New · posted Oct 15
Insmed · Pharmaceuticals
Associate Director, Regulatory Affairs (CMC)
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
We’re looking for an Associate Director, Regulatory Affairs CMC on the Regulatory Affairs CMC team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Regulatory Affairs CMC, EMEA, you’ll have responsibility for leading CMC regulatory strategy development and implementation that incorporates risk identification and mitigation for assigned development and post approval programs to achieve regulatory approvals in the EMEA region.
At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.
For patients, for each other, and for the future of science, we’re in. Are you?
Where You’ll Work
This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.
What you need
You have a minimum of a Bachelor's degree along with 5-7 years of pharmaceutical development and regulatory CMC experience in the biotechnology or pharmaceutical industry. Biologics and inhalation drug product development knowledge in EMEA region is desirable. You are or also have:
Prior experience within a GMP environment with a firm understanding of industry regulations and best practices.
A solid understanding of EU/ICH regulations and other country specific guidelines for small molecules and/or biologics.
Knowledge of global regulatory guidance documents and regulations with emphasis on the interrelationship between CMC and all other development. functions (for example, clinical supplies, qualification of impurities via toxicology testing, etc) as related to the overall global regulatory strategy.
Understanding and interpretation of complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
Travel Requirements
Minimal travel expected
What you'll do
In this role, you’ll have the opportunity to plan and coordinate regulatory submissions to support projects in development and commercial applications, including lifecycle management of products in the EMEA region.
You’ll also:
Work closely with cross-functional teams to ensure short and long term objectives are achieved in a proactive and time efficient manner.
Lead the development of CMC background documentation for consultation with the EMA, MHRA and other regulatory authorities.
Identify key CMC content requirements and author the CMC sections for IND/IMPD, NDA/MAA, and other regulatory submissions based upon internal technical documents provided by Tech Operations or from vendor supplied documents to support clinical studies and product registrations, ensuring they meet current regulatory standards and are of high quality, consistent, and complete.
Establish product specific strategies to ensure successful development of CMC submission packages to support early development, registration and life cycle management.
Have accountability for reviewing and approving all CMC change control documents and disposition of proposed changes relating to products in the EMEA region, scheduling submissions as necessary based on such changes.
Provide interpretation of applicable EMA/ICH/WHO, and other country specific regulations to ensure the compliance of CMC content within regulatory filings.
Keep abreast of all pertinent regulations and guidance documents for pre and post approval submissions.
Pay and benefits
$164,000 – $213,000 a year
Employer provided$164,000.00-213,000.00 Annual
Medical, dental, and vision coverage
Generous paid time off
401(k) with company match
Annual equity awards and ESPP
Company-paid life and disability insurance
Learning Institute and mentorship programs
From the posting
About Insmed
Life at Insmed
At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
Current Insmed Employees: Please apply via the Jobs Hub in Workday.
Equal opportunity, accessibility and legal noticesInsmed's statements, word for word
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $164,000 | — | $213,000 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: Insmed'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 Insmed'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.
- Regulatory submissions7
- GMP and compliance5
- Documentation and SOPs5
- Collaboration and leadership4
- Lab testing and methods1
- Validation and qualification1
- Quality systems and risk1
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.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- 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
Company hiring pulse
Insmed on Regulatory Jobs
- 13
- Open roles
- 13
- Distinct roles
- 3
- Locations
By discipline
- Quality8 62%
- Regulatory4 31%
- Compliance & Safety1 8%
By level
- Director7 54%
- Associate & Specialist3 23%
- Manager2 15%
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Associate Director, Regulatory Affairs (CMC) at Insmed
Open until filled. $164K–$213K a year, employer provided.