Regulatory Affairs Senior Expert at Merck KGaA

Naucalpan de Juárez Municipality, México, Mexico -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

0.0

Posted On

08 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Bioprocess, Vaccines, Life Sciences, Strategic Guidance, Regulatory Intelligence, Communication Skills, Negotiation Skills, Organizational Skills, Problem-Solving, Leadership, Flexibility, Detail-Oriented, Training, Collaboration, Customer Guidance

Industry

Pharmaceutical Manufacturing

Description

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 Senior Regulatory Affairs Expert, you will support one of our Life Science Divisions by managing regulatory activities related to assigned portfolio products. You will 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. You will interface cross-functionally within Regulatory Affairs and with departments such as Commercial and Global Marketing. You'll identify Mexican regulatory requirements impacting strategy and determine optimal pathways to meet project goals focused on Bioprocess, Novel Therapies, Vaccines, APIs, and Excipients. Providing regulatory intelligence to product teams and offering strategic input for assigned products will be crucial for expanding the portfolio. Maintaining communication with Regulatory Authorities will help foster productive dialogue on assigned products, allowing you to detect regulatory trends and positively influence discussions. You will 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. Additionally, developing procedures for local regulatory needs and offering expert advice on applicable regulations are key responsibilities. You are a collaborative 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 is essential, and familiarity with LATAM markets’ Regulatory Affairs is a plus. A minimum of 8 years of experience in Regulatory Affairs is required. Experience interacting with Regulatory Authorities and proven knowledge in providing strategic regulatory guidance on Bioprocess, Vaccines, and Life Sciences is required. A digital and AI mindset, along with demonstrated leadership, problem-solving, negotiation, and communication skills, will be beneficial. You should be capable of working independently while thriving in a team-oriented environment. Strong verbal and written communication, excellent negotiation and diplomacy skills, and experience in addressing complex issues with customers, suppliers, and senior management are important. Excellent organizational and presentation skills, along with fluency in English, are essential for this role. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Responsibilities

As a Senior Regulatory Affairs Expert, you will manage regulatory activities related to assigned portfolio products and plan regulatory strategies for portfolio expansion. You will maintain communication with Regulatory Authorities and provide regulatory intelligence to product teams.