Regulatory Affairs
- East Anglia
- Contract
- Drug Safety / Pharmacovigilance
Our client has an exciting new opportunity for a X to join the team. Our client has specialised in pharmaceutical products and people's well-being for over a century and work with some well-known household brands.
Responsibilities:
- Supports the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities for MRP/DCP products
- supports the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
- Supports the team with regional regulatory strategies in line with business plan for post-approval activities.
- Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
- Prepares and compiles regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
- Ensure Marketing Authorisations are maintained and renewed.
Requirements:
- Life sciences or chemistry graduate to honours level or equivalent.
- Works with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
- Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
- Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc
- 2/3 days on site in High Wycombe
If this role is of interest to you, please apply now!
#LI-KT1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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