Senior Registration Officer

4 days ago

Hatfield, United Kingdom VECTOR GLOBAL SOLUTIONS LIMITED Full time

**Senior Registration Officer (EU Submissions)**

Job Ref**:R5605624**

Location**:Hatfield**

Division**:Generics [U.K.] Ltd.**

Our Client sees healthcare not as it is but as it should be. They act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Our Client empowers people worldwide to live healthier at every stage of life.
They do so via:

- Access - Providing high quality trusted medicines regardless of geography or circumstance;
- Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
- Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, they rise to the challenge to make a difference and here’s how the Senior Registration Officer (EU Central) role will make an impact:
Key responsibilities for this role include:

- Ensure on-time submissions for all safety related changes for assigned projects.
- Ensure databases and systems (including Documentum, MyPortfolio and TrackWise) are updated in-line with current SOPs and up-to-date information is available for all assigned products.
- Ensure SPPs for all assigned projects are maintained in-line with current SOPs and guidance.
- Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.
- Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.
- Be actively involved in due diligence activities including evaluation of regulatory strategy and launch timelines, evaluation of risks and regulatory costs.
- Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.
- Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes.

The minimum qualifications for this role are:

- BSc in Life sciences or related area.
- Regulatory Affairs experience working in a pharmaceutical company is ideal.
- Proficiency in speaking, comprehending, reading and writing English.
- Excellent prioritization and time-management skills.
- IT literate with proficiency in using word, excel, power point.

Our Client offers competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Our Client is an Equal Opportunity Employer.

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