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Job

Head of Regulatory Affairs and Quality Assurance

  • Location

    Boston

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Nikita Madan

  • Contact email:

    n.madan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    21 days ago

  • Expiry date:

    2020-07-15

  • Startdate:

    ASAP

RESPONSIBILITIES

  • Develops clinical and diagnostic regulatory strategies
  • Coordinates, writes, compiles, as appropriate, document packages for regulatory submissions from development, manufacturing, preclinical and clinical areas per regulations/guidelines and company SOPs to support regulatory applications.
  • Oversee the establishment, maintenance, and successful implementation of Regulatory & Quality processes and procedures
  • Reviews and approves investigator site regulatory documents (i.e. investigator documents, Informed Consents, IRB/EC documents) according to US FDA requirements and/or country requirements for initiation of clinical sites and drug shipments.
  • Ensure all interactions with Agency personnel (US/Ex-US) are conducted to the highest degree of professionalism.
  • Manage key relationships and strategic discussion with large pharmaceutical partners, ensuring program advancement, quality discussions, and desirable outcomes.

 

QUALIFICATIONS

  • Minimum 10 years combined experience in Regulatory Affairs, Experience in Quality Assurance preferred but not required.
  • Minimum 5 years of experience in regulatory oncology in a leadership capacity.
  • Excellent working knowledge of US and EU regulations and guidelines.
  • Successful regulatory filings associated with full life-cycle development: IND/NDA/MAA CTA, amendments
  • Minimum of a bachelor’s degree in a life science required. MS or PhD degree is preferred.