We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Our Regulatory Affairs team in the Nordics is growing, and we are looking for a new team member to be based in Hørsholm, Denmark.
Senior Manager, Regulatory Affairs CMCs
This role provides a broad range of regulatory affairs support for the regulatory function, with a particular focus on CMC.
This position will lead and support CMC activities for local and international PharmaLex projects.
- 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)
- 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
Agencies only by prior agreement for the specific job opportunity.