Director Regulatory Affairs, Tactical Implementation

Regulatory Affairs Lead

The Regulatory Affairs Lead for the Tactical Implementation Team will lead the regulatory team responsible for the execution of regulatory activities across assigned programs and markets. This role ensures timely and compliant preparation, submission, and maintenance of regulatory filings throughout the product lifecycle, including regulatory writing. The Lead serves as a key interface between strategic regulatory leadership and cross-functional stakeholders to ensure successful delivery of regulatory objectives.

Responsibilities

• Lead and develop a team responsible for the tactical execution of global regulatory submissions (e.g., INDs/CTAs, NDAs/BLAs, MAAs, variations, amendments, annual reports).
• Collaborate with strategic regulatory leads in translating regulatory strategy into actionable plans and deliverables.
• Manage preparation and medical writing of regulatory documents and meeting briefing materials
• Oversee submission planning, preparation, quality control, and tracking in alignment with project timelines and regulatory requirements.
• In collaboration with regulatory strategists, act as regulatory point of contact for cross-functional teams to ensure seamless operational execution of regulatory submissions.
• Provide oversight into the preparation and review of high-quality regulatory documents and ensure accuracy, consistency, and adherence to agency expectations.
• Monitor regulatory intelligence and guidance relevant to operational execution; ensure internal processes and deliverables remain aligned with current regulations.
• Contribute to the development and continuous improvement of regulatory systems, tools, templates, and procedures to enhance submission quality and efficiency.
• Represent the Tactical Implementation Team in internal governance, regulatory planning, and operational working groups.

Position Requirements (Required and/or Preferred Skills, Experience and Education)

• Bachelor’s degree in life sciences or related field; advanced degree (MS, PhD, PharmD) preferred.
• Minimum of 8 years of experience in Regulatory Affairs, including hands-on experience with regulatory submissions in multiple regions (US, EU, and/or other international markets).
• Strong understanding of global regulatory requirements and submission formats (eCTD).
• Demonstrated experience managing complex regulatory deliverables across product lifecycle stages.
• Excellent project management, communication, and organizational skills.
• Proven ability to work collaboratively across cross-functional teams and in a matrix environment.
• Prior experience in people or project team leadership is highly desirable.

• Travel (approximately 15%) may be required

Insmed is an Equal Opportunity Employer

Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

Salary Range

$179,000 - $250,800 a year

Compensation & Benefits

At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

For more information on U.S. benefits click here.

Additional Information

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.

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 TotalRewards@insmed.com 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.