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EMEA Regulatory Affairs Contract or Pharmaceuticals - 6-Month Contract
Our client has an exciting new opportunity for a regulatory affairs contractor to join the team. They have specialised in pharmaceutical products and people's well-being for over a century, working with some well-known household brands.
Responsibilities:
1. Support the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products across EEA and coordinate worksharing (WS) procedures for CMC and non-CMC variations, when WS is appropriate.
2. Assist the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
3. Support regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
4. Prepare and compile regulatory submissions (Variations, renewals, PSUSA, etc.), responses to Regulatory Agency (RA) questions, and other correspondence in accordance with EU regulations and guidelines.
5. Maintain EAME databases (RegPoint, HAQ) accurately.
Requirements:
1. Life sciences or chemistry graduate to honours level or equivalent.
2. Ability to work with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet departmental and company objectives.
3. Proficiency in developing approaches to solutions with technical guidance on moderate scope and complexity problems.
4. Understanding of project management, regulatory environment, interaction with Regulatory Authorities (as appropriate), commercial/strategic awareness, implementation of regulatory strategy, and managing Marketing Authorisations.
5. This is a hybrid role with 1-2 days in the office per week.
If this role interests you, please apply now!
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