Regulatory Affairs & Safety Associate/Pharmacist at Reckitt

About the role

• Reckitt is seeking a dedicated Senior Regulatory Affairs & Safety Associate, a role that sits at the core of our innovation process, ensuring that our new product developments meet global regulatory requirements with precision. You will act as a catalyst for change, using your detailed knowledge to create comprehensive dossiers crucial for product registrations. At Reckitt, every individual's contribution is key, and your role will be pivotal in navigating the intricate regulatory landscape to deliver products that enrich lives every day.

The position is for South Africa Regulatory Affairs and Safety. The role encompasses both Health and Hygiene Business Units Regulatory supporting activities including but not limited to:

• Registering pharmaceutical and hygiene products and ensuring compliance under applicable laws and regulations;
• Implementing changes and effect up-dates, compile and maintain regulatory documentation
• Monitoring and interpreting changes in the external regulatory environment;
• Providing drug safety support for new and existing products

Your responsibilities

• Creating and amending registration dossiers as necessary for submission to the regulatory authorities;
• 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 (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 New 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;
• Building beneficial and trusted relations with regulatory authorities, other industry stakeholder and internal Reckitt stakeholders both local and global;
• 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;
• Establish and maintain a database for the payment of various regulatory/ statutory fees;
• Ensure compliance to pharmacovigilance activities and drug safety support executed where needed.

The experience we're looking for

• Degree in a scientific field with a robust understanding of global regulatory environments impacting consumer products.
• Experience in dossier creation, submission, and product lifecycle management.
• A track record of reviewing and authoring high-quality documents.
• Ability to deliver consistently under pressure, adhering to cost, time, and quality standards.
• Familiarity with the regulatory requirements for medical devices in the EU (MDR) and US (510k) would be beneficial.
• Commercially aware, adept at building partnerships and proposing improvements to enhance business processes.
• Bachelor of Pharmacy
• Regulatory experience is a must (Minimum 3 years)
• Ability to understand and interpret regulatory directives and guidelines
• Strong verbal and written communication, and interpersonal skills is essential.
• Analytica skill.
• Results and goal driven
• Self-motivated, confident, proactive and committed to continual improvement.
• Appetite for exploring new and previously uncharted territories