philadelphia, PA office.
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
- Advanced degree in chemistry, biochemistry, pharmaceutical sciences, molecular biology, or related discipline.
- Demonstrated experience supporting therapeutic products through multiple stages of development.
- Minimum 8-10 years of industry experience in the pharmaceutical/biotechnology industry, including at least 5 years of Regulatory Affairs CMC experience.
- Ability to interpret complex technical, nonclinical, clinical, and manufacturing information and translate it into clear regulatory strategies.
- Experience with regulatory submissions and health authority interactions for development-stage programs.
- Strong communication, collaboration, and cross-functional leadership skills.
- Ability to evaluate emerging technologies and apply sound regulatory judgment in a fast-paced, evolving environment.
- Strong ability to integrate scientific, technical, and regulatory considerations into clear actionable strategies.
Skills named in this posting
- Regulatory Affairs CMC (5+ years)
- 8-10 years pharma/biotech industry experience
- Global CMC regulatory strategy
- Regulatory submissions and health authority interactions
- Biologics and complex modalities (oligonucleotides, ADCs)
- Cross-functional leadership
- Advanced degree in chemistry, biochemistry or related science
- Regulatory intelligence
What you'll do
- Lead the development and execution of global CMC regulatory strategies for innovative small molecules, biologics, and complex modalities across early- and late-stage development.
- Plan, review, and prepare CMC documentation for clinical trial applications, marketing authorization applications, and health authority briefing packages.
- Lead or help to lead the interpretation of regulatory expectations for emerging modalities, including oligonucleotide therapeutics, conjugated delivery systems (e.g., GalNAc and other targeting ligands), antibody-drug conjugates, peptide conjugates, and biologic or hybrid modalities.
- Serve as a strategic interface between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences.
- Provide strategic guidance on product characterization, control strategies, comparability approaches, and regulatory classification considerations.
- Represent Regulatory Affairs CMC in cross-functional governance, development, and portfolio discussions.
- Partner with technical teams to identify regulatory risks and develop proactive mitigation strategies.
- Contribute to regulatory intelligence activities and interpretation of evolving policy for novel modalities.
- Help build Regulatory Affairs CMC infrastructure, processes, and organizational capability.
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, wellness days, and holidays
Annual short-term and long-term incentive awards
Flexible spending and health savings accounts
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 4% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in Massachusetts20 roles publishing pay
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $170,900 | — | $231,300 |
| Massachusetts (middle half) | $199,625 | $222,500 | $244,125 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: Alnylam Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Alnylam's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- Regulatory submissions2
- Documentation and SOPs1
- Regulatory Affairs CMC (5+ years)
- 8-10 years pharma/biotech industry experience
- Global CMC regulatory strategy
- Regulatory submissions and health authority interactions
- Biologics and complex modalities (oligonucleotides, ADCs)
- Cross-functional leadership
- Advanced degree in chemistry, biochemistry or related science
- Regulatory intelligence
Company 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, CMC- Biologics at Alnylam
Open until filled. $171K–$231K a year, employer provided.