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Regulatory Affairs - Scientist in our Innovation Center (m/f)
P&G is made of many individual brands, such as, Pampers, Tide, 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 – formerly known as Product Safety & Regulatory Affairs in Germany). 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.
The team does have global responsibility for projects that are intended to be marketed worldwide.
You are the right fit if you
- have high Academic level education in Pharmacy of Life Sciences
- have German as mother tongue or equivalent fluency
- Fluency in English both written and spoken is a must
- Have already previous working experience of 4-6 years with regulated products (e.g. medicines)
Further requirements for this role are
- Shown ability to rapidly acquire knowledge and understanding of therapeutic categories, analyze scientific and clinical data/information, translate data/information into business relevant language and messaging.
- Ability to work effectively and build superior relationships with external organizations.
- Passion for excellent execution and follow through.
- Strong initiative and follow-through
- Excellent Communication and Presentation skills
The following will be your main tasks
- Run 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).
- Manage all product (Medicines and non – medicines) life cycle, including variations, renewals and other local requirements (ex. Sunset clause if applicable) and ensure full compliance to national/ European regulations, Company standards and SOPs
- Provide Budget estimate for each Fiscal year and keep control of the expenses.
- Interact with Ministry of Health and other Regulatory Authorities for above activities building and fostering a network of contact to facilitate dialogue during regulatory procedure. Represent the MA Holder (MAH) in all matters relevant to medicinal products and other Personal Health products, including regulatory questions, issues and crisis.
- Assume the role of Information Officer (Advertising, packaging/texts) for WICK Pharma pursuant to Sec. 74a AMG (Arzneimittelgesetz) [German Medicines Act]
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, stock purchasing programs, flexible working times, vacation and Christmas bonus, company shop, gym, etc.
Interested? We are looking forward to your online application.
Please share the below listed documents for being considered – no photo required. Feel free to specify your interests in your cover letter.
- CV as a separate document
- Cover letter for the specific role you are applying
- Copy of Bachelor and Master diploma and transcript (if applicable)
- Copy of relevant work, internship and volunteering certificates or reference letters
Please have in mind that individual attachments cannot be larger than 5 MB and you may upload up to 25 attachments. Should some of your files be too large, try to zip them into one Attachment.
If your application is incomplete, please expect major delays in the recruitment process.
You can explore our hiring process here: http://pgcareers.com/apply/our-hiring-process/
P&G is a leading global consumer goods company whose winning brands are built around the model of innovation. Whatever your passion is, we want to ignite your potential to become your very best self. We hold true to our purpose, values and principles as we seek to make a difference in the world around us. You will engage in meaningful work that will touch the lives of others and have a real impact. Everything at P&G starts with understanding - understanding our consumers and our employees as we innovate to improve lives now and for generations to come.
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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