Regulatory Affairs Manager (m/f)

Vertrag | Darmstadt, HESSEN | 7 Monate | Frist: Samstag, 16. Juni 2018, 00:00 Uhr
Diese Position ist abgelaufen. Nicht bewerben!


Excellent & Comprehensive;...


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Job 342 of 1000
Regulatory Affairs Manager (m/f)

Company: Docs Global (Continental Europe)
Location: Darmstadt,Germany
Reference: Ref AS-025396
Closing Date: 16 Jun 18
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

For one of the most successful global players in the pharmaceutical industry DOCS is hiring a Senior Regulatory Affairs Manager (m/f). If you like to challenge yourself with interim projects in the area of regulatory affairs or you are looking to get a foot in the door of one of the top players in the pharmaceutical industry, than this might be for you. The successful candidate will support the national RA team in Germany working on/with text variations, MRP’s,...


Roles & Responsibilities of the position

• Management of all Regulatory Affairs (RA) activities in Germany to meet current and future RA objectives in alignment with the German Regulatory Affairs objectives
• Formulate short and long term vision for local RA function to ensure functional and internal cross-functions alignment
• Support Head of RA Germany to define country specific submission strategies and to implement them locally as per plan
• Act as local RA expert to provide strategic input on the application of local regulations, review processes and submission requirements
• Take ownership for the content of local submission and maintain full awareness of all RA activities on local portfolio, ensuring project deadlines and performance standards are met
• Act as the companies’ representative with local Health Authorities for all regulatory matters

Job Requirements

• Advanced degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) preferred or equivalent
• In-depth technical knowledge of local and EU regulatory requirements and several years of regulatory experience and robust technical regulatory knowledge for medicinal products within Germany and Europe
• Demonstrated ability to recognize business needs and think strategically, with preferred hands-on experience across full development spectrum (early/late/post-market)
• Proven experience in leading Health Authority interactions and negotiations with superior communication and influencing skills
• Excellent English and German language skills (oral and written

Remuneration & other details

• 6 months fix term contract with option for extension (no freelance)
• Full time and office based in Frankfurt/Main area. Home office options can be discussed.
• Top 4 global player in the pharmaceutical industry

Contact Information:
Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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