Executive Director, Regulatory Affairs Strategist

Company Description

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.

Recognitions

 

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.

  

 

Overview

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.

Responsibilities

• 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 underst