My client, based in the Netherland are currently recruiting for a Regulatory Professional on a Freelance basis in the therapeutic area Immunology. The client's product portfolio focus in the areas of rheumatology, gastroenterology, dermatology and pulmonology.
- Input in development, post approval and Life cycle management
- Liaison with Regulatory Agencies and Local Operating Companies
- Act as backup for contact with Regulatory Agencies as needed
- Assist in the preparation of meetings with Regulatory Agencies
- Liaise with LOCs, track and respond to queries in a timely manne
- Support of Marketing Authorization Applications (MAA) in EMEA region:
- Provide regulatory support throughout lifecycle management
- Clinical Trial Applications (CTA)
- Advise team on required documents and submission strategies in preparation of CTAs
- Ensure CTA submission packages are complete and available according to agreed timelines
- Review and approve clinical trial supply plans
- University degree in Life Sciences (pharmacy, biology, veterinary etc.), or equivalent by experience;
- 4-8 years of relevant experience
- Experience in MAA, CTAs and Lifecycle management is desired.
- Knowledge of the regulatory environment, guidelines and practice of EMEA regions
- Team work experience.
- Project Management
- Oral & Written communication skills
- Fluency in English
- Organisation and multi-tasking
If you or anyone you know might be interested in this role- please do not hesitate to contact Reesa Berry on +441483 397070 or send an email to email@example.com