Job Description
This is an opportunity to be a part of a growing Regulatory Affairs group for an international pharmaceutical company. This role will involve managing new products and projects and will be part of a small, but experienced Regulatory Affairs team.
The Role:
- Communicating with the MHRA at a strategic level
- To respond to questions from regulatory authorities raised during technical reviews of submissions, variations and renewals
- To ensure the company’s manufacturer (MIA) and wholesale dealer (WDL) licenses are maintained and up to date to allow importation and distribution of all of the company’s products
- To support the regulatory department for eCTD submissions by either National, DCP or MRP procedures
- To prepare submissions of license variations and renewals to strict deadlines
- Leading key projects and working with key stakeholder across the business
- Gaining an understanding of pharmacovigilance practices and procedures
- Gaining exposure to the drug development process
Applicant Requirements
- Strong & proven Regulatory Affairs Technology Transfer experience
- Excellent project management experience