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Regulatory Affairs Director

hace 2 meses

Naucalpan de Juárez, México Hydro - US Facilities A tiempo completo
About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Hydro - US Facilities. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve regulatory approvals.

Key Responsibilities
  • Develop and implement regulatory strategies for pharmaceutical products and medical devices, ensuring alignment with local regulations and company policies.
  • Supervise Regulatory Coordinator activities and provide regulatory advice and support as required.
  • Monitor compliance with due dates and identify regulatory risks, escalating them in a timely manner.
  • Review new regulations and guidelines, providing impact analysis within the Regulatory Affairs team and impacted functions.
  • Interact closely with Local/Regional/Global Regulatory 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 assigned projects.
  • Organize and conduct training sessions within the Regulatory Affairs team to enhance regulatory knowledge.
  • Actively participate in Technical Committees to update internal knowledge and deliver regulatory guidance for projects executed at the hub level.
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 Mexican regulatory framework for biotechs, small molecules, and Medical Devices.
  • Strong interpersonal, planning, and problem-solving skills.
  • Senior role responsible for assuring compliance with local regulations for all assigned regulatory activities.
  • Ability to work as an effective and engaged team member in a fast-paced environment.
  • Strong initiative and follow-through.
  • Accurate regulatory guidance within the entire Regulatory Affairs team or other cross-functional stakeholders.
  • Communication and self-driven behaviors.
  • Skills to contribute and influence in a remote-work team environment.
  • Proficient in English communication skills, both oral and written.
About Us

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 their own pace.