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Senior Regulatory Affairs Manager – Middle East and EU

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Description
Senior Regulatory Affairs Manager – Middle East and EU
Location: Darmstadt, Germany

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

The Personal Health Care International (PHCI) strategic priorities include 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 knowledgeable Senior Scientist 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 specific global or regional initiatives and as a strategic business partner to grow our global Nerve Care Brands with focus on medicinal products in the Middle East and Europe.

“Do something that matters!”

With us you will:
  • You will act as point contact for our local regulatory colleagues, who manage local markets and authority interactions, as well as with other technical functions, Product Supply, Quality Assurance, Marketing, and manufacturing sites
  • Lead and coordinate Regulatory Life Cycle Management activities within Nerve Care Brand Franchise as well as coordinate with Local Regulatory Affairs for roll outs
  • 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
  • Ensure that the Regulatory Information Management system is maintained and advise organization of potential regulatory risks - Proactively recommend compliant actions
  • Provide regulatory input into Global Product labeling and approval to enable commercial activation of product launches
  • Ensure Regulatory assessments are conducted for change controls in the Quality Tracking system

Qualifications
Apply if you have:
  • A Minimum of a Master’s degree – Ideally Biochemistry, Pharma or Life Science related
  • Fluent English – Additional German is a bonus
  • Proven experience in Middle East and Europe Regulations
  • Medicinal product, OTC (Over The Counter) & Rx (Medical Prescription) 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.

Job locations:
Darmstadt, Hesse, Germany
Job Type: Full-time Job categories: Research & Development Req No: RND00004539
Apply Now

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