Regulatory Affairs Consultant

Location
South West England
Salary
£50 to £75 per hour
Posted
02 Aug 2019
Closes
16 Aug 2019
Ref
J5631974
Contact
Haseena Mooncey
Contract Type
Contract
Hours
Full Time
We are currently looking for a Regulatory Affairs Consultant to join a leading Biopharmaceutical company based in the South West. As the Regulatory Affairs Consultant you will be responsible for taking the lead in preparing and reviewing all elements required for EU Centralised Filing applications for the European Medicines Agency (EMA).

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Regulatory Affairs Consultant 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. As the Regulatory Affairs Consultant be the Project Lead and will review available data, conduct gap analysis as well as ensuring budgets and timelines maintained.

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

4. In your role as the Regulatory Affairs Consultant, 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, co-ordinating 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.