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Job

Regulatory Affairs Strategy Manager/Senior Manager

  • Location

    Massachusetts

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    120k-170k

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2021-09-17

  • Startdate:

    ASAP

Job title: Regulatory Affairs Strategy Manager/Senior Manager

Location: Massachusetts - Hybrid in office (2 days a week, or one week out of the month)

Salary: Dependent on level (120k-170k)

About the Role

  • Design, develop, and implement regulatory strategies across projects with a particular and focus on EU/UK and related regions;
  • Deliver regulatory strategy objectives for global regulatory support of nonclinical, CMC and clinical activities
  • Guide regulatory cross-functional team members and coordinate key deliverables;
  • Develop and maintain relationships with regulatory agencies, responding as needed; and
  • Provide strong regulatory guidance and serve as an internal consultant on relevant global regulations and guidelines

Qualifications:

  • Bachelor’s degree required 
  • Minimum of 3+ years of pharmaceutical/biotech industry and biologics experience preferred;
  • Have demonstrable proficiency in applying regulatory (FDA, EMA, and ICH) guidelines;
  • Experience in authoring, reviewing, and supporting product development from development to approval and beyond (e.g. product lifecycle management, tech transfers, variations, etc.);

 

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