Job Description
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 | Generics |