Crisis Medical jobs

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.
  
• Advise on the regulatory implications of litigation strategy, remedies, undertakings, consent orders,
  settlements and business remediation.

Regulatory Business Partnership and Advisory:

• Act as the specialist regulatory legal partner to executives, business units, Compliance and control functions across the Group.
• Maintain regulatory matter registers and report material risks, developments,, dependencies, deadlines, regulatory engagements, exposures and costs.
• Provide or source regulatory training and awareness and contribute specialist content to Legal and business learning programmes.
• Manage external counsel and technical advisers on regulatory matters, ensuring appropriate scope, strategy, quality, timelines, costs and performance. .
• Support broader Legal priorities by undertaking appropriate pooled Senior Legal Advisor matters subject to regulatory priorities and capacity.

Regulatory Horizon Scanning, Crisis & Incident Response:

• Monitor emerging regulatory developments and assess their potential impact on the Group’s strategy, operating model, products, services and industry position.
• Translate material regulatory developments into legal implications, risks and recommended actions for Legal and relevant executives.
• Provide horizon-scanning insights to support proactive business planning and regulatory readiness.
• Provide specialist legal and regulatory support during significant incidents, investigations, product or service issues and enforcement matters.
• Coordinate urgent legal input into regulatory responses, stakeholder engagements and remediation plans.
• Advise on regulatory risk and response options to support timely, compliant resolution of significant incidents.

Competencies

• Demonstrates and applies advanced knowledge of relevant regulatory and legal and legal frameworks, including pharmaceutical, healthcare, pharmacy, data protection, privacy, competition and consumer regulation. Keeps abreast of regulatory developments and translates changes into practical implications for the business
  
• Cognitive skills
• Business acumen
• Communication skills
• Interpersonal skills
• Quality orientation
• Self-management skills
• Leadership & management skills
• Technical skills - Demonstrates strong litigation strategy, legal research, drafting, advocacy, evidence
  assessment, dispute resolution, investigation and matter-management skills

Special conditions of employment

• South African citizen
• MIE, clear criminal and credit
• Driver’s license and/or own reliable transport
• Occasional traveling
• May be required to work outside normal office hours where material business, regulatory, transaction or
  litigation deadlines require it
• Employment is subject to Dis-Chem policies, applicable vetting requirements and ongoing compliance with confidentiality, conflicts and professional obligations

Remuneration and benefits

• Market-related salary
• Medical aid
• Provident fund
• Staff account

ONLY SUCCESSFUL APPLICANTS WILL BE CONTACTED. IF YOU HAVEN`T BEEN CONTACTED WITHIN TWO WEEKS AFTER THE CLOSING DATE CONSIDER YOUR APPLICATION AS UNSUCCESSFUL.

Dis-Chem Pharmacies is an equal opportunity employer. Dis-Chem’s approved Employment Equity Plan and Targets will be considered as part of the recruitment process aligned to Dis-Chem’s Employment Equity & Transformation Strategy. Dis-Chem actively supports the recruitment of People with Disabilities.