Manager, Regulatory Affairs
hace 6 meses
The Manager leads the Registration and Regulatory Compliance organization in the Southern Cluster (Argentina, Paraguay, Uruguay, and Chile), providing comprehensive regulatory leadership to the cluster member countries. The Manager drives compliance with all local regulations and corporate standards, and leads the registration strategy across the cluster. Process optimization in daily activities is crucial, ensuring that goals can be achieved with greater synergy and efficiency. This approach provides both speed to market and cost savings for future business growth.
The Manager will build and maintain strong internal and external relationships with key stakeholders, anticipate and proactively resolve emerging issues, and deliver value to the company through regulatory compliance and registration strategies. Teamwork, strong interpersonal relationships, and excellent communication skills are key to this role. Regular collaboration with individuals and business/function leaders is an important asset in this position.
This position reports to the LATAM Registration and Regulatory Compliance Director and belongs to the GSARA (Global Safety Assessment and Regulatory Affairs) organization.
**Main Duties and Responsibilities**
- Deliver value to the company through regulatory compliance and registration advantage. Design, develop, and implement appropriate registration strategies for the Southern Cluster, and communicate outcomes to the business in a timely manner.
- Develop tools and processes to communicate Cluster GSARA requirements to relevant departments and individuals (data, documentation, information). Own GSARA-related processes, systems, and practices in the cluster, constantly generating efficiencies, efficacy, and effectiveness.
- Lead regulatory oversight of major changes in regulations within the Southern Cluster; communicate and coordinate with global/regional GSARA colleagues on implications and implementation of solutions for all countries included in the cluster. Ensure that strategies and activities are aligned across LATAM clusters and other regions and integrated with other parts of the business.
- Engage with and build strong relationships in Regulatory Affairs Committees at key Trade Associations and with Health Authorities. Serve as a company regulatory representative in key technical and regulatory external forums.
**Required Skills / Experience / Competencies**
- Bachelor of Science degree, in a related science (Pharmacy, Chemistry, Biology, Engineering, Science, etc.).
- 5+ years of related experience in regulatory affairs roles, with demonstrated experience in leading people and staff to achieve business results, preferably in the Fast-Moving Consumer Goods industry.
- Ability to speak, understand and write English fluently.
- Strong teamwork, exceptional communication, and interpersonal skills.
- Full-time with the expectation to be available for calls & meetings across time zones.
- Some travel required.
**Inclusion & Diversity**
We’re a global business, with people from every culture, ethnicity, race, religion, gender identity, sexual orientation, age and ability. We recognize the breadth of human experience, and we work to celebrate it. It is our goal to build a diverse, inclusive and supportive work environment where all people can thrive.
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