Senior Regulatory Affairs Manager - EU

Location
Buckinghamshire
Salary
Competitive
Posted
16 Nov 2018
Closes
14 Dec 2018
Ref
J5630506
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
A leading Global Pharmaceutical company based in Buckinghamshire are looking for an experienced Regulatory Strategist to join them as their Senior Regulatory Affairs Manager. As the Senior Regulatory Affairs Manager you will be responsible for the implementation of registration strategy for products to EU markets as well as the successful life cycle maintenance of a range of products including small and large molecules and ATMP products.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Lead drug development strategy through defining the need for Scientific Advice, PIP, IMPD applications and the co-ordination of agency meetings including briefing packages. You will also support clinical trial strategy.

2. You will ensure the successful approval of MAA submissions to EU markets through effective filing strategy including CP, MRP and DC procedures. You will asses the risks and issues and perform gap analysis to critically review submissions.

3. Drive the regulatory activities to support life cycle management and maintenance through appropriate variations and renewals submissions. You will also co-ordinate the review of CMC, QRD, PSUR and labelling submissions

4. You will sit on Global Regulatory project teams and input in to regulatory strategy ensuring EU needs are met. You will support junior members of staff and ensure that new processes are developed and implemented to maximise efficiency and so they follow global strategy.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Manager 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 extensive Regulatory Affairs experience, ideally with a strong focus on product Strategy.

2. Proven industry experience in a Pharmaceutical / Biopharmaceutical Regulatory Affairs setting where you have gain hands on experience across all areas including Drug development, MAA submission and life cycle maintenance. Small or large molecule experience is welcome with knowledge of GI products benefiting your application.

3. Applicants must have an excellent level of communication, both written and verbal. You must demonstrate strong project management skills including planning and organisation. You will need to demonstrate your ability to lead and hold your on in global projects meetings.

Key Words: Regulatory Affairs | Senior Manager | Project Management | EU | Europe | Centralised Procedures | Decentralised Procedures | Mutual Recognition Procedures | CP | DCP | MRP | MAA | Drug Development | Clinical strategy | PIP | PRIME | Scientific Advise | IMPD | CMC | QRD | PSUR | Labelling | Leader |

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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