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EU Regulatory Lead

Slough, BerkshirePermanent
Experience Dependent
Job Reference: J5633712
Updated On: 17/09/2020
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology

Skills: Regulatory Affairs - Permanent, Regulatory Affairs - EU, Regulatory Affairs - Manager / Director / Executive, Regulatory Affairs - Registrations, Regulatory Affairs - Biologics

Job Information

Role Overview

We are currently looking for a EU Regulatory Lead to join a leading Biopharmaceutical company focused on the development Neurology and Oncology products. As the EU Regulatory Lead you will be responsible for management on a product portfolio and will lead the EU strategy generation and execution for new indications and life cycle management.

This position could be based in Berkshire, UK or from Belgium and is a product leadership level opportunity where previous EU strategy Leadership experience is required.

Key Duties and Responsibilities

Your duties as the EU Regulatory Lead will be varied however the key duties and responsibilities are as follows:

1. You will develop and implement strategy for pre-registration activities such as PIPs, ODD and Scientific Advice meetings to ensure the continued development of life changing pharmaceutical products. You will also lead the continued maintenance of the products, directing matrix teams on post marketing activities such as Variations, Renewals and market expansions.

2. You will work closely with Global Regulatory Leads to input your regional expertise for global regulatory strategy and ensure the successful development of the product portfolio.

3. You will lead a matrix team and work cross functionally with CMC Regulatory teams as well as Medical, Supply Chain and commercial teams.

4. You will the main point of contact for European regulatory agencies including the EMA for centralised products. You will lead all interactions with the agencies and ensure regulatory risks have been identified and mitigated.

Role Requirements

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

1. Relevant degree in a Life Sciences discipline (e.g. Biology, Pharmacology, Molecular / Cellular Biology etc.) in addition to extensive Regulatory Affairs experience where you have developed, registered and maintained products in Europe, ideally with experience on Centralised Procedures.

2. Proven industry experience in developing strategy for product development including pre-registration activities and product licensing. Experience of the continued development of marketed products would be advantageous.

3. A working knowledge and practical experience with life cycle management strategy development including line extensions and safety variations,

Key Words: Regulatory Affairs | Product Development | Product Registration | Strategy Development | Life Cycle Management | Matrix management | Global Regulatory Strategy | Risk Management
Georgia Walden
Your Recruitment ConsultantGeorgia
DisclaimerHyper 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.