Regulatory Scientist

2 weeks ago

Cape Town, Western Cape, South Africa Johnson & Johnson Full time

recruiting for:

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.


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
  • Performs due diligence on clinical/technical data for product acquisitions.
  • Provides consultative support to marketing teams on business decisions with regulatory implications.

Manages Product Portfolio:

  • 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:

  • 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, multidisciplinary 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 indepth 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 wit

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