Regulatory and Safety Manager

About the role

• We’re looking for a Regulatory Affairs and Safety Manager to lead regulatory and safety activities across our Health and Hygiene business units in South Africa. This role will ensure our products meet applicable regulatory and safety requirements while supporting the business in a constantly evolving regulatory environment. You will facilitate the registration and maintenance of medicines, medical devices and hygiene products, including surface care and pest control; monitor and interpret regulatory developments; provide drug safety support for new and existing products; champion Reckitt’s regulatory priorities through external advocacy; and lead and develop the Regulatory Affairs and Safety team.

Your responsibilities

• Facilitate registration and/or maintenance of medicinal, medical devices, cosmetics, hygiene, in line with local business plan and commercial priorities;
• Ensure the required dossier updates are effected at appropriate, regular intervals, in line with regulatory and internal standards;
• Monitor the regulatory environment, collect and interpret regulatory changes and trends that could potentially impact Reckitt products, policies and procedures;
• Interface with relevant regulatory authorities and industry associations to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production for our products;
• Advise Global Category Growth Organisation (CGO), Global Regulatory and Safety Strategy, Research & Development Product Delivery & Maintenance (R&D PDM), and the business on the regulatory requirements and regulatory impact during the early phases of the Product Development (NPD) process;
• Investigate, innovate and/or generate ways to transform the external regulatory landscape for the benefit of the business;
• Provide regulatory and product expertise in the development and clearance of advertising/promotions and label copy for existing and new products;
• Lead ongoing reputation and relationship building with key regulatory authorities to have a thought leadership and lead the external advocacy for key Reckitt regulatory policies and priorities;
• Development, communication and execution of regulatory science & advocacy strategies for advancing Reckitt growth;
• Ensure the alignment between manufacturing documentation and the latest approved regulatory documents; 
• Manage updates to local database to ensure compliance;
• Manage compliance within the department by ensuring global and local processes, policies, SOPs and working instructions are adhered to;
• Ensure compliance to pharmacovigilance activities with drug safety support executed where needed.
• Manage and develop the RAS team with an enterprise mindset, influence behaviour where personal ownership, strong teamwork and care for colleagues are key. 

The experience we're looking for

• Bachelor of Pharmacy (B Pharm); Bachelor of Science (BSc) or equivalent
• Experience in Pharmaceutical and/or FMCG industry regulatory affairs (Minimum 5 years)
• Ability to understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders.
• Proven experience in management and development of people (Minimum 5 years)
• Strategic mindset with demonstrated ability to anticipate future trends accurately and a clear and logical thinker with the ability to recognize patterns and develop innovative solutions

The skills for success

• Business Strategy, Task Execution Under Pressure, Makes strategic Business Decisions, Business accumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, Creative Direction, R&D, Change Leadership, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Relationship Management, Adapt to changes in technological development plans, People Management, People Development, Regulatory, Safety, Risk and compliance.