Regulatory Affairs Manager CMC & Compliance
Stelfox - England
A great opportunity has arisen for you to join the Regulatory Affairs Department at a vibrant and dynamic organisation.
I am looking for enthusiastic and motivated individual to join this team, reporting to the Director of CMC and Compliance. You will take responsibility for CMC and Compliance activities and provide advice and information to the Regulatory Affairs Team Leaders; internal departments, Associated Companies and Licences.
Location: Cambridge (UK) / Germany
Deciding the strategy to address any CMC specific questions from Regulatory Agencies, Associate Companies
Participating in and leading interdisciplinary project teams, and providing guidance in areas of expertise for both research and marketed products
Assisting with the maintenance of all MA's via renewals and variations by preparing the required documents
Building and maintaining relationships internally and externally
Evaluating the impact of new regulations to undertake appropriate actions
Planning and managing the generation of all information/documentation to support regulatory submissions, renewals and variations within project timelines
Qualified degree level in a scientific subject or equivalent, or HND or equivalent industry experience where appropriate
Excellent Knowledge of technical and scientific information, legislation and relevant Regulatory Guidelines
Previous regulatory experience
High attention to accuracy and detail
Fluent in English and good knowledge of German
My client can offer you a challenging position with good career prospects, a self-directed and team oriented work environment, internal and external further education possibilities, an attractive salary as well as excellent social benefits. This position is also suitable to severely disabled applicants who possess all the qualifications outlined above.
If you are highly motivated, committed and looking for your next career move call me without delay for a further discussion, I look forward to hearing from you.
Michelle Jackson (Regulatory Affairs Consultant) + 44 1273 727 930 alternately you can email firstname.lastname@example.org
With over 7 years experience in recruitment and outsourcing Michelle specialises in Regulatory Affairs for the pharmaceutical industry. Stelfox - 13 months ago