Regulatory Affairs Director

7 days ago


Massachusetts, United States Mantell Associates Full time
{"title": "Senior Director of Regulatory Affairs (EU)", "description": "

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm that partners with biopharmaceutical companies to discover, develop, and deliver life-changing therapies for people with serious diseases.

This role is responsible for developing and implementing the EU regulatory strategy and plan for assigned clinical and/or pipeline programs.

Key Responsibilities:

  • Define European regulatory strategy and plan to maximize regulatory success
  • Provide strategic and operational input to program teams to achieve program objectives while ensuring compliance with applicable regulatory requirements
  • Develop regulatory roadmaps to inform and guide agency engagement strategies; partner with key stakeholders to develop and implement comprehensive regulatory engagement plans
  • Serve as point of contact with EMA, leading and managing regulatory interactions, building trusted relationships with regulatory authorities
  • Lead cross-functional efforts to ensure timely submission of key regulatory documents
  • Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success
  • Identify regulatory risks and opportunities and work with key stakeholders to develop solutions
  • Provide regulatory input and support for business development activities
  • Partner with global market access and medical affairs colleagues to support interactions with joint regulatory/health agency/HTA bodies on product-specific value evidence topics, as applicable
  • Ensure strong representation of regulatory voice at key governance bodies and teams
  • Maintain currency of EU regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance
  • Monitor and analyze global and country-specific regulatory landscapes to assess potential impact on programs; collaborate with teams to ensure compliance
  • Provide support to local regulatory experts
  • Provide regulatory support for cross-functional activities as needed

Requirements:

  • Education in life sciences required
  • 7+ years of experience in the biopharmaceutical industry with deep understanding of EU regulatory requirements
  • Demonstrated experience of leading successful engagement with EMA
  • Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred but not required
  • Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
  • Strong written, verbal communication skills, and interpersonal skills
  • Capable of managing shifting priorities in a rapidly changing environment
  • Ability to travel domestically and internationally (10%)

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +1 (786) 485 1298.

", "lang_code": "en"}

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