Regulatory Affairs Lead

Location
Wiltshire
Salary
Industry Competitive
Posted
01 Aug 2019
Closes
29 Aug 2019
Ref
J5631972
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions have an exciting Regulatory Affairs opportunity for a Regulatory Affairs Manager experienced in developing EU Strategy for MAA submissions. This opportunity is within a leading Biopharmaceutical company based in the Wiltshire area where they are offering relocation or flexible home working options.

As the Regulatory Affairs Lead with will take the lead in coordinating, evaluating, preparing and reviewing all the elements required for the application and you will work closely with the Head of Regulatory Affairs and company Managing Director.

This is a fantastic opportunity for a Senior Regulatory professional looking to have full project ownership and to be accountable for a company defining project.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Develop submission strategy for an MAA filing to the EMA under EU Centralised Procedures.

2. You will be the Project Lead and will review available data, conduct gap analysis as well as ensuring budgets and timelines maintained.

3. You will work closely with company Senior Executives and company Managing Director as well as Directors across Manufacturing and Quality to ensure successful project delivery.

4. You will work cross-functionally internally as well as being the main point of contact for Regulatory Authority interactions.

5. You will need to be pragmatic in your strategic approach and understand the key strategic regulatory challenges associated with Biologic Pharmaceuticals while also undertaking critical decision-making.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Life Sciences (e.g. Biology, Biochemistry, discipline where understand and experience of Biological product manufacturing and registration is preferable.

2. Proven industry experience in a Regulatory Affairs setting where you have developed submission Strategy to EU markets under Centralised Procedures is vital to your application.

3. Experience of preparing, coordinating and reviewing responses to EU regulatory authorities.

4. Be able to write and critical review technical documents and CTD/eCTD sections.

Key Words: Regulatory Affairs | Senior Manager | MAA | Marketing Authorisation Application | CP | Centralised Procedures | EMA | European Medicines Agency | EU | Strategy | Due Diligence | Regulatory Lead |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.