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Regulatory Affairs Manager / Director

Eingestellt von Bio Careers

Gesuchte Skills: Client

Projektbeschreibung

REGULATORY AFFAIRS MANAGER /DIRECTOR

SAN FRANCISCO & SAN DIEGO, CA

Due to rapid and continued growth, Pharmalink Consulting, a dynamic regulatory services provider, is expanding its operations.  This has created the need for additional Regulatory Affairs Managers and Directors.

Based in and around San Francisco and San Diego, these roles will be multi-functional, including the application of technical knowledge, supporting client business development, and depending upon your level of experience may vary in nature and scope.   

We are looking for candidates with various regulatory backgrounds including areas such as :

- Consumer products, generics and biologics
- US and International regulatory experience

THIS ROLE IS RESPONSIBLE FOR:

- Preparing and compiling components for regulatory applications, such as , IND, IDE, CTA, NDA, sNDA, ANDA, Annual Reports, BLA, 510k, MAA, variations, renewals
- Directing others in the preparation of high quality, detailed regulatory documents.
- Advising on regulatory strategy and executing specific regulatory projects
- Interacting with regulatory authorities on specific project / product issues as required
- And depending upon level of experience, may also be responsible for:
- Managing all parts of a regulatory project including overall strategy, resource, costs, time and clients. Choose the method and processes of work to achieve overall objectives. Ensure that project work proceeds according to agreed deadlines and maintaining status records 
-  
- Assuming responsibility for a functional area or have a unique contribution to a department
- Working with the commercial team on proposal preparation and visiting client sites with new and existing clients
- Managing a team of direct reports

Projektdetails

  • Einsatzort:

    Short Hills, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung

  • Skills:

    client

Bio Careers