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Regulatory Affairs Manager - Development - Germany
My client - an international medium-sized pharmaceutical company is looking to recruit a Regulatory Affairs Manager to join their team based in the global headquarters in Germany.
To find out more about the company call Nikolay on +44 (0)207 255 6665 or e-mail Nikolay.dimitrov@secpharma.com
Regulatory Affairs Manager – Development – Germany
My client – an international medium-sized pharmaceutical company is looking to recruit a Regulatory Affairs Manager to join their team based in the global headquarters in Germany.
To find out more about the company call Nikolay on +44 (0)207 255 6665 or e-mail Nikolay.dimitrov@secpharma.com
As a Regulatory Affairs Manager – Development, you will be responsible for providing regulatory guidance; developing and implementing regulatory strategies throughout the entire drug development process.
Key Responsibilities:
• Represent Global Regulatory Affairs in cross-functional development project teams
• Be responsible for the overall co-ordination of clinical trial authorizations (CTAs) applications to health authorities worldwide.
• Co-ordinate health authority meetings to obtain e.g.
scientific advice on the proposed further development of a drug product.
• Co-ordinate with the support of a regulatory subteam- the first waves of marketing authorization applications worldwide.
• Have a central liaison function with subsidiaries, external partners and health authorities.
Skills required:
• Familiar with relevant guidelines and aspects of preclinical and clinical research,
• Regulatory Affairs experience gained in pharmaceutical industry or regulatory authority
• University degree in Life Science (pharmacy, biology, chemistry or comparable discipline),
• Very good analytical and strategic thinking ability as well as excellent communication skills,
• Very structured and attention-to-detail working style,
• Business fluent English skills
• Team player who enjoys working in cross-functional and international teams.
Regulatory Affairs Manager; Global Regulatory Affairs; Development; CTA; Germany
Nikolay Dimitrov
Pharmaceutical Division
+44 (0)20 7255 6665
+33 (0)170807489
+49 (0)69 222 22 888
+41 (0)44 580 3717
Email: Nikolay.Dimitrov@secpharma.com
Web: www.secrecruitment.com