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Job Description - REGULATORY SCIENTIST PHARMACIST (2407020213W)
REGULATORY SCIENTIST PHARMACIST - 2407020213W
Description
Senior Regulatory Affairs Specialist This position reports into Head of Regulatory Operations and is based at Cape town, Western Cape.
Who We Are At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here .
What You Will Do The Senior Regulatory Affairs Specialist has an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements for regulatory submissions, approval pathways and compliance activities and the potential impact of these on business objectives.
Key Responsibilities Regulatory Strategy · Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams.
· Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant.
· Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non-clinical data are consistent with the local regulatory requirements and support the proposed product classification and claims.
· Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
· Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
· Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.
Regulatory Compliance · Maintains awareness of current regulations and anticipates implications and opportunities because of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally.
· Ensures that all products comply with local regulatory and quality system requirements.
· Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions.
· Reviews and approves promotional materials for assigned local Kenvue products and assists in claim support.
· Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
· Ensures that the enterprise Regulatory systems are accurate and fully maintained.
· Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
· Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
· Supports internal and external audits and inspections in collaboration with quality function.
Qualifications
What We Are Looking For · Relevant Bachelor's Degree (B.Pharm) or higher (M.Pharm, Msc. Pharm etc.)
· 6+yrs related regulatory experience.
· Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices
· Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory
solutions throughout the product lifecycle.
· Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
· Leadership and coaching skills with proven experience of people development
· Proficiency in English
For Qualified person (where relevant):
• Be registered member of the South African Pharmacy Council
• Be designated Practising Pharmacist by the Health Authorities
• Knowledge of cGMP, ISO 13485, South African and Sub-Sahara Africa legislation for pharmaceutical, Cosmetics, Foodstuffs and Medical Devices
• Knowledge of production, Quality Assurance, Quality Control, validation.
• At least 2 years of experience as QP deputy
What's In It For You · Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
· Learning & Development Opportunities
· Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location Primary Location Europe/Middle East/Africa-South Africa-Western Cape-Cape Town
Kenvue is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.andEqual Employment Opportunity Posters GINA Supplement.
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