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Regulatory Affairs Manager – Regulatory Life Cycle Management
Senior Regulatory Affairs Manager - EU
Vitamin Food supplements & Medicinal products
Location: Darmstadt, Germany
Are you looking to take your career to the next level?
The Personal Health Care International (PHCI) strategic priorities includes four core categories of products with both Global Brand Franchises and Regional Product Portfolios across Nerve Care, Pain, Vitamins and Cough & Cold and Digestive.
We are looking for a competent Senior Regulatory Affairs Manager who is eager to take on a new challenge. You will join a large, complex, matrix organization and sit within The Global Regulatory Life Cycle Management Team, acting as the regulatory representative for the EU regional initiatives as well as a strategic business partner to grow brands with focus on Vitamin, Food Supplement & Medicinal products in Europe.
“Do something that matters!”
With us you will:
- Coordinate Regulatory Life Cycle Management activities for Vitamin & Sleep Brands - Focused on food supplements and Medicinal products across multiple countries within and outside Europe
- Lead and coordinate with Local Regulatory Affairs for roll outs (expansions to new markets), variations, renewals, answering health authority requests
- Maintain Global Master Dossiers as well as compile, review, and provide dossiers for local registration and compliance to achieve registrations for the specific product portfolio
- Provide Regulatory input for Periodic Safety Update Reports (PSURs), Product Quality Reports (PQRs) and Product Data Sheets. In addition, Provide strategic regulatory input into Global Product labelling and approval to enable commercial activation of product launches
- Ensure that the Regulatory Information Management system is maintained and advise organization of potential regulatory risks - Proactively recommend compliant actions
- Regulatory assessments are conducted for change controls in the Quality Tracking system
Apply if you have:
- A Minimum of a Master’s degree – Consumer Healthcare / Nutrition Related
- Fluent English – Additional German is a bonus
- Proven experience in Europe Regulations
- Food supplements, Medicinal product & OTC (Over the counter) topic experience
- The ability coach junior colleagues and ensure the management of internal and external resources
What can we offer you?
At P&G, Day 1 starts with you making an impact on the world, P&G brands and your career.
You’ll be at the core of Regulatory Life Cycle Management activities, lead initiatives and take ownership and responsibility of regulatory assessment for changes of our products.
We will offer you world-class training and development to help you become a leader in your field. And it’s not just about what you will do, but how we will make you feel: encouraged, valued, purposeful, challenged, heard, and confident.
You can also expect:
- Flexible working arrangements.
- P&G Vibrant Living programs.
- Competitive salary and benefits package (Private health care, PG stock, saving plans).
- Genuine opportunity to develop within a Top Employer of choice organisation.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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