Title: Senior Director/Vice President Regulatory Affairs

Location: Waltham, MA

This role is the senior regulatory strategist supporting our early to late phase clinical assets.  You will be responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of products.  You will provide regulatory leadership through cross functional collaboration, the development, planning and execution of regulatory strategy to facilitate achievement of the company’s short and long-term objectives.  You will also be responsible for global programs ensuring effective communication with representatives of the FDA and global health authorities.

Primary Responsibilities

  • Provide regulatory oversight and guidance to project teams on compliance matters, health authority requirements, clinical study design issues, logistics and operational recommendations for product development
  • Accountable for the development and submission of regulatory documents (e.g., pre-IND and end of phase briefing books, INDs, NDA/BLAs, CTAs, MAAs, responses to regulatory inquiries, IND Safety reports, etc.)
  • Facilitate problem-solving and drive decision making regarding regulatory, preclinical, clinical, CMC development issues with project teams
  • Work pro-actively to partner with other functions to plan and execute an effective regulatory strategy in alignment with the overall clinical plan
  •  Ongoing management of the regulatory strategy including effectively communicating deliverables to project team and proactively drive teams and external partners to meet the designated timelines for deliverables
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the project teams and Executive Leadership team as required
  • Establishes and maintains excellent relationships with regulatory agency personnel.  Responds to request for additional data, organizes and manages participation in meetings, and prepares internal teams for these interactions. Negotiates directly with regulatory authorities regarding company filings
  • Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact

Knowledge and Skill Requirements

  • Bachelor’s degree in a scientific discipline; PharmD or PhD preferred
  • Minimum 10 years in life sciences industry related experience with experience in Regulatory strategy
  • Experience in Pharmacovigilance required; QA experience is preferred
  • Knowledge of the current US and EU regulations
  • Experience with CTD format and content regulatory filings
  • Demonstrated track record in securing product approvals and maintaining a complex portfolio
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development product registration, line extension and license maintenance in the EU and the US
  • Experience managing complex schedules and priorities in dynamic environments; ability to conform with shifting priorities, demands and timelines through analytical and problem-solving capabilities
  • Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners
  • Familiar with e-publishing systems for preparing regulatory submission a plus

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