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

Main tasks

• 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

Key Competencies

• 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 michelle@stelfoxuk.com

With over 7 years experience in recruitment and outsourcing Michelle specialises in Regulatory Affairs for the pharmaceutical industry.
Stelfox - 13 months ago