A leading South African pharmaceutical company in Johannesburg is seeking an experienced and knowledgeable Senior Regulatory Affairs Pharmacist to join their team. The role focuses on managing regulatory activities, overseeing product registrations and lifecycle management, ensuring compliance with SAHPRA requirements, and providing technical guidance and support to the Regulatory Affairs team.About the RoleThis role is suited to an experienced Regulatory Affairs Pharmacist with strong technical knowledge, leadership capabilities, and a solid understanding of pharmaceutical regulatory requirements. The successful candidate will be responsible for managing regulatory submissions, maintaining product registrations, engaging with regulatory authorities, and supporting cross-functional business activities. The duties include, but are not limited to:
Ensure compliance with SAHPRA legislation, the Medicines and Related Substances Act, the Pharmacy Act, and applicable regulatory guidelines.
Compile, review, and submit CTD/eCTD regulatory dossiers for registrations, variations, renewals, and other regulatory applications.
Coordinate responses to SAHPRA queries and deficiency letters within agreed timelines.
Manage product lifecycle activities, including PI/PIL updates, labelling changes, and approved variations.
Maintain accurate regulatory records, submission trackers, and document management systems.
Build and maintain effective relationships with SAHPRA and other regulatory authorities.
Provide regulatory support for new product launches, marketing materials, packaging, and business development activities.
Collaborate with Marketing, Supply Chain, Manufacturing, and New Business Development on regulatory matters.
Mentor and provide technical guidance to Regulatory Affairs team members.
Support workload planning, prioritisation, and departmental objectives.
Monitor submission timelines and identify opportunities to improve regulatory processes, systems, and digital tools.
Identify and escalate regulatory risks and compliance issues where appropriate.
B.Pharm degree and current registration with the South African Pharmacy Council (SAPC).
Minimum of 5 years' Regulatory Affairs experience within the pharmaceutical industry.
Demonstrated experience mentoring, coaching, or leading Regulatory Affairs team members or projects.
Sound knowledge of SAHPRA requirements, CTD/eCTD submissions, and product lifecycle management.
Proven ability to independently compile and submit regulatory dossiers and manage regulatory authority interactions.
Experience with DocuBridge, eCTD, or equivalent regulatory document management systems.
Strong technical regulatory knowledge.
Excellent planning, organisational, and communication skills.
Strong stakeholder management, analytical thinking, and sound judgement.
High levels of accountability and attention to detail.
A collaborative approach and commitment to continuous improvement.
Desired Skills:
Senior Regulatory Affairs Pharmacist
Senior Regulatory Affairs Pharmacist
Senior Regulatory Affairs Pharmacist