P&G - Senior Scientist - Regulatory Life Cycle Management (8-10 yrs)
Meaningful work from Day One:
Procter & Gamble is the largest consumer goods company in world! You will be given the opportunity to do meaningful work with important responsibilities from Day 1, build and develop your expertise in one of the best organizations in the world, and benefit from tools and resources that help you enable our people and organizations to perform at their peak. You will join a global community of talented and motivated co-workers who are among the world's best at what they do and you will get to connect our people to P&G's Purpose so they can touch and improve more lives and deliver stronger, more effective business result.
Overall job description:
- The PHCI strategic priorities incudes four core categories of products with both Global Brand Franchises and Regional Product Portfolios across Nerve Care, Pain, Vitamins and Cough & Cold. Products within these portfolios include medicines, food supplements, medical devices, vitamins, health food and cosmetics.
- The Global Regulatory Life Cycle Management Team is looking for an experienced candidate who will lead new initiatives requiring changes to existing products/dossiers, roll-out of existing dossiers to white space, 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 within the VMS Brand Franchise and as a strategic business partner to build bigger and better initiatives with a focus on health supplements. You will act as point contact for our local regulatory colleagues, who manage local market and authority interactions, as well as with other technical functions within MPD, Product Supply, and manufacturing sites.
- Lead and coordinate Life Cycle Management activities within the Vitamins, Minerals & Supplements franchise
- Coordinate with Local Regulatory Affairs for roll outs (expansions untapped opportunities), variations, renewals, answering health authority requests
- Maintain Global Master Dossiers and 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), Periodic Quality Reports (PQRs), and Product Data Sheets (PDS).
- Advise organization of potential regulatory risks in daily activities and recommend compliant actions
- Liaise with Corporate Technical and Product Supply functions to provide the current registered details of each product.
- Ensure regulatory assessments are conducted for change controls in the Quality Tracking system
- Update the Regulatory Information Management System for all activities
- Provide strategic input into Global Product labelling and approval to enable commercial activation of product launches.
- Provide coaching to junior colleagues or new comers to the team and ensure the management of internal and external resources (consultants)
A minimum of Scientific degree in Life-Science (pharmacy, medicine, chemistry, biology, etc.).
Languages: Proficient in English language.
Vendors (contract manufacturers, regulatory consultants)
Global/Regional Multifunctional teams leading Personal Health Care (Manufacturing Sites, Regulatory, R&D, QA, Commercial)
- At least 8-10 years of extensive regulatory experience preferably in consumer health across multiple regulatory classification areas (health supplements, medicines, medical devices, etc.)
- Experience developing regulatory strategies for successful launch of new products & the maintenance of existing products ideally across different countries/geographies within Asia, India, Middle East and Africa
- Proven ability to work independently in a matrix environment to build outstanding relationships with partners
- Strong initiative and follow-through with accountability for work quality
- Excellent attention to detail, communication and presentation skills
- Result oriented and self-motivating with an ability to influence others
- Demonstrated ability to balance competing priorities effectively with excellent organizational skills
- Commercial understanding of corporate and operational business issues
- Openness to change and ability to think out of the box
Just so you know:
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 or any other legally protected factor.
We value flexibility and life balance and we have tools and policies ensuring our people feel part of an inclusive community. 'Vibrant Living' offering on-site includes: Group exercises/ Sports-teams, Canteen, Agile workspace design, Flex-work arrangements possible, external vendor partnerships, etc.
At P&G, we don- t just offer a job, we offer a career with varying assignments and lots of development opportunities, so that we develop our leaders of tomorrow.
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