Senior Regulatory Affairs Associate

Location
Buckinghamshire
Salary
Competitive
Posted
15 Nov 2018
Closes
13 Dec 2018
Ref
J5630486
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
A Fantastic opportunity for a Senior Regulatory Affairs Associate has become available within a leading Global Pharmaceutical company based in the Buckinghamshire area. As the Senior Regulatory Affairs Associate you will be responsible for supporting the execution of product registration strategy across EU markets and will assist with the product maintenance and life cycle. In addition, you will gain exposure to clinical development strategy.

KEY DUTIES AND RESPONSIBILITIES:

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

1. You will assist with the planning and implementation of regulatory activities to support life cycle management and maintenance of a range of projects including but not limited to small molecule, large molecule and ATMP therapeutics.

2. With supervision, you will support co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.

3. Support drug development strategy including Scientific Advice, PIP, IMPD and the creation of briefing packages while ensuring filling strategy is adhered to for CP, MRP and DC procedures.

4. You will have the opportunity to sit on Global regulatory teams to represent the EU regulatory team and build upon your knowledge and experience to effectively offer regulatory advice and intelligence.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Pharmacology etc.) in addition to experience in a Regulatory Affairs setting.

2. Proven industry experience working as a Regulatory Affairs professional with knowledge of either Drug Development strategy (e.g. Scientific Advice, PIP applications, IMPD etc.), MAA submission or Life Cycle Maintenance (e.g. Variations, renewals, extensions etc.)

3. A working knowledge of Regulations and guidelines for EU procedures and markets.

Key Words: Regulatory Affairs Associate | Regulatory Affairs Officer | Regulatory Affairs Analyst | EU | Europe | CP | Centralised Procedures | DCP | Decentralised Procedures | MRP | Mutual Recognition Procedures | Variations | Renewals | MAA Submissions | Strategy | CMC | PIP | Scientific Advice | Labelling

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 processionals and scientists. We look forward to helping you with your next career moves.

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