EMEA Regulatory Affairs

Quanta part of QCS Staffing; Buckingham; Hybrid; GBP 35,000 - 50,000; Full time

Job summary

A leading company in pharmaceuticals is seeking a Regulatory Affairs Contractor to work with their EMEA team for a 6-month hybrid role. The successful candidate will support regulatory activities, manage submissions, and ensure compliance with EU regulations. Ideal for a life sciences graduate with strong project management skills, this position offers the chance to work with well-known brands in the pharmaceutical industry.

Qualifications

• Honours level or equivalent in Life Sciences or Chemistry.
• Ability to work independently on regulatory submissions.
• Experience with regulatory procedures in European contexts.

Responsibilities

• Support EMEA Regulatory Affairs team with post-approval activities.
• Prepare and compile regulatory submissions and related correspondence.
• Maintain EAME databases accurately and regularly.

Skills

Project Management

Regulatory Strategy Implementation

Technical Problem Solving

Education

Life Sciences or Chemistry Graduate

Tools

RegPoint

HAQ

Job description

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EMEA Regulatory Affairs Contract or - Pharmaceuticals - 6-Month Contract

Our client has an exciting new opportunity for a regulatory affairs contractor to join the team. The company has specialized in pharmaceutical products and people's well-being for over a century, working with some well-known household brands.

Responsibilities:

1. Support the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products across the EEA and coordinate worksharing (WS) procedures for CMC and non-CMC variations, when WS is appropriate.
2. Assist with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
3. Assist with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
4. Prepare and compile regulatory submissions (Variations, renewals, PSUSA, etc.), responses to Regulatory Agency (RA) questions, and other correspondence in accordance with EU regulations and guidelines.
5. Maintain EAME databases (RegPoint, HAQ) accurately and regularly.

Requirements:

1. Life sciences or chemistry graduate to honours level or equivalent.
2. Ability to work with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
3. Capable of developing approaches to solutions with technical guidance on problems of moderate scope and complexity.
4. Experience in project management, understanding of the regulatory environment, interaction with Regulatory Authorities (as appropriate), commercial/strategic awareness, implementing regulatory strategies, and managing Marketing Authorizations.
5. This is a hybrid role requiring 1-2 days in the office per week.

If this role interests you, please apply now!

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