Job Description

We are currently looking for a Regulatory Affairs Consultant to join a leading Pharmaceutical company on an initial 12 month contract. As the Regulatory Affairs Consultant you will be responsible for execution and authoring EU regulatory activities to obtain and maintain MAs (Marketing Authorisations).

Please note this role can offer remote working and is for an initial 12 month contract.

Key Duties and Responsibilities

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

1. The Regulatory Affairs Consultant will work with the Regulatory Lead and act as point of contact for assigned Orphan Drug Product Registrations.

2. The Regulatory Affairs Consultant will work with third party vendors and provide regulatory strategy expertise as appropriate.

3. The Regulatory Affairs Consultant will ensure all documentation is captured using electronic document management systems and deliver excellent regulatory submissions in line with company and project objectives.

4. The Regulatory Affairs Consultant will be an established RA professional, with experience of EU regional regulatory procedures and submission formats such as eCTDs. Experience with orphan products is an important requirement.

Role Requirements

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

1. Relevant degree in a Pharmaceutical/Scientific/Regulatory Affairs discipline.

2. Proven industry experience in EU Regulatory Affairs and Orphan drug products.

3. A working knowledge and practical experience with working in an EU and/or Global Regulatory Affairs team, Orphan products experience is an advantage.

Key Words: Regulatory Affairs / RA / Reg Affairs / RA Specialist / RA Contractor / RA Consultant / RA Scientist / Regulatory Affairs Specialist / Regulatory Affairs Contractor / Regulatory Affairs Consultant / Regulatory Affairs / Scientist / Orphan Drug Designation / Orphan Drug Products / BioPharmaceutical / Pharmaceutical / Biologics / Remote / MAA / MA / Marketing Authorisation / eCTD / EU Regulatory Affairs / Global Regulatory Affairs

Interested in this job? Apply for this position now!

Your Recruitment Consultant:

Fabio Roque

*Disclaimer*

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.

Sectors: Pharmaceutical, Medical Device

Skills: Regulatory Affairs - Contract, Regulatory Affairs - EU, Regulatory Affairs - UK, Regulatory Affairs - Global, Regulatory Affairs - Operations, Regulatory Affairs - Medical Device, Regulatory Affairs - Registrations

Share this job:

Other jobs with similar skills

Hyper Recruitment Solutions

HRS Headquarters
Hyper Recruitment Solutions
3rd Floor, Crown House
151 High Rd, Loughton, Essex
IG10 4LF

HRS Registered Office
Hyper Recruitment Solutions
Amshold House, Goldings Hill
Loughton, Essex
IG10 2RW

HRS Manchester
Hyper Recruitment Solutions
Bounds Building, 68 Sackville Street
Manchester, Greater Manchester
M1 3NJ

HRS Scotland
Hyper Recruitment Solutions
92-98 Fountainbridge
1 Lochrin Square, Edinburgh
EH3 9QA

Keep up with us!

Got any questions? Email us at:

| |

\xc2\xa9 Copyright Hyper Recruitment Solutions 2023 | All rights reserved | Registration Number: 07747824

Hyper Recruitment Solutions