Senior Director - Regulatory Affairs CMC

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 from leading workplace and culture organizations, including Science's Top Employers, Great Place To Work® in the U.S., and Fortune's Best Workplaces in BioPharma.

For patients, for each other, and for the future of science, we’re in. Are you?

About the Role:

We’re looking for a Senior Director, Regulatory Affairs CMC to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Regulatory Affairs CMC, the Senior Director will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries.

As a strategic function, RA CMC is required to collaborate closely with multiple functions within Insmed and with external CROs/CMOs. A successful candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends.

What You'll Do:

In this role, you’ll have the opportunity to plan, execute, and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with various teams.  You’ll also:

• Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug products worldwide with the flexibility for post-approval maintenance and lifecycle management of the marketed products.
• Perform due diligence assessment of potential drug products of small and large molecules.
• Develop plans for the preparation of CMC meetings with the regulatory agencies, and draft and review regulatory documents for CMC meetings with the agencies.
• Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings.
• Keep abreast of all pertinent regulations and guidance documents for pre- and post-approval submissions.
• Communicate regulatory CMC requirements to team members and advise of implications of the regulatory CMC strategies to CMC development plan and activities.
• Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formulation, manufacturing process, and device combination product development at various development stages and product lifecycles.
  

Who You Are:

You must have a Bachelor’s degree and 10+ years of pharmaceutical development and regulatory CMC experience supporting both small- and large-molecule products within multinational companies, including experience serving as a Regulatory Affairs CMC product lead.  Additionally, you have:

• Experience in the drug substance and drug product development of small and large molecules in terms of manufacturing process development and impurity controls.
• A solid understanding of US, EU, and Japanese regulations for drugs/biologics with the ability to identify the differences in regulations across the regions.
• Proven ability to liaise with Regulatory Agencies in agency interactions and product development meetings. 
• Knowledge of scientific principles and regulatory CMC requirements relevant to global drug development and post-market lifecycle support.
• Working knowledge of relevant FDA, EU, ICH, PMDA guidelines, initiatives and regulations governing CMC drug product development.
• Ability to deal with issues of critical importance, provide regulatory strategy/advice and make reasoned decisions on CMC regulatory issues for which they may not be clear or with specific regulatory guidance.
• Proven success with end-to-end project management within RA CMC or relevant experience.

• Strong communication skills with the ability to effectively present ideas and influence others to achieve desired results.  Ability to read and collate scientific and medical literature.
• Ability to lead others to move internal and external teams towards achieving goals that support Insmed’s key strategic objectives.
• Experience operating as a flexible and diplomatic individual; able to effectively deal with ambiguity, problem solve, and work effectively across functions as a team player.

Nice to Have (but not required):

• Advanced degree (MS, PhD, or PharmD) strongly preferred.

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.

Travel Requirements 

This position involves occasional domestic and/or international travel (approximately 10%).

#LI-Remote
#LI-MM

Pay Range:

$222,000.00-303,000.00 Annual

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.

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.

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [email protected].