Senior Regulatory Affairs Specialist

2 weeks ago

Cape Town, South Africa Johnson & Johnson Full time

Description

Kenvue is currently recruiting for:
**Senior Regulatory Affairs Specialist**

This position reports into the Senior Manager: Regulatory Affairs and is based in Cape Town, South Africa.

**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®, BENYLIN®, 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 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.
- Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan
- Maintains compliance for all products with local regulations and quality system requirements
- 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 as a result 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

Where required, the Senior Regulatory Affairs Specialist may have additional responsibilities including but not limited to:

- Qualified Person
- Responsible Person
- Responsible Pharmacist
- Management & oversight of GMP Inspections and/or
- Compilation & submission of Pricing Applications &/or product reimbursement requests to the relevant national Regulatory authorities

Where Qualified Person:

- Be the representative of the company for the Health Authorities, as responsible Qualified Person.
- Approve and be responsible for all technical documentation related with registration and Marketing Company

authorization.
- Ensure compliance with the authorized specifications of each product.
- Ensure that GMP’s are applied, even if these operations are outsourced to an external manufacturer.
- Approve all Business Quality procedures of the marketing Company.
- Release into the market each batch, once conformity with approved specifications is verified. Formalize this release through appropriate documents, which must be updated and available for auditors. OTC Batch release approvals and batch assignments approvals prepared and issued by Local Business Quality.
- Support the Health Authorities during inspections.
- Manage recall of

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