Senior Regulatory Affairs Associate

Job Type:
Permanent
Job Sector:
Scientific
Region:
South East
Location:
West Sussex
Salary Description:
Competitive
Posted:
22/10/2018
Recruiter:
Hyper Recruitment Solutions
Job Ref:
J563082

We are currently looking for a Senior Regulatory Affairs Associate to join a leading Biopharmaceutical company based in the South East of the UK. In this position you will work as part of a multidisciplinary Regulatory Affairs team where you will lead both Pre- and Post- Approval projects involving immunotherapy products.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior Regulatory Affairs Associate 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 Senior Regulatory Affairs Associate 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 a number of years experience working in Regulatory Affairs.

2. Proven experience working across all area of Regulatory Affairs including but not limited to preparation of MAA submissions, writing of a range of modules (e.g. Module 3 / CMC, Module 2, Non-Clinical and Clinical Modules), management of product variations and renewals as well as CTA / IND submissions for new clinical trials.

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.

Contact Details:
Hyper Recruitment Solutions
Tel: 0203 910 2980
Contact: Georgia Walden
Email:

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