Regulatory Affairs Director for Global Compliance

4 days ago


Singapore SL-Human Resource Consultancy Pte Ltd Full time
Job Overview

We are seeking an experienced Regulatory Affairs Director to join our team in Singapore.

Job Description:
  • Key Responsibilities:
    • Compliance and Submissions:
      • Oversee the preparation, submission, and maintenance of regulatory filings and submissions to health authorities.
      • Ensure compliance with local, regional, and international regulatory requirements.
      • Monitor changes in regulatory policies and guidelines, and communicate their impact to relevant stakeholders.
    • Regulatory Affairs Management:
      • Lead and manage the regulatory affairs team, providing guidance, mentorship, and development opportunities.
      • Coordinate and oversee regulatory activities across multiple projects and therapeutic areas.
      • Represent the company in meetings and communications with regulatory agencies.
    • Cross-Functional Collaboration:
      • Work closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.
      • Provide regulatory expertise and support to cross-functional project teams.
      • Facilitate effective communication and collaboration between regulatory affairs and other departments.
Requirements
  • Qualifications:
    • Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field. Advanced degree (PhD, PharmD, or MD) is preferred.
  • Experience:
    • Minimum 10 years of experience in regulatory affairs within the pharmaceutical industry, with at least 5 years in a leadership role.
    • Proven track record of successful regulatory submissions and approvals.
Compensation

The estimated salary for this position is SGD $120,000 - $180,000 per annum, depending on experience.



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