Regulatory Affairs Officer

Location
West Sussex
Salary
Competitive
Posted
16 Oct 2018
Closes
13 Nov 2018
Ref
J563081
Contact
Aliyah Iheanacho
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions are currently looking for a Regulatory Affairs Officer to join a leading Biopharmaceutical company based in the West Sussex area. In this position you will work as part of a multidisciplinary Regulatory Affairs team where you will get the opportunity to work on both Pre- and Post- Approval projects involving immunotherapy products.

KEY DUTIES AND RESPONSIBILITIES:

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

1. You will prepare and review Marketing Authorisation Applications (MAA) for new products and maintain documentation from Regulatory Authorities.

2. You will ensure the life cycle maintenance of existing products through activities such as annual updates and variations including compiling of Type II, IB and IA variations to National Marketing Authorisations held throughout the EU.

3. Review and approve Clinical Trial Applications (CTA) and Investigational New Drug (IND) submissions.

4. You will be responsible for the preparation and submission of Site Master File, Facilities Licences and the annual TSE report.

ROLE REQUIREMENTS:

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

1. Relevant degree in a scientific discipline (e.g. Pharmacology, Pharmaceutical Sciences, Biology, Biotechnology etc.) in addition to industry experience.

2. Proven experience in a Regulatory Affairs environment, ideally with exposure to CTA / IND documentation or New Product Dossiers.

3. Exposure to SmPC, PIL or CMC documentation in eCTD format will be beneficial to your application but not required, as well as a good working knowledge of GMP regulations.

Key Words: Regulatory Affairs | Regulatory | RA | Officer | Associate | Assistant | Biologics | Biopharmaceutical | Immunotherapy | MAA | CTA | Clinical Trial Application | IND | FDA | eCTD | National Procedures | SmPC | SPC | PIL | CMC | GMP | RTQ | RFI | Variations | Life Cycle Maintenance

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to 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 scientists supporting science. We look forward to helping you with your next career moves.

Similar jobs

Similar jobs