Senior Regulatory Affairs Manager
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.