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Senior Manager, Regulatory Affairs CMCs

Your Job

  • Provides a wide range of flexible regulatory affairs services for different clients on a range of product types and therapeutic areas.
  • Preparation and maintenance of registration documentation for pharmaceutical product application and other submissions e.g. variation with focus on CMC documentation
  • Support CMC activities including: CMC project management (local and global projects), review and writing of CMC gap analysis and CMC strategies.
  • Develop timelines for regulatory activities and ensure execution
  • Liaison with regulatory authorities
  • QC review of documentation, compendial cross checking and report formatting.
  • Critical technical review of documentation based on established experience.
  • Consulting support for CMC activities
  • Contribute in the development of the business area in the Nordic region within CMC/GMP

  • Key Decisions made by the role

  • Day to day technical decisions with regards to the criticality of technical content of documents/data under review.
  • Day to day decisions regarding the level and type of consulting advice provided and whether additional
  • Day to day project management decisions to ensure project is delivered as requested (time/quality)

  • Your Profile

  • University degree in pharmacy or other natural sciences
  • Experience from the medicinal industry or regulatory authorities
  • Experience in evaluation, preparation and compilation of quality documentations and/or experience in regulatory processes (registration procedures, renewals, variation).
  • Established experience in regulatory affairs activities including: Module 3, MAA gap analysis, regulatory strategy with focus on CMC
  • High-quality mindset.
  • Ability to work in a team.
  • Strong sense of responsibility.
  • Ability to implement tactical goals of customer or internal projects within daily work
  • Structured, analytical, systematic and independent manner
  • Professional written and spoken communication skills with internal and external customers, colleagues and supervisors. Experienced user of the MS-Office package, Adobe Acrobat and database systems
  • English language fluency, written and spoken

  • For further information please don’t hesitate to contact us:

    Anne Mette Gliese
    Senior Director, Head of Regulatory Affairs, Nordic Region
    annemette.gliese@pharmalex.com

    Agencies only by prior agreement for the specific job opportunity.


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