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Director/Sr. Director, Regulatory Affairs

Cambridge, MA

Posted: 10/07/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2451

Reporting to the Senior Vice President of Regulatory Affairs, the successful candidate will be responsible for leading and advising regulatory staff on regulatory strategies and compliance activities for drug and biologic development programs, as well as future commercial activities.

Responsibilities
  • Management oversight of regulatory activities for assigned programs
  • Assume lead role in developing and guiding regulatory strategies to support successful development programs in oncology indications
  • Oversee the preparation of global regulatory development plans (RDPs) outlining strategic plans to achieve rapid oncology product development
  • Ensure that all projects have a clearly defined regulatory pathway and milestones leading to successful filings and approvals
  • Oversee the development and management of defining key regulatory timelines and regulatory critical path activities
  • Lead global health authority communications and preparation of submissions for assigned programs
  • Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards
  • Establish processes with Commercial and Legal to support reviews of promotional material and labeling activities to support future commercial products
  • Communicate effectively with the Senior Vice President of Regulatory Affairs and other senior management personnel (and external partners, where appropriate)

Requirement / Qualifications
  • BS or BA in a scientific discipline and/or equivalent experience; Advanced degree strongly desired with 10+ years in industry and at least 5+ years in Regulatory Affairs
  • Must have experience in small molecule drug development; biologics drug development experience highly desired.
  • Experience in preparing regulatory strategies (e.g., regulatory development plans), highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments
  • Previous experience in a senior regulatory role, including interactions with regulatory agencies (as lead regulatory representative) is desirable
  • In-depth understanding of regulations and guidelines governing all phases of drug development (for both drugs and biologics)
  • Excellent verbal and written communication skills including presentation skills
  • Experience with electronic submission process desirable

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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