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Regional Regulatory affairs Director, Asia Pacific

4 months ago

Singapur, Singapore SL-Human Resource Consultancy Pte Ltd Full time

Job Title: Regulatory Affairs Director

Location:  Singapore

Department: Regulatory Affairs

Reports to: Vice President of Regulatory Affairs

Position Summary:

Our client is seeking an experienced and strategic Regulatory Affairs Director to join the team in Singapore. The Regulatory Affairs Director will be responsible for overseeing and managing all regulatory activities, ensuring compliance with local and international regulations, and driving regulatory strategy to support the company's business objectives.

Key Responsibilities:
  • Regulatory Strategy:
    • Develop and implement regulatory strategies to support product development, approval, and lifecycle management.
    • Identify and address regulatory risks and opportunities to facilitate business growth.
    • Ensure alignment of regulatory strategies with global regulatory and business goals.
  • Compliance and Submissions:
    • Oversee the preparation, submission, and maintenance of regulatory filings and submissions (e.g., IND, NDA, BLA, MAA) 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.
  • Regulatory Intelligence:
    • Stay up-to-date with evolving regulatory trends, policies, and best practices.
    • Conduct regulatory intelligence and competitive analysis to inform strategic decision-making.
    • Provide regulatory insights and recommendations to senior management.
  • Quality Assurance:
    • Ensure adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
    • Participate in internal and external audits to ensure regulatory compliance.
    • Develop and implement corrective and preventive actions (CAPA) to address compliance issues.
  • Documentation and Reporting:
    • Maintain accurate and comprehensive regulatory documentation and records.
    • Prepare and present regulatory reports, summaries, and updates to senior management and other stakeholders.
    • Ensure timely and effective communication of regulatory requirements and updates.
Qualifications and Skills:
  • Education:
    • Bachelors or Masters degree in Pharmacy, Life Sciences, Chemistry, or a related field. Advanced degree (PhD, PharmD, or MD) is preferred.
  • Experience:
    • Minimum of 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.
  • Skills:
    • Strong knowledge of local, regional, and international regulatory requirements and guidelines.
    • Excellent strategic thinking and problem-solving abilities.
    • Strong leadership and team management skills.
    • Effective communication and interpersonal abilities.
    • Strong organizational and project management skills.
    • Ability to work effectively in a fast-paced, dynamic environment.
  • Certifications:
    • Regulatory Affairs Certification (RAC) is a plus.
Working Conditions:
  • Full-time position.
  • Office environment with occasional travel required for regulatory agency meetings, conferences, and inspections.
  • May require working outside of regular business hours to meet project deadlines and regulatory requirements.