Senior Regulatory Affairs Manager

Recruiter
Regulatory Professionals
Location
Hertfordshire
Posted
10 Oct 2018
Closes
14 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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.

Similar jobs

Similar jobs