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Regulatory Affairs Scientist (12 FTC)

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Description

Are you looking to take your career to the next level?


We are looking for a Regulatory Affairs Manager to join our P&G Personal Healthcare division based in Darmstadt, on a fixed-term contract of 12 months. This role will be responsible for independently performing regulatory activities in order to support successful local approvals and maintaining Marketing Authorisations in Germany. You will be the Regulatory business partner for our business and will support promotional activities, as well as innovation projects, and ensure compliance of our unique medicinal products to market regulations & guidelines as well as to P&G standards.


With us you will:

  • Have full responsibility for the preparation of regulatory submissions across our portfolio of medicinal products

  • Identify, develop and implement the regulatory strategy regarding local Life Cycle Management and local registration of new products, in conformance with Electronic Common Technical Document standard (eCTD)

  • Review product artwork and promotional material ensuring compliance with the marketing code and legal requirements

  • Advise the organisation of potential regulatory risks in normal day to day activities and recommend compliant actions

  • Develop and maintain positive relationships with our key external partners, such as; health authorities, distributors, regulatory authorities, trade associations and contract manufacturers


Qualifications

Apply if you have:

  • A Master’s degree in; pharmacy, medical, veterinary or other health-related science
  • In-depth technical regulatory knowledge and experience regarding EU and national requirements for over the counter & Rx medicinal products.
  • Consistent track record in getting registrations/variations approved in Germany
  • Excellent English & German communication skills (both oral and written), able to communicate effectively to convey complex technical information to regional / global area experts, and discuss / present expert matters confidently

What we offer:


Responsibilities as of day 1. You will have project ownership and autonomy to deliver change and results from the beginning. Dynamic and encouraging work environment.


At P&G our employees are at the core, we value every individual and encourage initiatives, promoting agility and work/life balance.


Continuous mentoring, you will work with passionate people and receive ongoing coaching and mentoring from your line manager and other colleagues. Corporate and functional training will enable you to succeed and develop from day one.


Good to know:


We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of race, colour, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, HIV/AIDS status, or any other legally protected factor. Our people are all equally hardworking in outstanding ways: we come from diverse traditions, personal experiences and points of view. And we want to include yours.



Job locations:
Darmstadt, Hesse, Germany
Job Type: Full-time Req No: RND00004338
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