Senior Regulatory Affairs Pharmacist at Hire Resolve

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.