Regulatory Scientist

Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.
Job Description - Regulatory Scientist (2407019255W)
Regulatory Scientist - 2407019255W
Description
Regulatory Affairs Scientist This position reports into the Regulatory Affairs Manager 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 Regulatory Affairs Scientist provides regulatory support for individual product portfolios, including registration, pre-approval and postapproval activities, in line with the strategic objectives of the Johnson & Johnson Consumer Sub-Sahara Africa cluster and the EMEA Regulatory Affairs organisation.
He/she also ensures that all aspects of Kenvue remain in compliance with the various laws and regulations pertaining to the registration procedures in the markets of the Sub-Sahara Africa cluster.
Key Responsibilities The Roles & Responsibilities include:
· Participates in Regulatory Strategy and business plans
· Understands and interprets the regulatory environment in terms of applicability to the Kenvue business
· Assist with regulatory strategy development for new projects, e.g. new applications, line extensions, reformulations, etc.) for product portfolio.
· Performs due diligence on clinical/technical data for product acquisitions.
· Provides consultative support to marketing teams on business decisions with regulatory implications.
· Effectively manages a portfolio of assigned products in all aspects of Regulatory Affairs and ensures timely completion of activities in line with departmental, regional, and business goals.
· Maintains efficient filing and data indexing systems for all regulatory data and communication in line with compliance requirements.
Registration of New Products/Claims:
· Compiles and submits new product applications or indications for medicinal products, medical devices, complementary medicines and cosmetics to the relevant Regulatory Authorities to achieve timely regulatory approval in line with business goals.
· Conduct document review in order to ensure regulatory quality and scientific integrity of documents submitted to regulatory authorities.
· Monitor follow up and report on progress of regulatory submissions.
Marketed Products:
· Ensures regulatory compliance of marketed products by updating, amending and renewing product licenses as required
· Assists Supply Chain by performing regulatory reviews for Product Quality Reviews/Annual Product Reviews
· Updates and maintain supportive databases to ensure compliance.
Product Labelling:
· Develops draft labelling for registration packages.
· Updates and maintains product labelling in line with corporate and country regulatory agency requirements.
· Reviews and approves artwork relating to product portfolio in line with market regulatory and company requirements.
Advertising and Promotional Material Approval:
· Reviews and approves advertising and promotional material ensuring compliance with country regulatory requirements, marketing guidelines and corporate standards.
· Ensures that agency approval is obtained for advertising material prior to commencement of advertising campaigns in the appropriate countries.
Communication and influencing:
· Interacts and participates in negotiation discussions on regulatory matters with Regulatory Authorities, as appropriate
· Develops and maintains relationships and contacts with key personnel at the Regulatory agencies, key opinion leaders, academics and peers within the industry.
· Actively participates in trade associations to positively influence the regulatory environment.
· Ensures that business is conducted tactfully and professionally and that a favourable company image is created and maintained.
· Develops a network within the Kenvue organization, and effectively interacts at multiple organization levels and with diverse, multi-disciplinary individuals to encourage information flow and dissemination.
· Maintains contact and builds relationships with company subsidiaries and third- party agents in Export Territories.
· Develops, maintains and demonstrates in-depth knowledge of local and major international laws and regulations pertaining to regulatory affairs, and their implications to Kenvue.
· Brings to management attention in a timely manner, any proposed changes in national regulatory laws and procedures where the company has an interest.
· Provides legal, technical and relevant medical information and guidance plus necessary recommendations to the relevant internal and external clients.
· Provides regulatory input and guidance to project teams and departments as required e.g. NPD project teams, Manufacturing Projects, Marketing
Ensures Compliance with Corporate Quality and Regulatory Policies and Procedures:
· Understands and implements relevant Kenvue Corporate Policies and procedures and ensures compliance to relevant Policies, guidelines and legislative requirements.
· Works in close collaboration with regulatory and manufacturing counterparts within the company to ensure the efficient and consistent execution of strategic regulatory plans across Kenvue's portfolio and be accountable for regulatory compliance within the area of responsibilities.
· Participates in regulatory and corporate audits as required.
· Ensures systems, procedures and practices are in place to maintain compliance and adherence to regulatory agency and corporate requirements.
· Ensures company and professional licenses with regards to pharmacy and manufacturing activities are renewed and maintained to ensure compliance with local country regulations.
· Conducts periodic internal audits of regulatory documentation to assess compliance risk and ensure compliance with local, corporate and regulatory agency requirements.
Qualifications
What We Are Looking For Required Qualifications · Relevant bachelor's degree in science or higher.
· 2-3 yrs related regulatory experience.
· Knowledge of consumer healthcare environment and product development
· Understanding of processes and departments within a healthcare company
· Effective time and organisation management
· Proficiency in English
· Excellent oral and written communicator
· Able to work under pressure and to tight time deadlines.
· Able to work under own Initiative.
· Analytical thinker
· Able to work effectively in a multi-cultural, highly matrixed organization.
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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