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 management’s 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.
