Regulatory Consulting Manager

hace 2 semanas

Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo

Job Summary


We are seeking a highly skilled Regulatory Consulting Manager to join our team at Syneos - Clinical And Corporate - Prod. As a key member of our regulatory department, you will be responsible for contributing to the planning and preparation of regulatory submissions, managing project teams, and providing regulatory advice to clients.


Key Responsibilities



  2. Contribute to the planning and preparation of regulatory submissions, including IND, PMA, NDA, and CTD.
  3. Manage project teams and ensure timely delivery of regulatory submissions.
  4. Provide regulatory advice to clients and represent the regulatory department in meetings with clients and regulatory authorities.
  5. Develop, review, and monitor project budgets, reviewing client invoicing and ensuring compliance with regulatory requirements.
  6. Act as a key point of contact for clients and regulatory authorities, providing technical support and guidance as needed.
  7. Conduct regulatory research and provide strategic and operational advice to clients.
  8. Collaborate with other departments to ensure alignment with business development goals and objectives.
  9. Participate in quality improvement efforts to increase operational efficiency.
  10. Develop and maintain a reputation for the company as an industry leader in regulatory affairs.

Requirements



  • BS degree in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
  • Comprehensive regulatory knowledge and understanding of pharmaceutical and/or medical device product development.
  • Excellent interpersonal, communication, and customer service skills.
  • Good quality management and budgeting skills.
  • Ability to work independently and as part of a team.

About Us


Syneos - Clinical And Corporate - Prod is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.


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