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Sr Director

2 months ago

lexington, United States The Newsome Group Full time

The Executive Director will be responsible for developing and implementing global regulatory strategy leading to successful registration and life-cycle management.

This individual will provide regulatory leadership to cross-functional teams responsible for global programs and ensure effective communication with business partners and representatives of the US Food and Drug Administration/EMA and other Health Authorities worldwide.

This role is based in Lexington, MA and requires 4 days per week onsite.

Relocation Assistance not available.


Responsibilities:

  • Provide regulatory strategic leadership for drug development projects and life cycle management (LCM), including but not limited, to regulatory submissions to EMA and other Health Authorities worldwide, health authority interactions, and other regulatory requirements in line with corporate objectives and timelines
  • Serve as an influential and well-respected spokesperson with staff at FDA/EMA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of original applications and supplements
  • Provide de-risking development strategies and evaluating opportunities to accelerate development in a fast-paced environment
  • Provide leadership, and contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA/EMA and other Health Authorities worldwide in support of INDs, BLAs, MAAs, DMFs, CTRs/CTAs, IMPDs, PIPs, PAERs, amendments, safety reports, and annual updates
  • Interpret and communicate regulatory expectations to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations


Qualifications:

  • Requires a minimum of 10 years of experience in Regulatory Affairs within the bio pharmaceutical industry
  • Master’s Degree required
  • PharmD or PhD preferred
  • Strong knowledge of FDA and EU regulations
  • Prior experience with FDA and EMA required, and success with filing BLAs/NDAs/MAAs desired.
  • Experience with both early and late-stage drug development desired
  • Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities
  • Experience required with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages, pediatric study plans and documents for other regulatory submissions
  • Experience interacting directly with the FDA/EMA and other health authorities desired
  • Experience with biologics drug development is desirable; experience in immunology/inflammation is a plus
  • Familiar with eCTD, e-publishing systems for preparing regulatory submissions a plus
  • Strategic thinker who can balance near term objectives with long term goals and outcomes
  • Ability to thrive in a collaborative and fast-paced team environment
  • Ability to travel up to 10%