vor 10 Tagen

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

nemensis AG

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

For our client, an international pharmaceutical company, we are in search for a Regulatory Affairs CMC Associate Manager in the region of Basel.

What the company offers you:

  • An international environment
  • Modern building
  • Company is easily reachable by car or public transport
  • Interesting project till 20.12.2019 with chances of extension

Your responsibilities:

  • Authoring high-quality CMC documentation for HA submission by applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle
  • Identifying 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
  • Keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
  • Establishing and maintaining sound working relationships with partners and customers
  • Assuming 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

Your profile:

  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Regulatory experience
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
  • Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable
  • Reasonable approach to risk assessment as well as excellent written/spoken communication and negotiation skills
  • Fluent English (oral and written). Good skills in site (local) language desired (oral)

Welcome to nemensis!

We are looking forward to getting to know you!