Regulatory Affairs Officer
4 weeks ago
Our client is seeking a Regulatory Affairs Officer to join their team.
Responsibilities:
- Investigates and interpret regulatory and legislative needs globally and sum-ups the requirements as per business needs.
- Manages and 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.
- Sources and summaries regulatory requirements for new territories.
- Initiates and actions Change controls on regulatory changes as required.
- Prepares and authorizes declarations for AUS shipments.
- Ensures international and national legislations are adhered to by reviewing standards versus dossiers as per alert notifications.
- Manages the lifecycle of the company product registrations in accordance with Legal and Regulatory requirements.
- Requests product information or declarations from R&D and generates SDS for finished goods, CITIES, and files electronically.
- Implements identified actions and regulatory request as per senior managements evaluation of risk.
- Review all artwork to ensure regulatory requirements are met globally by using the Brand specification sheets provided.
- Collaborate with cross-functional teams to ensure regulatory compliance.
Skills:
- Excellent written and verbal communication skills.
- Attention to detail and organizational skills.
- Ability to work independently and on several projects simultaneously.
- Computer Literacy.
Qualifications:
- Bachelor of Science qualification or related degree.
- 2 - 3 years related regulatory experience in manufacturing industry.
- Cosmetic/Pharmaceutical environment experience.
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