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Regulatory Affairs Manager Latam
3 semanas atrás
Work Your Magic with us
Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
**Your role**:
As a Regulatory Affairs Manager LATAM you will be dedicated to support one of our Life Science Division, being responsible for assigned portfolio products, planning and executing regulatory activities supporting the implementation portfolio expansion, working in collaboration with global/ regional functions and stakeholders across the region and the globe providing strategic and functional inputs to the LATAM team.
- Interfaces cross-functionally within RA, as well as with Commercial, Global Marketing, etc. to identify what LATAM requirements will impact the strategy and how to best move forward to meet project plans focused in Bioprocess, Novel therapy, Vaccines, API and Excipients;
- Provide LATAM regulatory intelligence to product teams;
- Responsible for LATAM strategic input for assigned products supporting the expansion of portfolio;
- Interface and Communications with Regulatory Authorities to facilitate productive dialogue on assigned products and detect regulatory trends and influence positively regulatory discussions;
- Regulatory surveillance not only for regulations that impact Merck, but also for regulations that impact our customers for communication purposes;
- Support with customer guidance, including presence at customer meetings and/or events for customers;
- Provide Training sessions to support the commercial team understand the regulatory environment, improving their interactions with customers;
- Support to develop procedures to address local regulatory needs that are not covered by global procedures (Bioprocess, DMF requirements for the region, leachable and extractables discussions, food additives requirements, Biodiversity regulations);
- Provide expert advice to ensure proper evaluation of regulations applicable to products and services provided or under development for Merck;
- Answers costumer’s questions for products portfolio received through our customer services department; Support the launch of products, offering a regulatory assessment for the commercial team in region;
**You are**:
A team worker with the ability to influence in order to achieve objectives. You will have excellent organizational skills, flexibility and attention to detail along with a mind-set towards adherence to timelines. To enable success in this position you will have:
- A degree in pharmacy/life sciences or similar
- Direct experience in LATAM markets Regulatory Affairs
- Experience of interactions with Regulatory Authorities
- Proven knowledge to provide strategic regulatory guidance on Bioprocess, Vaccine and Life Science Fluent in English and Spanish
**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress
