Senior Legal Advisor: Regulatory - Midrand

Job Description

• Dis-Chem Pharmacies in Midrand has an opportunity available for a Senior Legal Advisor: Regulatory to join the Legal team. The main purpose of the role is to provide specialist regulatory legal advice and strategic guidance across the Group, with primary focus on pharmaceutical, pharmacy, medical and healthcare , data protection and privacy, competition law, consumer protection and other applicable regulatory frameworks.
• The role enables compliant, commercially practical business outcomes by identifying and advising on regulatory risk, supporting licensing and regulatory processes , and providing specialist legal input into regulator engagements, investigations, enforcement matters and regulatory disputes.

Minimum Requirements

Essential

• LLB degree or equivalent legal qualification and admission as an Attorney of the High Court of South Africa
• Minimum of 8 - 12 years' post-qualification experience, with substantial regulatory legal experience in healthcare, pharmaceutical, medical, retail, consumer-facing or another highly regulated environment
• Experience in regulator engagements, submissions, licensing investigations, audits, hearings, enforcement or regulatory litigation
• Demonstrable expertise in at least two relevant regulatory areas – across pharmaceutical and healthcare regulation, data protection and privacy, competition law, consumer protection or regulatory litigation – with the ability to advise across unfamiliar regulatory frameworks and providing practical input into commercial, operational, strategic and compliance matters

Advantageous

• Working knowledge of South African pharmacy, medicines, medical, healthcare, data protection, competition and consumer-protection frameworks and relevant regulatory
• Experience in a listed, retail, pharmacy, pharmaceutical , clinic, medical or consumer-facing environment including managing external counsel, technical experts and cross-functional regulatory projects
• Experience with regulatory change management, compliance systems, regulatory reporting or legal technology

Roles & Responsibilities

Regulatory Legal Advisory & Strategy

• Provide authoritative, practical and commercially focused legal advice on pharmaceutical, pharmacy, medicines, medical, healthcare, clinic, data protection, privacy, competition, consumer-protection and other regulatory matters affecting the Group.
• Interpret legislation, regulations, licences, standards, codes, regulatory guidance and enforcement trends, and advise on their implications and application to the Group's activities, products, services and operating models.
• Identify material regulatory risk in proposed business initiatives and recommend proportionate controls, remediation measures or alternative approaches.
• Provide strategic regulatory legal input to support lawful, practical and risk-balanced business decisions.
• Monitor material regulatory developments and translate them into clear legal guidance, implementation priorities, templates and action plans for the Legal team and relevant business functions.

Business-Unit Compliance & Regulatory Processes

• Provide specialist legal input to compliance teams and responsible business owners across the Group, while compliance governance, monitoring, coordination and reporting remain with the relevant business compliance functions.
• Advise on and support licence applications, renewals, registrations, regulatory submissions, approvals, exemptions, permits, certifications and related regulatory requirements and processes.
• Provide legal technical input into regulatory audits, inspections, information requests, reviews, remediation plans and responses to findings.
• Advise on the legal adequacy of compliance frameworks, controls, policies, procedures and remediation plans where specialist regulatory interpretation is required.

Regulatory Engagement, Policy & Proceedings

• Lead or support engagement with relevant regulators and public authorities on legal and policy matters, within approved mandates and in consultation with the General Counsel and relevant executives. • Prepare, review and coordinate legally accurate submissions, representations, responses, briefing materials and supporting records for regulator engagements. • Provide specialist legal input into regulatory inquiries, investigations, audits, hearings, enforcement processes, objections, appeals and other administrative-law processes. • Maintain constructive, credible and appropriately documented relationships with regulators, industry bodies, external advisers and technical experts.

Contracts, Projects & Transactions

• Provide substantive regulatory input into contracts, arrangements and transactions drafted or negotiated by other Senior Legal Advisors , including pharmaceutical, medical, healthcare, technology, digital, data, marketing, distribution, supplier, customer and strategic-partnership arrangements.
• Review and advise on privacy-related contractual provisions, including data-processing agreements, data-sharing arrangements, joint-controller arrangements and international-transfer mechanisms..
• Advise project and transaction teams on regulatory approvals, conditions, notifications, information barriers, competition-law risk, integration requirements and ongoing compliance obligations.
• Develop and maintain specialist regulatory clauses, checklists, playbooks, precedents and guidance for use across the Legal function.

Data Protection & Privacy

• Provide specialist legal advice on POPIA and other applicable data protection and privacy requirements, including lawful processing, direct marketing, data sharing, retention, security safeguards, cross-border transfers and data-subject rights.
• Provide early legal assessment, strategy and specialist regulatory input on threatened or actual regulatory disputes, investigations and enforcement matters.
• Advise on privacy-by-design and privacy-by-default requirements for new projects, products, systems, marketing activities, vendor engagements and operational changes.
• Lead or provide legal input into privacy impact assessments, legitimate-interest assessments, transfer assessments and complex data-subject requests.
• Provide legal advice on actual or suspected personal-information breaches, including risk assessment, notification obligations, regulator and data-subject communications, remediation and lessons learned, under the oversight of the General Counsel as Information Officer.
• Engage with or support engagement with the Information Regulator in relation to inquiries, complaints, investigations, audits, enforcement processes and policy matters.

Competition, Consumer & Other Regulation

• Provide or source specialist competition-law advice on commercial practices, collaborations, distribution models, supplier and customer arrangements, information exchange, market conduct, mergers and interactions with competitors or industry bodies.
• Advise on consumer-protection and marketing regulation, including promotional activity, claims, disclosures, direct marketing, customer terms and regulator engagement.
• Own or coordinate substantive legal analysis of other regulatory matters that do not fall within another Senior Legal Advisors specialist focus area, obtaining external expertise where required.

Regulatory Disputes & Litigation Support

• Provide early legal assessment, strategy and specialist regulatory input on threatened or actual regulatory disputes, investigations and enforcement matters. • Partner with the Senior Legal Advisor : Litigation on regulatory litigation, reviews, appeals and contested regulatory processes, while the Senior Legal Advisor: Litigation retains responsibility for overall litigation strategy and matter management. • Identify and preserve relevant regulatory records, coordinate technical and expert input, and support the preparation of pleadings, evidence, affidavits, submissions and settlement positions. • Advis