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Job

Director Regulatory Affairs - CMC

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Fahd Joudi

  • Contact email:

    f.joudi@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    17 days ago

  • Expiry date:

    2022-12-05

  • Startdate:

    ASAP

Overview:   

In partnership with the Vice President of CMC Affairs, the Director CMC Regulatory Affairs acts as a  regulatory lead for large molecules CMC programs by providing regulatory strategy and support to development teams.

Principle Responsibilities and Duties:

  • Develop and execute CMC regulatory strategies for large molecule products in early-, late-development and commercialized products.
  • Represents CMC Regulatory Affairs at project team meetings and coordinates workflow between departments
  • Interfaces with external regulatory groups, such as contract manufacturers and development partners
  • Coordinates, writes, compiles, document packages for regulatory submissions per regulations/guidelines and company SOPs to support regulatory applications including investigational and marketing applications (IND, CTA, BLA, MAA), etc.
  • Maintains CMC Regulatory document control system.
  • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline areas relevant to assigned projects.
  • Contributing to interactions with regulatory authorities as needed.
  • Participates in department initiatives to improve standards and systems internally and maintain relationships with other departments including consultants and vendors.

Education, Experience and Background:

  • BS/MS or PhD a in life sciences field
  • Experience in Antibody Drug Conjugates
  • Experience with large molecules “Monoclonal Antibody highly preferred”
  • Writing experience “module 3” is a plus
  • Chinese language proficiency preferred
  • Ability to manage multiple and varied tasks in a fast-moving environment, with excellent project management skills.
  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, and working collaboratively with pharmaceutical partners are required.
  • Must be highly collaborative, with strong communication skills

 

What’s in it for you?

  • REMOTE
  • Competitive Base/ Bonus/ Equity Package
  • 401k with 7% employer matching
  • Comprehensive Insurance plan
  • PTO
  • Joining a $13 Billion worth company that never had layoffs and is planning for a 200% growth in 2022

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