Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

 

	Consistently Ranked Science’s Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

 

The Executive Director, Regulatory Affairs Strategist provides regulatory expertise and counsel on procedural and documentation requirements to Global Regulatory Teams (GRTs) and cross-functional teams working flexibly within and across regions to ensure delivery of business objectives.

• Drives the formulation of global regulatory strategy across the portfolio, from early to late stage, and post approval in collaboration with the Head of Regulatory Affairs and the Global Regulatory leadership team.
• Acts as a thought partner and enables the Head of Global Regulatory Affairs by providing quality regulatory input and strategic perspective to internal business partners, including research, clinical development, commercial, and medical teams.
• Provides perspective and is a trusted member of the Regulatory Leadership Team in the development, implementation, and regulatory management of individual programs.
• Interacts at the highest level with global regulatory agencies and ensures continuing robust relationships are in place.
• Liaises with clinical, commercial, and other internal colleagues in partnership with the GRL to enable successful regulatory outcomes.
• Contributes to the development of a harmonized, regulatory voice through participation in appropriate forums including communication to the company’s executive management team.
• Develops, implements, and maintains Global Regulatory Strategy documents for assigned programs using the support and input of cross-functional team and/or alliance partners where relevant.

Requirements:

• BS/BA in a relevant scientific field required; Advanced degree (PharmD, PhD, MD or DVM, or MS in Biology, Life Science, or related field) preferred.
• 12+ years of prior experience within the pharmaceutical/biotechnology industry, including at least 8 years of relevant Regulatory Affairs experience (regionally and/or global) especially in the development phase.
• Significant leadership experience with driving the preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, Health Authority meeting briefing documents, and negotiating with a national/regional Health Authority.
• Possesses a sophisticated understanding of the therapeutic area marketplace, clinical development of drugs, and/or innovative biologics products.
• Deep understanding of business priorities with strong leadership skills and adept at influencing and negotiating.
• Proven track record of balancing multiple intricate projects/deliverables simultaneously.
• Adept at using appropriate interpersonal styles and techniques to build internal and external networks and lead negotiations with customers.
• Self-motivated, proactive, and transparent working style, sharing diverse perspectives with relevant partners and multidisciplinary matrixed project teams (e.g. portfolio strategy team).
• Highly effective communication (oral, written, and presentation), time management, and operational skills.
• Proven experience working in, and solid understanding of, electronic document management systems to acquire and use regulatory deliverables (e.g., Veeva vault, Please Review, SharePoint).

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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.

 

 

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.