Associate Director, Regulatory Affairs - Bridgewater Township

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, cel ...

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 – Advertising and Promotion to help us expand what's possible for patients with serious diseases.

Reporting to the Executive Director, Regulatory Ad Promo & Intelligence Initiatives, the Associate Director will review and approve advertising and promotional materials, related training, and other nonproduct commercial communications, medical materials, and publications.

Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new and updated regulations and guidance documents for both labeling and promotion.

The Associate Director, Regulatory Affairs – Advertising and Promotion will also coordinate training pertaining to advertising, promotion, and product launch activities.

The individual will work collaboratively with medical affairs, legal, compliance, and commercial teams in the development and implementation of advertising and promotional processes and materials for product portfolio.

What You'll Do

In this role, you'll have the opportunity to represent Regulatory Affairs as part of cross-functional commercial review committee, providing regulatory input into the review and approval of promotional and nonpromotional materials


You'll also:

Maintain a deep and current awareness of evolving US regulations, codes and guidelines, enforcement actions, and policy issues affecting the pharmaceutical/biotech industry as it pertains to labeling and promotion.

Represent Regulatory Affairs as a reviewer on medical review committee providing regulatory input on materials that include clinical trial recruitment efforts and field medical resources.

Provide regulatory review on publications and own responsibility for ensuring compliance with regulatory agencies' requirements.
Provide strategic regulatory advice for labeling, taking into consideration marketing use post-approval.
Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management.
Coordinate regulatory training on regulatory issues pertaining to advertisement and promotion activities.

Who You Are

You must have at least a Bachelor's degree in a relevant/scientific discipline and 7+ years' experience working in the pharmaceutical or biotech industry


Additionally, you have:
5+ years working in the advertising and promotional review space.
Experience working with OPDP and with post market FDA submissions.

Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion.

Knowledge of US regulations for labeling.

Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence all business functions to reach resolution.

Strong writing, project management, and communication skills.
Proven ability to thrive in a fast-paced environment.
Strategic problem solver with strong collaboration skills.

Nice To Have (but Not Required)

Graduate degree preferred.
Awareness of global drug/biologic regulations and standards particularly related to promotion including EU and international requirements.

Where You'll Work

This can be a fully remote role because the selected candidate should be able to perform effectively from anywhere while staying connected to your Insmed team and community.

Occasional travel for team meetings or events will be expected.

Alternatively, if you live within a drivable distance of our Bridgewater, NJ facilities, you'll have the option to work remotely most of the time, but with more in-person collaboration when it matters most.

Travel Requirements

This role requires domestic travel (up to 25%).

Pay Range

$164, ,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.

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 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.