Junior Regulatory Affairs Specialist CMC

Firmenname für PREMIUM-Mitglieder sichtbar

  • Mai 2021
  • Mai 2021
  • CH-Schweiz | Schweiz
  • auf Anfrage
  • 20.04.2021
  • CR/105406_1618845649

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Projektbeschreibung

New opportunity has been created for a junior Regulatory Affairs Specialist CMC in the global pharmaceutical company with HQ based in Basel.
Major Activities
1. Authoring CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
2. Prepare CMC responses to health authority questions during development, registration and product lifecycle.
3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
5. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
6. Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
7. Establish and maintain sound working relationships with partners and customers.
8. Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).

Requirements:
* Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
* Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
* Knowledge . experience of regulations, guidelines for NCEs and product life cycle maintenance for small molecules
* Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
* Effective planning, organizational and interpersonal skills.

This is a temporary contract role for till December 2021 with a great chance for extension.
Please send your CV ** Bitte beachten Sie, dass dieses Projekt in
einem Einsatzunternehmen in der Schweiz geplant ist, deshalb könnte es sein,
dass Ihnen eine alternative Vertragsform angeboten wird.

Sie finden dieses Projekt auf freelance.de,
da es in der Natur einem Freelance Projekt entsprechen sollte. **

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