Regulatory Affairs Manager LATAM: Strategic Expert for Life Science Portfolio
Há 3 dias
We are Merck KGaA, a company that values innovation and science to enrich people's lives. Our solutions span across Healthcare, Life Science, and Electronics, making us a leader in our industry.
As a Regulatory Affairs Manager LATAM, you will be responsible for supporting our Life Science Division, focusing on assigned portfolio products. Your key objectives include planning and executing regulatory activities, collaborating with global/regional functions and stakeholders, and providing strategic inputs to the LATAM team.
This role requires strong interfaces with cross-functional teams, including RA, Commercial, and Global Marketing, to identify LATAM requirements and develop strategies to meet project plans focused on Bioprocess, Novel therapy, Vaccines, API, and Excipients.
You will provide LATAM regulatory intelligence to product teams, support the expansion of the portfolio, and interface with Regulatory Authorities to facilitate productive dialogue on assigned products.
In addition to these responsibilities, you will be responsible for regulatory surveillance, supporting customer guidance, and providing training sessions to improve the commercial team's understanding of the regulatory environment.
To succeed in this position, you will need excellent organizational skills, flexibility, attention to detail, and a mindset towards adherence to timelines.
The ideal candidate will have a degree in pharmacy/life sciences or a similar field, direct experience in LATAM markets Regulatory Affairs, and proven knowledge to provide strategic regulatory guidance on Bioprocess, Vaccine, and Life Science.
Fluency in English and Spanish is also essential for this role.
We offer a competitive salary of $120,000 - $150,000 per year, depending on your level of experience. We believe that everyone deserves access to opportunities for growth and development, and we strive to create an inclusive culture where diverse perspectives thrive.
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