Global Regulatory CMC - CELGJP00007995

  • Location

    Hayes, London

  • Sector:

    Healthcare

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Jakub Rurkowski

  • Contact email:

    Jakub.Rurkowski@experis.co.uk

  • Job ref:

    BBBH104586_1559735189

  • Published:

    4 months ago

  • Expiry date:

    2019-07-05


Global Regulatory CMC - 6 months
Global Regulatory CMC - 6 months

The work location is based in Stockley Park on 6-months contact duration

Degree in Scientific Discipline (Masters or higher preferred) with 5-7 years in the pharmaceutical industry or in CRO, including at least 3 years CMC regulatory experience

Responsibilities will include, but are not limited to, the following:

1. Participate in the development of the CMC regulatory strategy for submissions with an emphasis on international regions. These submissions include CTA/MAA regulatory filings.
2. Collaborate with Regulatory CMC project leads and other relevant line functions to prepare CMC submission documents, registration dossiers, and responses to health authorities for responsible regions.
3. Participate in the regulatory evaluation of CMC change controls by liaising with Regulatory CMC project leads and Regulatory Affairs International to determine regulatory impact for responsible regions.
4. With supervision, will be responsible for the management of Regulatory CMC activities related to commercial compounds for responsible regions.
5. Represent Regulatory CMC on Regulatory Affairs International teams.
6. Participate in document review meetings and discussions for responsible regions.
7. Develop internal knowledge base for CMC international activities including submission document requirements and working practice for interacting with country affiliates.

Skills/Knowledge Required:

  • Experience with CMC regulatory documents (variations, responses and CTAs) and with registration dossiers for worldwide use
  • Knowledge of ICH guidelines and CMC regulations for international regions
  • Experience in developing global CMC regulatory strategy
  • Experience in managing post approval Regulatory CMC activities globally
  • Have a solution-oriented approach to problem solving
  • Ability to work on complex projects and within cross-functional teams
  • Excellent grammar and communication skills, both written and oral