Regulatory Affairs Manager

Full/Part Time: Full Time

Location: Mexico, Brazil

Business Context

Established in 2018, Unilever’s US-centric Health & Wellbeing business is a collective of fast-growing, science-backed companies powering a lifestyle of wellbeing designed for a lifetime of possibilities. Comprised of Liquid I.V., Nutrafol, OLLY, Onnit, SmartyPants, Welly and Equilibra (in Italy), the Health & Wellbeing Collective operates with a start-up mindset and is supporting consumers on their proactive wellbeing journey by bringing innovative products to the market.

Unilever identified Health & Wellbeing as a key growth space for the future and has built the business through a clear M&A criteria and growth strategy to €1bn+ turnover, delivering double-digit, volume-led growth quarter after quarter.

You will be part of the International Expansion team which is responsible for launching H&W’s brands across the world. This cross functional team has end to end responsibility for international expansion of the brands in a fast-paced environment. If you are excited about the prospect of bringing disruptive brands across the world this role is for you.

Role Details Overview: We are looking to recruit an RA Manager for Health & Wellbeing to co-ordinate and drive the international expansion Vitamins, Minerals and Supplements (“VMS”) brands within Health & Wellbeing business. This is a key role that will support the brand teams with the successful expansion of several existing US VMS brands into new markets, with specific focus on South America.

Previous experience of working in VMS and of working with multiple stakeholders in LatAm region, including authorities and trade associations, and functions, including regulatory, R&D, legal, safety, quality and public affairs is essential.

Given the varied legal and regulatory frameworks for VMS, the successful applicant will have a regulatory background in VMS, or a proven track record of leading and supporting VMS businesses in South America. The candidate will need to be familiar with the different product classifications for VMS across food, food supplement, and drug, and a detailed knowledge of the relevant product licenses and notification/ registration requirements in South America, and additional knowledge in international markets is desirable although not mandatory. Candidates who can speak to the theory but who have not got the practical experience or application may not be taken into consideration.

The candidate’s expertise will be focused on our top projects from a challenge and risk perspective to enable cutting-edge innovation and competitive business growth in South America.

We are looking to you as a leader to ensure creativity, agility, speed to market and at the same time rigor to our innovation and compliance processes, in relation to the regulatory aspects. You will be a proactive spark that inspires the business and drive H&W to success in LatAm region.

You will work on interpretation of South America food/ food supplement/ medicine Regulatory frameworks, in order to identify the best route to market for the H&W business and continuous growth.

You will also lead Regulatory Affairs Advocacy topics for H&W in the ever-changing regulatory environment in South America.

Externally, you will be able to represent Unilever in some external fora, such as Local and Regional Trade Associations, Scientific entities or coalitions, on specific subjects according to H&W Agenda.

Internally, you will represent HBrazil B&W Regulatory Affairs in relevant fora, working closely with R&D, Legal and QA, as well as with SEAC, SC and Marketing.

You will report into Dr Sara Sibilla, H&W Head of Regulatory Affairs for Europe and International Expansion and will be based in Mexico or Brazil (Unilever Office TBC) with global cross-functional interactions.

Job Description: The successful candidate will co-ordinate the know-how and roll-out of VMS products in South America. Working together with internal or external stakeholders, the candidate will be responsible for the following activities.

Driving detailed business understanding on the different product notification/registration requirements for VMS in South America countries (and international markets outside South America as desirable but not mandatory). Specifically, the candidate will be responsible for:

• regulatory landscape overview and regulatory management of VMS products;
• formulation, ingredients, raw materials, product specifications and claims review;
• review and approve packaging and marketing materials to comply with local regulations;
• support with product notification/ registration (dossier preparation for product notification), stability and shelf-life considerations, labelling requirements;
• liaise with internal stakeholders and authorities' officers to ensure quick and quality submission dossier for notification.

Pro-actively leading the review, impact-assessment and implementation of all applicable regulations and legal requirements (domestic market and exports) operating as a key internal subject matter expert.

Leading the reviewing and interpretation of local new and proposed rules, regulations and enforcement activities impacting the use of ingredients, safety, labeling and advertising, which may have significant impact on planned business actions and/ or proposals.

Ensuring relevant regulatory risk assessments are communicated to relevant functional experts to inform strategy on ingredients, formulations, and any advertising, brand promotion and communication.

Working cross-functionally with internal stakeholders at global and local level to ensure business objectives are met through strong regulatory strategy and partnership.

Directing the activities of external regulatory consultants who may be required as subject matter experts on specific key programs or activities.

Ensure local regulatory compliance (product license renewal, etc…) in liaison with local regulations and corporate policies, global procedures and multifunction team as directed.

Answer customer enquiries and provide best in class solution as required.

Be in direct contact with the local Health Authorities and trade associations. Conduct regulatory activities as requested, based on business needs.

Key skill, attributes and Experience

• 5+ years of experience in the field of VMS/ consumer healthcare products including cross-functional interactions, technical leadership is essential.
• Bachelor/Master degree holder in health-related science, Life Science, Regulatory Science, Food Science and Technology; Pharmacy or Medical degree desirable.
• Knowledge of LatAm regulations and VMS requirements as well as strong understanding of technical regulation (testing and specification) and GMP, GCP, HACCP are required.
• Ability to assess regulatory risks and opportunities and the impact these may have on the existing and innovation portfolio.
• Thorough understanding of workflow management, project management, multitasking and managing shifting priorities is required.
• Knowledge across a wide range of product categories (food/ food supplements/medicines) including manufacturing and technical systems is required.
• Ability to identify process improvement opportunities to achieve improved, more consistent results and shorter development times is required.
• R&D knowledge would be desirable, as well experience in Project Management and Digital Tools.
• Proven facilitation skills, with multitasking and problem-solving attitude.
• Excellent communication, presentation, and organizational skills, in both spoken and written English, and strong influencing skills. Multi-language speaker is desirable.
• Strong Team mindset. Ability to collaborate with multiple stakeholders both internally and externally at a global level.
• Self-motivated & self-starter, proactive and with a high level of initiative and persistence, with a hands-on approach and result-oriented mindset.
• Enterpreneurial approach and business acumen is required, with a track record of providing solutions and thinking out of the box.
• Strong execution capabilities with ability to handle multiple assignments and manage major projects to successful completion.
• Team leadership: experience in a combined global and local team dynamic across all functions.

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