ID EXISTS
POS 4086
Status 5
DJM 1

Regulatory Affairs CMC Manager

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: Regulatory Affairs CMC Manager
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Tasks:
  • Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies
  • 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)
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Qualifications:
  • Start: 01.12.2020 // Duration: 12 months // Capacity: 40h/week onsite
  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • 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
  • Languages: Fluent English required (oral and written), Good skills in site (local) language desired (oral)
Bemerkungen: WANTED: Regulatory Affairs CMC Manager (M/F/D). Please contact +41 71 577 27 41 or franziska.spindler@k-recruiting.com Skills: CMC (Regulatory Affairs), English, German, Pharma, Regulatory Affairs
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Interesse geweckt?
Auf geht's!
Beginn: 01.12.2020
Laufzeit: 12 months
Einsatzort: Basel, Switzerland
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