(Pharma) Regulatory Affairs Officer

Performability Recruitment
Cape Town
ZAR 200 000 - 300 000
Job description

A globally renowned cosmetic company is in search of a Regulatory Compliance Officer to partner with R&D, marketing and the likes to ensure international compliance of all products.

Key Performance Areas

  1. Investigates and interprets regulatory and legislative needs globally and summarizes the requirements as per business needs.
  2. Manages and is responsible for the registration of products and supplements globally by initiating, compiling, approving, and submitting the necessary documents to the regulatory body as per requirements.
  3. Sources and summarizes regulatory requirements for new territories.
  4. Initiates and actions change controls on regulatory changes as required.
  5. Prepares and authorizes declarations for AUS shipments.
  6. Ensures international and national legislations are adhered to by reviewing standards versus dossiers as per alert notifications.
  7. Manages the lifecycle of the company product registrations in accordance with legal and regulatory requirements.
  8. Requests product information or declarations from R&D and generates SDS for finished goods, CITIES, and files electronically.
  9. Implements identified actions and regulatory requests as per senior management's evaluation of risk.
  10. Reviews all artwork to ensure regulatory requirements are met globally by using the brand specification sheets provided.
  11. Collaborates with cross-functional teams to ensure regulatory compliance.

Qualifications & Experience

  1. Bachelor of Science qualification or related degree.
  2. 2 - 3 years related regulatory experience in the manufacturing industry.
  3. Cosmetic/Pharmaceutical environment experience.
  4. Excellent written and verbal communication skills.
  5. Attention to detail and organizational skills.
  6. Ability to work independently and on several projects simultaneously.

Salary + benefits (on top of salary)

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