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Job

Senior Manager/Associate Director Regulatory Affairs CMC

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Antoinette Miller

  • Contact email:

    a.miller@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Expiry date:

    2022-08-22

  • Startdate:

    ASAP

This company is a world-leading player in the field of cardiology and aims to become a recognized and innovative player in oncology. Its growth is based on a constant commitment to cardiovascular and metabolic diseases, oncology and immune-inflammatory and neurodegenerative diseases. They recently increased its presence in the US by the acquisition of Oncology products to expand its portfolio.

They are an organization, committed to modelling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description.

 

SUMMARY OF ROLE:

Experienced Regulatory CMC specializing in biotechnology products. You’re responsible for the Module 3 (Quality) of our Marketing Authorisation for biologics. Your mission is to drive and perform regulatory activities linked to development, variations and/or international submissions of Marketing Authorisation Applications (MAAs) and BLAs. As part of the Global regulatory CMC team, you define the CMC regulatory strategy in partnership with other Regulatory actors (i.e.: Associate Director, Global Regulatory). Moreover, you will be working in close collaboration with pharmaceutical development and industrial colleagues to provide regulatory impact assessments on tech transfer, scale-ups or method changes, for example.

Specific Responsibilities:

  • Lead and develop balanced risk-based global regulatory CMC strategies for all investigational and marketed products. Proactively contribute to and influence product development and life-cycle management.
  • Effectively manage regulatory CMC aspects of projects including the preparation and submission of CMC sections of dossiers supporting clinical trial applications (i.e. IND/IMPD/CTA submissions), annual reports and marketing applications globally (i.e. US, EU, China, Eurasia, Brazil, etc.)
  • Coordinate and contribute to the life cycle management (variations in EU, CBE, PAS, renewal of application) at the international level (i.e. US, Europe, Japan, Canada, China, etc.)
  • Ability to represent RA CMC in global cross-functional Operations teams including Manufacturing, Quality, CMC/MSAT, Supply Chain, Product Strategy
  • Leads the preparation of CMC documents in response to Health Authority or Agency requests for information, meeting briefing books to support Scientific Advice interactions
  • Specific quality / regulatory activities include
  1. Management of Out Of Specification (OOS for batches under stability)
  2. Follow up of CMC commitments for the product under responsibility
  3. Review of Product Quality Review (PQR) production and regulatory review of PQR
  4. Contribute to Change Control procedures and evaluation: Regulatory impact analysis
  5. Compliance with the Quality Manual and Quality System of the Company
  • Ensure documents meet regulatory requirements, standards and quality compliance
  • Stay up to date on US, EU and International regulatory guidelines in specific areas

Qualifications:

  • Strong regulatory strategic skills and ability to be successful in a multi-faceted environment
  • Knowledgeable in ICH, FDA and EMA guidelines and requirements
  • Experience working collaboratively in multi-functional teams
  • Ability to work harmoniously across a variety of U.S. and global teams
  • Well organized, scientifically driven, detailed oriented, pragmatic and open
  • Excellent critical thinking and problem-solving skills
  • Comfortable with and capable of prioritizing multiple tasks, projects and objectives
  • Able to exercise discretion and confidentiality in a consistent and professional manner
  • Excellent attention to detail with strong verbal and written business communication skills

Skills and Education:

  • Graduate of a biotechnology-relevant degree or with acquired biotechnology experience or equivalent experience. 5 years relevant CMC/Regulatory CMC pharmaceutical industry experience
  • Prior direct, hands-on experience in the preparation and oversight of CMC submissions (INDs, IMPDs, NDAs and/or MAAs)
  • Demonstrated knowledge of eCTD elements, structure and content; expertise in Module 3
  • Strong knowledge and experience in CMC product development and in working collaboratively on internal/external/partnered cross-functional CMC teams

Other Relevant Information:

  • Some travel