- 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.
- 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.
Regulatory Affairs Manager - Ciudad de México - Unilever
Descripción
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:
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