Senior Regulatory Affairs Associate

Recruiter
SRG Clinical
Location
Cambridgeshire
Posted
02 Feb 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
The Role:Working within Global Regulatory Affairs you will be responsible for submitting regulatory submissions as well as working on obtaining approval of regulatory submissions through interactive communication with Global Health Authorities for investigational and/or marketed drug products. Responsibilities:Review and prepare routine regulatory submissions (e.g., investigator submissions, correspondence to Health Authorities, etc.) as well as supports senior-level staff in the preparation, QC, and submissions of major submissions (initial CTAs/INDs, MAAs/NDAs, Orphan Drug designations, PIPs, variations, and supplements) for investigational and/or marketed drug products. Maintain trackers and electronic files.Develop initial draft and work with Supervisor to develop regulatory strategy on preclinical, clinical and/or CMC issuesRegulatory Intelligence (research regulations, guidance, precedence) responsibilities as assigned by Supervisor.Coordinate and support the team in planning and preparation for Health Authority meetings or teleconference.Experience / QualificationsPharmD, B.Sc. or Master’s degree qualifiedHands on Regulatory Affairs experience in new drug regulated product strategy and submissions; including working knowledge of Health Authority regulations and guidance for new drugs.Strong understanding of regulations/guidelines governing development of pharmaceuticals.Able to challenge the status quo to achieve continuous improvement. If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

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