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Job Details

Senior Regulatory Affairs Manager

Company: Regulatory Professionals
Location: London
Reference: JO-1804-406611
Closing Date: 20 May 18
Type: Full Time
Salary (£): 0 - 20,000
Benefits:

Job Summary:

Regulatory Professionals are collaborating with a global bio-pharmaceutical company with a strong pipeline including treatments for cancer, HIV and respiratory diseases

Requirements:

Senior Regulatory Affairs Manager
Central London
Competitive salary and benefits package
Job Reference: JO-1804-406611

Regulatory Professionals are collaborating with a global bio-pharmaceutical company with a strong pipeline including treatments for cancer, HIV and respiratory diseases. With a rapidly expanding portfolio, this client is looking for a Senior Regulatory Affairs Manager to come on board to provide Regulatory expertise on CTA submissions for UK and Irish affiliates.

Key Responsibilities:
- Liaise with MHRA/ HPRA to build and maintain contact with personnel.
- Compile and submit Clinical Trial Applications, amendments and other applicable Clinical Trial submissions.
- Adhere to ABPI code of practice as well as ensuring compliance to GMP and GDP.
- Provide Regulatory product strategy when required.
- Share knowledge on national scientific advice and requirements.
- Further submissions may include safety reports, amendments, supplements and license renewals for Clinical Trial Applications and Marketing Authorisations.

The ideal candidate will possess the following skills:
- Extensive experience in liaising with the MHRA and HPRA.
- Working knowledge of compiling and submitting Clinical Trial Applications and amendments.
- A minimum of 8 years experience in a Regulatory role and strong understanding of pharmaceutical / Bio-tech industries.
- Ability to integrate well into a small team and work collaboratively with colleagues on other sites.
- Line management potential is desirable for future progression, but not essential.

If you meet the outlined requirements and are interested in this position then please feel free to send your CV to josie@regulatoryprofessionals.com or if you have any questions regarding the role then please call 01189 522 797.
If this role is not quite right for you, but youre interested in hearing about new career opportunities, then please still get in touch as further Regulatory roles are available. Additionally, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if successfully placed youll receive 250 worth of vouchers.

Apply for this job: Senior Regulatory Affairs Manager

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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