Our client, a large international generic Pharmaceutical company, is seeking a professional to fulfill a temporary role as a (Senior) Regulatory Affairs Officer, to cover maternity leave.
As a Senior Regulatory Affairs Officer, your primary responsibility will be to compile and maintain the CMC (Chemistry, Manufacturing, and Controls) sections, specifically modules 2 and 3, of medicinal product dossiers for global registrations. These dossiers pertain to medicinal products manufactured in the Haarlem region.
- Establishing priorities and planning for products within the portfolio.
- Compiling registration dossiers and variation packages.
- Gathering and processing data and information from various company departments to ensure dossier compliance and currency.
- Evaluating change controls for their impact on registrations and implementing necessary dossier updates across multiple markets for products manufactured in Haarlem.
- Interpreting international regulations and providing guidance on their implementation.
- Providing coaching and support to other team members.
- Communicating dossier content to other departments.
- Offering strategic advice on the submission of registration dossiers and variations in diverse markets.
- Addressing inquiries from Health Authorities, foreign representatives, third parties, and maintaining strong relationships with external stakeholders.
- Identifying opportunities for process enhancements and proposing their implementation.
- Representing Site Regulatory Affairs in cross-functional project teams.
- Academic background with a focus on chemistry/pharmaceuticals.
- Several years (preferably ~4) of experience in CMC Regulatory Affairs or in a QA/QC role within the pharmaceutical industry.
- Proficiency in registration procedures and pharmaceutical regulations.
- Proficient in both spoken and written English.
- Comfort working with various software, including Document Management Systems.
- Strong attention to detail and the ability to prioritize tasks while adhering to established timelines.
- Excellent communication skills.
- Capacity to work independently with minimal supervision.
- Problem-solving abilities and the capability to identify and implement process improvements.
- A collaborative team player.
- 6 month contract, with a possibleextension of 2 monthsthroughOxford
- Salary indication; €4000 - 6000,- based on a fulltime (40 hour) workweek
- 32 hours is discussable
- Partly remote work (3 days on-site when working 40 hours)
- Region; Haarlem
Vacancy number; 23621