Senior Regulatory Affairs Pharmacist

About the Role

This 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.

Requirements

• 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.