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Life Sciences Stellen Basel

Regulatory Affairs CMC (Associate) Manager, 100% (m/f)

Temporärstelle
Einritt:
Stelle: Life Sciences
Art: Temporärstelle

Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

Our customer, a pharmaceutical company based in Basel, needs reinforcement. For a temporary employment (1 year) we are looking for a

Regulatory Affairs CMC (Associate) Manager, 100% (m/f)

Major accountabilities:

  • Author high-quality 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.
  • Prepare CMC responses to health authority questions during development, registration and product lifecycle.
  • Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • 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.
  • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
  • Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
  • Establish and maintain sound working relationships with partners and customers.
  • 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).

Background:

  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
  • Fluent English required (oral and written).
  • Good skills in site (local) language desired (oral)
  • Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
  • 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 desirable.
  • 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.
  • Reasonable approach to risk assessment.
  • Excellent written/spoken communication and negotiation skills.
  • Computer literacy.

For questions

… please contact Mr. Renato Imboden by phone on 061 269 90 60

Our current Job-offers: www.edp-basel.ch / www.stellen-basel.net

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