Regulatory Affairs Manager (Human Medicine and Biologicals)

Overview

The Regulatory Affairs Manager for Human Medicine and Biologicals will be responsible for ensuring compliance with all regulatory requirements for the development, registration, and marketing of pharmaceutical products and biologicals. This role will involve working closely with internal cross-functional teams, as well as external regulatory agencies, to obtain and maintain product registrations and approvals.

1. Develop and implement regulatory strategies to ensure timely and successful product registrations and approvals for pharmaceutical products and biologicals.
2. Interpret and apply regulatory requirements for the development, registration, and marketing of human medicines and biologicals.
3. Prepare and submit regulatory submissions, including but not limited to new drug applications, variations, renewals, and responses to regulatory inquiries.
4. Maintain an awareness of changes in regulatory requirements and industry trends, and ensure that the organization is in compliance with all relevant regulations.
5. Liaise with regulatory agencies and other external stakeholders to facilitate the regulatory approval process.
6. Provide regulatory guidance and support to internal teams, including clinical development, quality assurance, and manufacturing.
7. Manage regulatory documentation and records in accordance with company and regulatory requirements.
8. Represent the company in regulatory meetings, as necessary.
9. Conduct regulatory assessments and due diligence activities for potential partnerships and acquisitions.
10. Collaborate with global regulatory affairs teams on international product registrations and approvals.

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

• 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

• You can also visit the Hire Resolve website: hireresolve.us or email us your

CV: manufacturing@hireresolve.za.com

suitable, we will put your CV on file and contact you regarding any future vacancies that arise.

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