Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager Location: Maidenhead Contract: 12 Months / Hybrid 3 days per week onsite Hours: 37.5 hours per weekRates: 80-90p/h Job DescriptionSRG are seeking a regulatory affairs manager for a leading pharmaceutical company based in Maidenhead. For this role you will be working in collaboration with line manager and/or Area Product Lead, is responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. Is responsible for ensuring effective product maintenance and lifecycle management, in line with legal/regulatory requirements and regional business needs. May also support European regulatory strategy for assets in development. Duties and Responsibilities In consultation with line manager and/or Area Product Lead;Provides clear and constructive Europe Region (Area) regulatory input and intelligence to Area and Global Regulatory and Development Project Teams via the Area and/or Global Regulatory Lead (GRL) in accordance with Area and Commercial objectives. Ensure planned drug development activities comply with Area guidelines and if they do not provide a critical analysis of the risks and issues with a remediation proposal.Support global product development strategy(s); outlining options for Scientific Advice/PIP/IMPD, coordinating preparation of briefing packages and co-ordinating and leading agency meeting preparation.Prepare strategy recommendations to glob
Other jobs of interest...

Perform a fresh search...
-
Create your ideal job search criteria by
completing our quick and simple form and
receive daily job alerts tailored to you!