Regulatory Affairs CMC Manager

☞ Randstad Switzerland

View: 140

Update day: 26-03-2024

Location: Basel Basel-Stadt BS

Category: Legal / Contracts

Industry: Staffing Recruiting Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

For our pharmaceutical client in Basel, we are looking for a

Regulatory Affairs CMC ManagerStart: asap

Contract: until Dec 2021, with possibility of extension

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

Major Activities
  • 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.
  • 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.
  • 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).
Ideal Background:
  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
  • Languages: Fluent English required (oral and written).
Experience/Professional requirement:
  • 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.
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Deadline: 10-05-2024

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