Regulatory Affairs Manager

hace 2 semanas

Naucalpan de Juárez, México The businesses of Merck KGaA, Darmstadt, Germany A tiempo completo

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.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role

  • In this senior position, you will ensure compliance with local regulations for all assigned regulatory activities while aligning with company policies and SOPs.
  • You will actively contribute as a team member in a dynamic environment, demonstrating strong initiative and follow-through.
  • The role involves providing precise regulatory guidance to the RA team and cross-functional stakeholders for regulatory strategy development.
  • You will need to assert yourself vocally and drive initiatives independently.
  • Collaborating effectively in a remote work setting is essential.
  • You will establish regulatory strategies for assigned products to achieve approvals, ensuring compliance with local regulations and internal policies.
  • Supervision of local RA Coordinator activities will be part of your responsibilities, ensuring the execution of defined strategies and adherence to timelines.
  • You will monitor ongoing lifecycle management projects, advising on regulatory strategies to maintain business continuity. 
  • Engaging with trade associations and analyzing new regulations to assess impacts will also be crucial.

Who You Are

  • You hold a Bachelor's degree in Pharmaceutical or Bioscience-related fields and possess strong English language skills.
  • With at least 10 years of experience in Regulatory Affairs within the pharmaceutical industry, you have a proven track record managing biotechnological products and medical devices.
  • You are knowledgeable about the Mexican regulatory framework for biotechs, small molecules, and medical devices.
  • Your communication skills, both oral and written, are proficient in English.
  • You excel in negotiation, planning, and problem-solving, and you are skilled in regulatory database management.
  • Familiarity with IT tools for remote work is essential, as is the ability to influence and contribute effectively within a remote team environment.

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

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