Life Cycle Management Specialist – Regulatory Affairs

Job description

Description

P&G is aleading global consumer goods company whose winning brands are built around themodel of innovation. Whatever your passion is, we want to ignite your potentialto become your very best self! We hold true to our purpose, values and principlesas we seek to make a difference in the world around us. You will engage inmeaningful work that will touch the lives of others and have a real impact.

The PersonalHealth Care International (PHCI) strategic priorities includes four corecategories of products with both Global Brand Franchises and Regional ProductPortfolios across Nerve Care, Pain, Vitamins, Cough & Cold and Digestive.Products within these portfolios include medicines, food supplements, medicaldevices, vitamins, health food and cosmetics.

The GlobalRegulatory Life Cycle Management Team has a fulltime position available to growand maintain our global Medicinal products). We are looking to hire a candidatestrongly interested and basically skilled in Regulatory Affairs, who will lead& coordinate changes to existing products/dossiers, roll-out of existingdossiers to new markets, and day to day changes to our products keeping them onthe market.

Thisopportunity will see you act as the regulatory representative for specific globalor regional initiatives for our Medicinal Brands and as a strategic businesspartner to build bigger and better initiatives with a focus on medicinalproducts. You will act as point ofcontact for our local regulatory colleagues, who manage local markets andauthority interactions, as well as with other technical functions, ProductSupply, Quality Assurance, Marketing, and manufacturing sites.

KeyResponsibilities:

·  Coordinate Regulatory Life Cycle Managementactivities for Medicinal products across multiple countries within and outsideEurope.
·  Coordinate with Local Regulatory Affairsfor roll outs (expansions to new markets), variations, renewals, answeringhealth authority requests.
·  Maintain Global Master Dossiers andcompile, review, and provide dossiers for local registration and compliance toachieve registrations for the specific product portfolio.
·  Provide Regulatory input for PeriodicSafety Update Reports (PSURs), Periodic Quality Reports (PQRs), and ProductData Sheets (PDS).
·  Advise organization of potential regulatoryrisks in normal day to day activities and recommend compliant actions.
·  Liaise with Corporate Technical and ProductSupply functions to provide the current registered details of each product.
·  Ensure regulatory assessments are conductedfor change controls in the respective Quality Tracking system.
·  Ensure that the Regulatory InformationManagement system is maintained and updated for all activities under roleresponsibility, including review of documents.
·  Provide strategic input into Global Productlabelling and approval to enable commercial activation of product launches.

Qualifications

Requirements(skills / experiences) for the role:


Education: Aminimum 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

JobQualifications:

1. Freshgraduate or professional with initial regulatory affairs experience (0-2 Years),preferably in consumer health and preferably across multiple regulatoryclassification areas:

2. Strongmotivation for dossier maintenance and product change management

3. Skilled inworking with complex Regulatory databases

4. Stronginitiative and follow-through with accountability for work quality

5. Organizationalskills and solution-oriented attitude to handle a complex product-countryportfolio

6. Excellentattention to detail, good communication and presentation skills

7. Resultsoriented and self-motivating with an ability to influence others

8. Openness tochange and ability to think out of the box

What we offer:

Responsibilitiesas of day 1. You will have project ownership and autonomy to deliver change andresults from the beginning. Dynamic and encouraging work environment.

At P&G ouremployees are at the core, we value every individual and encourage initiatives,promoting agility and work/life balance!

AT P&G#WESEEEQUAL

We are anequal opportunity employer and value diversity at our company. We do notdiscriminate 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 legallyprotected factor. Our people are all equally hardworking in outstanding ways:we come from diverse traditions, personal experiences and points of view, andwe want to include yours!

Job locations:
Reading, England, United Kingdom Job Type: Full-time Job categories: Research & Development Req No: RND00004569