Regulatory Affairs CMC Associate Manager (m/f/o)

Peppercorn - talent acquisition. For more than 30 years, we support our clients in the personnel recruitment for fixed and temporary placements. We are a financially independent company within the FAVORIS group.

For an international pharmaceutical company located in Basel we are looking for a:

Regulatory Affairs CMC Associate Manager (m/f/o)


Purpose:


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



Tasks & Responsibilities:
 

  • 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).


Requirements:
 
  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Fluent English required (oral and written)
  • Good German skills 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


Start date: 01.03.2021
End date:  17.12.2021, extention possible
Work location: Basel
Workload: 100%


 
Interested?
We look forward to your application via our homepage


Peppercorn Human Experts AG
Auberg 2
4051 Basel


Anja Glinschert
Telefon: 058 255 31 01

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