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Director, Regulatory Affairs

3 weeks ago

Singapore beBeeRegulatory Full time $120,000 - $180,000
Regulatory Affairs Director

We are seeking a seasoned Regulatory Affairs Director to lead our team in providing strategic regulatory support for clinical trials and drug development. The successful candidate will have excellent leadership skills, a strong understanding of international regulatory requirements, and experience in managing cross-functional teams.

About the Role

The Director Regulatory Affairs will be responsible for:

  • Developing and implementing regulatory strategies to ensure compliance with international regulations;
  • Providing technical guidance and training to internal stakeholders on regulatory matters;
  • Managing relationships with regulatory authorities and ensuring effective communication of company positions;
  • Leading the preparation and submission of regulatory documents, including CTA/IND, annual reports, and routine amendments;
  • Coordinating with other departments to ensure alignment with corporate quality initiatives and business objectives;
  • Maintaining up-to-date knowledge of emerging regulatory requirements and trends.
Key Qualifications

To be considered for this role, you should possess:

  • A bachelor's degree in a relevant field (e.g., life sciences, law);
  • At least 10 years of experience in regulatory affairs, preferably in a leadership position;
  • Strong knowledge of international regulatory requirements, including ICH/GCP guidelines;
  • Excellent communication, leadership, and project management skills;
  • Ability to work effectively in a fast-paced environment and prioritize multiple tasks.
Benefits

This is an exciting opportunity to join our team and contribute to the success of our organization. As a Regulatory Affairs Director, you can expect:

  • A competitive salary and benefits package;
  • Ongoing professional development and training opportunities;
  • A dynamic and supportive work environment;
  • The chance to work on high-profile projects and collaborate with industry experts.