Associate Director, Regulatory Affairs (CMC)

Compensation

$164,000.00 - $164,000.00 / Yearly

Hours Per Week

40

Number Of Positions

1

Job Description

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?

About 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.

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.

Who You Are:

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.

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

Minimal travel expected

Pay Range:

$164,000.00-213,000.00 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.

Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjM2NDcyLjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t

Place of Work

On-site

Requisition ID

R3641-3486