Regulatory Affairs and Compliance Manager - Gauteng, Johannesburg

The Focus Group • Other • Johannesburg, Gauteng, South Africa • $200 - $300 / year • 5h ago

Regulatory Affairs and Compliance Manager - Gauteng, Johannesburg

CLIENT
A well established pharmaceutical multinational in human and animal health, with a strong track record globally and within the EMEA region.

ROLE PURPOSE
We are looking for a Technical and Regulatory Manager based in Johannesburg. This position will be responsible for driving internal and external regulatory compliance for registration and maintenance of CLIENT Animal Health products and ensuring promotional materials are following legislation and relevant codex. Key responsibilities in this role will include ensuring pharmacovigilance and compliance in line with legal and company requirements and providing technical support for assigned products.

This position will be reporting to the Head of Animal Health Southern Africa.

ROLE RESPONSIBILITIES

Ensure timely submission and completion of dossiers to achieve successful registration of new veterinary products in line with local regulatory requirements.
Maintain registration of registered products by providing updates, variations and renewals through timetables and timely payments.
Oversee, check and approve advertising and promotional materials are in compliance with relevant laws, regulations and codex.
Ensure appropriate pharmacovigilance reporting to internal and external functions through system maintenance and technical product knowledge.
Participate and contribute to relevant stakeholder meetings to establish state of the art internal and external regulatory network and knowledge.
Support in registration of new products and registration maintenance for additional Sub-Saharan countries in line with respective portfolio strategies.
Ensure correct and accurate artwork of veterinary packaging that is compliant with the regulatory requirements of the South African and SSA Regulatory Authorities.
Provide technical support for assigned products by providing timely response to customer requests, technical advice and competent training.
Closely collaborate with Quality Control with respect to legal and regulatory requirements for veterinary medicines.

ROLE REQUIREMENTS

Bachelor's degree in Veterinary Medicine or Pharmaceutics/Pharmacist.
Minimum 3 years in Regulatory and PV within the Pharmaceutical industry in South Africa and Sub-Saharan Africa.
Prior experience in handling and managing projects.
Strong scientific and technical knowledge.
Ability to balance an understanding of the business and customer needs.
Flexibility and agility to manage and support changes in the organization and need for continuous improvements.
Excellent interpersonal and communication skills.
Capable of organizing, planning, and prioritizing workload.

Desired Skills: