Regulatory Affairs & Safety Associate/Pharmacist

Reckitt Benckiser LLC; Johannesburg; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A global consumer products company is seeking a Senior Regulatory Affairs & Safety Associate in Johannesburg. This role is essential for ensuring compliance with regulatory requirements for new products. Responsibilities include preparing registration dossiers, monitoring regulatory changes, and engaging with authorities. A Bachelor of Pharmacy and at least 3 years of regulatory experience are required. The role offers a chance to significantly impact product development and safety within the organization's health and hygiene sectors.

Benefits

Parental benefits

Employee Assistance Program

Life insurance

Global share plans

Short-term incentives

Qualifications

• Minimum 3 years of regulatory experience required.
• Experience in dossier creation and submission.
• Ability to interpret regulatory directives and guidelines.

Responsibilities

• Create and amend registration dossiers for submissions.
• Monitor and interpret changes in the regulatory environment.
• Interface with regulatory authorities on compliance.

Skills

Dossier writing

Commercial awareness

Regulatory compliance

Analytical skills

Strong communication

Education

Bachelor of Pharmacy

Job description

City: Johannesburg

We are Reckitt

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

Research & Development

In Requlatory Department, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals – all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within Reckitt, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

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 updates, 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
• Analytical skill
• Results and goal driven
• Self‑motivated, confident, proactive and committed to continual improvement

Appetite for exploring new and previously uncharted territories.

The skills for success

Commercial Awareness, Business Partnership, Collaboration, Partnership building, Regulatory, Dossier writing, Collaborator, Product Lifecycle Management, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Objective Setting, Business Strategy.

What we offer

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short‑term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Equality

We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.