Senior Regulatory Affairs Officer

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Experience Dependent
Job Reference: J5639127
Status: Now Interviewing
Updated: 12/06/2024

Role Overview

We are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Kent area. As the Regulatory Affairs Manager, you will play a pivotal role in managing the life cycle and post-authorisation changes for products within the UK, focusing on CMC, clinical, safety, and product information modifications.

Your expertise will be instrumental in writing, compiling, and publishing dossiers for UK National & EU submissions, ensuring compliance with regulatory requirements.

Key Duties and Responsibilities

Your duties as the Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:

1. Oversee dossier compilation and submission for UK and EU markets.

2. Liaise with regulatory bodies and manage communication regarding variations.

3. Develop product information and approve artwork for regulatory compliance.

4. Ensure that CMC practices align with regulatory standards, developing clear justifications for new product licenses and variations.

Role Requirements

To be successful in your application to this exciting role as the Regulatory Affairs Manager, we are looking to identify the following on your profile and past history:

1. Educated to degree level in science or equivalent experience.

2. Proven experience in Regulatory Affairs within the Pharmaceutical industry.

3. Strong communication and project management skills.

4. Proficiency in MS Office suite and regulatory submission portals.

Key Words: Regulatory Affairs Officer | Pharmaceutical | Life Cycle Management | CMC | Clinical | Safety | Product Information | Dossier | Submission | Variations | MA Transfer | eCTD | EMC | MHRA | CESP | Artwork | Pharmacovigilance |
Interested in this job? Apply for this position now!

Rhea Rughani

Your Recruitment Consultant:

Rhea Rughani


Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
Sectors: Pharmaceutical
Skills: Regulatory Affairs - Permanent, Regulatory Affairs - EU, Regulatory Affairs - CMC, Regulatory Affairs - Generics
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