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Senior Regulatory Affairs Specialist

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Kenvue

17d ago

  • Job
    Full-time
    Senior Level
  • Healthcare
  • Cape Town

AI generated summary

  • You need a relevant degree, 6+ yrs regulatory experience, knowledge of compliance, strong leadership, communication skills, and proficiency in English. Registration as a Pharmacist is essential.
  • You will manage product registrations, ensure compliance with regulations, support product development, prepare submissions, review promotional materials, and facilitate audits while anticipating regulatory changes.

Requirements

  • 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
  • Excellent knowledge of required regulatory frameworks including medicines regulation and/or cosmetic regulation as a minimum within their geographic area of responsibility
  • Strong personal and people leadership, able to coach and develop emerging talent
  • Broad knowledge of consumer healthcare environment and product development
  • Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
  • Strong interpersonal skills; able to build effective personal networks internally and externally.
  • Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
  • Strong organizational and time management skills with an ability to work under pressure.
  • Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced, dynamic, Results-driven environment.
  • Able to work effectively in a multi-cultural, highly matrixed organization
  • Proficiency in English

Responsibilities

  • Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan.
  • Manages the coordination, compilation, submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility.
  • Maintains compliance for all products with local regulations and quality system requirements.
  • 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.
  • 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.

FAQs

What is the job title for this position?

The job title is Senior Regulatory Affairs Specialist.

Where is the position based?

The position is based in Cape Town, South Africa.

Who does the Senior Regulatory Affairs Specialist report to?

The Senior Regulatory Affairs Specialist reports to the Head of Regulatory Operations.

What qualifications are required for this role?

A relevant Bachelor's Degree (B.Pharm) or higher (M.Pharm, Msc. Pharm, etc.) is required, along with 6+ years of related regulatory experience.

What areas of expertise are needed for this position?

Expertise is needed across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities, and/or Medical Devices.

Is proficiency in English necessary for this role?

Yes, proficiency in English is a required qualification.

What are the main responsibilities of the Senior Regulatory Affairs Specialist?

Responsibilities include ensuring the success of product registrations, managing regulatory submissions, maintaining compliance with local regulations, providing regulatory strategy and guidance, and reviewing promotional materials.

Are there any specific compliance responsibilities within the role?

Yes, the role involves maintaining awareness of current regulations, ensuring product compliance, supporting internal and external audits, and reviewing and approving promotional materials.

Is experience as a Qualified Person needed for this position?

Knowledge of cGMP, ISO 13485, and relevant legislation for pharmaceuticals, Cosmetics, Foodstuffs and Medical Devices is preferred, as well as at least 2 years of experience as a QP deputy for those responsibilities.

What benefits are offered for this position?

The position includes a competitive benefit package, paid company holidays, paid vacation, volunteer time, summer Fridays, learning and development opportunities, and access to employee resource groups.

Does Kenvue have an Equal Opportunity Employment policy?

Yes, Kenvue is proud to be an Equal Opportunity Employer and considers all qualified applicants without discrimination.

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Kenvue

A new view of care 🤍

Manufacturing & Electronics
Industry
10,001+
Employees
2023
Founded Year

Mission & Purpose

Kenvue, formerly part of Johnson & Johnson, is a global consumer health company specializing in developing, manufacturing, and marketing trusted brands in personal care, over-the-counter pharmaceuticals, and other health-related products. Their ultimate mission is to enhance the well-being of people around the world by providing high-quality, innovative products that improve health and daily living. Their purpose revolves around empowering consumers to live healthier lives through reliable and effective health solutions.