Life Cycle Management Specialist – Regulatory Affairs
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.
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, Cough & Cold and Digestive. Products within these portfolios include medicines, food supplements, medical devices, vitamins, health food and cosmetics.
The Global Regulatory Life Cycle Management Team has a fulltime position available to grow and maintain our global Medicinal products). We are looking to hire a candidate strongly interested and basically skilled in Regulatory Affairs, who will lead & coordinate changes to existing products/dossiers, roll-out of existing dossiers to new markets, and day to day changes to our products keeping them on the market.
This opportunity will see you act as the regulatory representative for specific global or regional initiatives for our Medicinal Brands and as a strategic business partner to build bigger and better initiatives with a focus on medicinal products. You will act as point of 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.
- 1. Coordinate Regulatory Life Cycle Management activities for Medicinal products across multiple countries within and outside Europe.
- 2. Coordinate with Local Regulatory Affairs for roll outs (expansions to new markets), variations, renewals, answering health authority requests.
- 3. Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve registrations for the specific product portfolio.
- 4. Provide Regulatory input for Periodic Safety Update Reports (PSURs), Periodic Quality Reports (PQRs), and Product Data Sheets (PDS).
- 5. Advise organization of potential regulatory risks in normal day to day activities and recommend compliant actions.
- 6. Liaise with Corporate Technical and Product Supply functions to provide the current registered details of each product.
- 7. Ensure regulatory assessments are conducted for change controls in the respective Quality Tracking system.
- 8. Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents.
- 9. Provide strategic input into Global Product labelling and approval to enable commercial activation of product launches.
Requirements (skills / experiences) for the role:
- Education: A minimum of a Masters’ degree in Life-Science (food chemistry, food technology, pharmacy, medicine, nutrition, etc.).
- Languages: Proficiency in English.
- Geography: Ability to work permanently in country of residence
- 1. Fresh graduate or professional with initial regulatory affairs experience (0-2 Years), preferably in consumer health and preferably across multiple regulatory classification areas:
- 2. Strong motivation for dossier maintenance and product change management
- 3. Skilled in working with complex Regulatory databases
- 4. Strong initiative and follow-through with accountability for work quality
- 5. Organizational skills and solution-oriented attitude to handle a complex product-country portfolio
- 6. Excellent attention to detail, good communication and presentation skills
- 7. Results oriented and self-motivating with an ability to influence others
- 8. Openness to change and ability to think out of the box
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!
AT P&G #WESEEEQUAL
We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of race, color, 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!