Regulatory Affairs Portfolio Manager

Description:

Key Performance Areas (KPA’S)
Regulatory Compliance:

Ensuring products and processes meet all applicable regulations and standards.


Dossier Management including submission and approval

Preparing and submitting regulatory applications, including new product registrations, variations, and post-registration submissions in line with Health Authority requirements, guidelines and government gazettes.


Compliance with GMP and Company Policies

Ensuring compliance with Good Manufacturing Practices (GMP) and company policies and procedures.


Labeling and Documentation

Writing, reviewing and approving product labels, professional and patient information leaflets.
Ensure compliance with the Medicines and Related Substances Act, Pharmacy Act, and other relevant legislation.


Training and Development

Staying informed of changes in legislation and regulatory guidance.
Providing training to other team members on regulatory requirements. Best practice sharing within the team


Approval of Marketing Materials

Ensuring that all promotional and marketing materials comply with the Marketing code.


Data and Documentation Management

Maintain accurate records in regulatory databases and ensure timely updates.
Track submission and approval timelines and monitor regulatory project progress.


Stakeholder Engagement

Serve as the primary contact for regulatory authorities and respond to queries and requests for additional information.
Collaborate cross-functionally with PV, QA, marketing, supply chain, and other teams.
Collaborate with Global Regulatory Affairs colleagues.


Pharmacovigilance Compliance

Ensure that you receive a yearly mandatory Pharmacovigilance (PV) training.
Roles involving direct interaction with customers such as Sales Representatives, Customer Care, and Export functions to report any Adverse Drug Reactions (ADRs) complaints to the PV Compliance Officer within one business day of product complaint occurrence. Refer Pharmacovigilance SOP, ZA-MU 3156-SOP-VI-000120427.

Requirements:

Education: Formal Qualifications
Required Level of Education:
Bachelor of Pharmacy (BPharm) degree and registration with the South African Pharmacy Council (SAPC).

Skills & Experience:

Minimum 5 + years of experience in regulatory affairs within the pharmaceutical industry.
Experience with dealing cross functionally and with global regulatory affairs
Strong knowledge of SAHPRA guidelines and regional regulatory frameworks.
Experience with CTD/eCTD submissions and regulatory software.
Experience with Marketing Code
Experience with artwork component creation, review and approval Excellent attention to detail.