Regulatory Affairs Manager (Human Medicine And Biologicals)

Hire Resolve is seeking a knowledgeable and experienced Regulatory Affairs Manager specializing in Human Medicine and Biologicals to join our client's dynamic team.
In this role, you will be responsible for managing the regulatory submissions and compliance of pharmaceutical products and ensuring adherence to local and international regulations.
Key Responsibilities: Lead and oversee all regulatory affairs activities related to human medicine and biologicals.
Develop and implement regulatory strategies to ensure compliance with relevant health authority regulations.
Prepare and submit documentation for regulatory approvals, including product registrations and license applications.
Coordinate and liaise with regulatory authorities regarding submissions and queries.
Review product labeling, advertising materials, and promotional content for compliance with regulations.
Ensure ongoing compliance with post-market surveillance requirements and reporting obligations.
Provide regulatory training and support to cross-functional teams.
Conduct regulatory impact assessments for product changes and maintain product dossiers.
Stay current with changes in applicable regulations, guidelines, and industry standards.
Requirements B. Pharm (Bachelor of Pharmacy) and registration with the South African Pharmacy Council (SAPC) Minimum 10 years' experience in Regulatory Affairs with human medicine and biologicals experience Skills: Product registration and dossier maintenance.
Pharmacovigilance experience and knowledge of SAHPRA submission portals.
Launch procedures for new products QA processes, APQRs, customer complaints.
Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa Microsoft Office Suite proficiency.
Familiarity with ZAZIBONA processes and eCTD submissions Benefits Family Leave (Maternity, Paternity) Paid Time Off (PTO) (if applicable) Contact Hire Resolve for your next career-changing move.
Salary: negotiable.
Our client is offering a highly competitive salary for this role based on experience.
Apply for this role today, contact Miné Roux at Hire Resolve or on LinkedIn You can also visit the Hire Resolve website:  hireresolve.us  or email us your CV:   ****** Alternatively, apply via our portal and email ******   We will contact you telephonically in 3 days should you be suitable for this vacancy.
If you are not suitable, we will put your CV on file and contact you regarding any future vacancies that arise.