Regulatory CMC Associate Manager

Reference Number: 895759-W
Type of placement: Contract, 10 Months
Location: Switzerland, North West

Introduction:

Our client is a global pharmaceutical company currently looking for a Regulatory CMC Associate Manager.

Main Responsibilities:

  • Author high-quality CMC documentation for Health Authority (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 Drug Reg Affairs Global Regulatory Compliance System 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). view of clinical study data for cardiovascular diseases
  • Perform ongoing review of clinical data using patient profiles and data listings
  • Perform data reconciliation
  • Generate and close data queries in OC-RDC system (e-CRF). 

Qualifications and Experience:

  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent is preferred. Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent is a plus 
  • Minimum 2 years of Regulatory experience and/or experience in drug/biopharmaceuticals
  • 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
  • Excellent written/spoken communication and negotiation skills
  • Sound knowledge of English is required, good knowledge of German is desired
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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