Senior Regulatory Affairs Officer

TN United Kingdom; England; On-site; GBP 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a Senior Regulatory Affairs Officer to join their dynamic team in the Kent area. This pivotal role involves managing the life cycle and post-authorisation changes for pharmaceutical products, ensuring compliance with UK and EU regulations. Your expertise in writing and compiling dossiers will be crucial for successful submissions. The ideal candidate will have a strong background in Regulatory Affairs, excellent project management skills, and proficiency in relevant software tools. Join a forward-thinking company where your contributions will significantly impact the pharmaceutical landscape.

Qualifications

• Educated to degree level in science or equivalent experience.
• Proven experience in Regulatory Affairs within the Pharmaceutical industry.

Responsibilities

• Oversee dossier compilation and submission for UK and EU markets.
• Liaise with regulatory bodies and manage communication regarding variations.

Skills

Regulatory Affairs

Project Management

Communication Skills

CMC Practices

Education

Degree in Science

Tools

MS Office Suite

Regulatory Submission Portals

Job description

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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 for this exciting role as the Regulatory Affairs Manager, we are looking to identify the following on your profile and past experience:

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