Senior Regulatory Affairs Manager – Merck Life Science
Join us to innovate with science and technology to enrich people’s lives. We look for curious minds to imagine the unimaginable with us.
Your Role
- Support a Life Science Division by managing regulatory activities for assigned portfolio products.
- Plan and execute regulatory strategies that facilitate portfolio expansion, collaborating with global and regional stakeholders to provide strategic and functional insights to the LATAM team.
- Interface cross‑functionally within Regulatory Affairs and with departments such as Commercial and Global Marketing.
- Identify Mexican regulatory requirements impacting strategy and determine optimal pathways to meet project goals focused on Bioprocess, Novel Therapies, Vaccines, APIs, and Excipients. Provide regulatory intelligence and strategic input for assigned products to expand the portfolio.
- Maintain communication with Regulatory Authorities to foster productive dialogue, detect regulatory trends, and positively influence discussions.
- Conduct regulatory surveillance impacting Merck and customers, support customer guidance through meetings, and deliver training sessions to enhance the commercial team’s understanding of the regulatory landscape.
- Develop procedures for local regulatory needs and offer expert advice on applicable regulations.
- Collaborate as a team player with strong organizational skills, flexibility, and a detail‑oriented mindset focused on meeting deadlines.
Who You Are
A degree in pharmacy, life sciences, or a related field.Direct experience in Mexico essential; familiarity with LATAM markets’ Regulatory Affairs a plus.Minimum of 8 years in Regulatory Affairs.Experience interacting with Regulatory Authorities and proven knowledge in providing strategic regulatory guidance on Bioprocess, Vaccines, and Life Sciences.A digital and AI mindset, along with demonstrated leadership, problem‑solving, negotiation, and communication skills.Ability to work independently while thriving in a team‑oriented environment.Strong verbal and written communication, excellent negotiation and diplomacy skills, and experience addressing complex issues with customers, suppliers, and senior management.Excellent organizational and presentation skills, and fluency in English.What We Offer
We believe diverse perspectives drive excellence and innovation. Join us to empower inclusion, belonging, and human progress. Build a culture of curiosity and work your magic.
Apply now and become part of a team dedicated to sparking discovery and elevating humanity.
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