Regulatory Affairs Specialist

hace 2 días

Naucalpan de Juárez, México Merck Group A tiempo completo
About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Merck Group. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with local regulations and guidelines for our pharmaceutical products and medical devices.

Key Responsibilities
  • Develop and implement regulatory strategies for our products to achieve regulatory approvals and ensure compliance with local regulations and internal SOPs.
  • Supervise RA Coordinator activities and provide regulatory advice and support as required.
  • Maintain awareness of ongoing projects and provide regulatory advice to define the best approach/strategy to ensure business continuity.
  • Identify regulatory risks and escalate them in a timely manner.
  • Review new regulations and guidelines and provide impact analysis within RA and impacted functions.
  • Interact closely with Local/Regional/Global RA teams and other functions to obtain data required for projects and provide early visibility on identified risks.
  • Prepare regulatory deliverables, such as reports, spreadsheets, and presentations.
  • Assure compliance with due dates and planned dates for products/project assigned or under supervision.
  • Organize and conduct training sessions within RA team to enhance regulatory knowledge.
  • Actively participate in Technical Committees to update internally.
Requirements
  • Bachelor's degree in Pharmaceutical and Bioscience related science.
  • At least 10 years of working experience in Regulatory Affairs for the pharmaceutical Industry.
  • Proven experience managing biotechnological products, small molecules, and medical devices.
  • Proficiency using IT tools for remote work.
  • Solid knowledge of the Mexican regulatory framework for biotechs, small molecules, and Medical Devices.
  • Strong interpersonal, planning, and problem-solving skills are required.
  • Senior role responsible for assuring compliance with local regulations for all assigned regulatory activities.
  • Must have the ability to work as an effective and engaged team member in a fast-paced environment.
  • Strong initiative and follow-through are essential.
  • It is expected that this senior role can provide accurate regulatory guidance within the entire RA team or also to other cross-functional stakeholders.
  • Communication and self-driven behaviors are required.
  • Skills to contribute and influence in a remote-work team environment.
  • Proficient in English communication skills both oral and written.
What We Offer

We are a diverse team of curious minds who 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.

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