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Regulatory Affairs - Scientist in our Innovation Center (m/f)
P&G is made of many individual brands, such as, Pampers, Head & Shoulders, Gillette, and Oral-B, to name a few. Our brands serve customers in different ways—but all with a focus on making people's lives a little easier.
Some of the best Researchers and Engineers develop our products for billions of consumers: Products of superior quality, Products that are safe for humans and the environment when used as intended and under conditions of foreseeable misuse, Products that are in compliance with regulations in the market place.
Do you want to be one of them?
We are looking for an experienced Senior Scientist in the department Global Product Stewardship (GPS). This department is responsible to ensure that products are safe for consumers as well as the environment and meet regulatory needs around the world.
About 700 people worldwide work in GPS, covering different sub- disciplines of Product Safety and Regulatory Affairs. GPS is part of the R&D community and represents about 10% of this community.
Main responsibilities will be the following:
Management of all regulatory activities needed to obtain Marketing Authorizations (MAs) and other authorizations for all medicinal and non-medicinal products (e.g. medical devices, food supplements, cosmetics).
Support of Portfolio in the assessment of new ideas.
Preparation of the regulatory strategy for product registration with the support of the Central RA team.
Management of all product (Medicines and non – medicines) life cycle, including variations, renewals and other local requirements (ex. Sunset clause if applicable).
Management via Corporate systems of all the activities needed to ensure full compliance of labelling and artworks, according to local/European requirements and Company standards.
Revision and clearance via Corporate systems of advertising materials to ensure full compliance with local/European regulatory requirements, internal data, documentation and processes.
Preparation and submission of all Pricing applications.
Budget estimation for each Fiscal year and tracking of expenses.
Regular contacts with Ministry of Health and other Regulatory Authorities for above activities creating and fostering a network of contact to facilitate dialogue during regulatory procedure. You will be representing the MA Holder (MAH) in all matters relevant to medicinal products and other Personal Health products (e.g. medical devices, food supplements, cosmetics), including regulatory questions, issues and crisis.
Verification of full compliance to national/ European regulations, Company standards and SOPs of all marketed products.
Maintenance of Corporate System and Databases for products information, data and documentation.
Management of any external database required for maintenance of medicinal and non-medicinal products (e.g. MoH databases)
Coordination of any consultancy or outsourced support
Regular update on national and international RA legislation and regulations.
Participation in RA related meetings and execute action points
Help to the local Crisis Management Team when necessary
Representation of P&G in Industry Associations and Technical Working Groups.
Leadership in key Medical and Professional & Technical Affairs activities across PHC brands, including but not limited to: ensuring compliance of all Technical Proof of Claim materials against government and industry regulations; provide the local support to develop of technically strong scientific promotional materials aimed at the healthcare professional (advertising, detailing sales aid, demos, newsletters, slide decks, etc)
You are a good fit if:
You have a Master or a PhD in Life Science or Pharmaceuticals.
You are fluent in French, English and Dutch.
You have 2 years of experience minimum in a similar position
You are able to work effectively and build superior relationships with external stakeholders.
You are proactive and take initiatives.
You have excellent communication and presentation skills.
What you can expect from us
- Meaningful and exciting work from the first day in truly international and multi-functional teams
- Early responsibility
- Training-on-the-job and a large portfolio of personal development opportunities and career perspectives
- Competitive salary and social benefits e.g. company pension plan, flexible working times, discounts on our products, gym, etc.
Good to know : We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status or disability status.
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