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Job Details

Senior Regulatory Affairs Manager

Company: Regulatory Professionals
Location: Hertfordshire
Reference: JO-1808-414347_2
Closing Date: 17 Oct 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

This leading global research and development pharmaceutical company is looking for a senior regulatory affairs manager to join their Hertfordshire team.

Requirements:

Senior regulatory affairs manager

Hertfordshire

Permanent

salary: competitive

Reference: JO-1808-414347

This leading global research and development pharmaceutical company is looking for a senior regulatory affairs manager to join their Hertfordshire team. As a senior manager you will be reporting directly to the director of the global and strategy team.

Responsibilities include:
- Guide the CMC-regulatory group as a member of staff.
- Lead the preparation of submission documents (IMPD-Q, Module 3 for MAA or license variations and provide response to questions from health authorities in a timely manner).
- Provide oversight for the CMC components of all regulatory submissions (CTA or IND, NDA or MAA, amendments, variations, scientific advice briefing documents, CMC agency communications etc)
- Engages or leads in CMC sub-teams to plan, prepare and complete the CMC sections of major submissions
- Engages with patients reality socialization human health care (HHC) activities


Candidate responsibilities include:
- Extensive regulatory experience plus additional related experience
- A strong working knowledge of the application of the principles of chemistry to drug synthesis
- Experience dealing with agencies, preparation of briefing documents and holding agency meetings relating to Quality issues.
- Be able to support regulatory strategy and manage timelines to meet project needs
- Experience in leading effective responses to Health Agency CMC questions



If you are interested in discussing this role further then please email your CV to Rauzan.Iqram@regulatoryprofessionals.com or call Rauzan on 01189 522 979 to arrange a confidential discussion.

If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers*terms and conditions apply.

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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