Asia Pacific Regulatory Strategy Director

3 weeks ago

Singapore SL-Human Resource Consultancy Pte Ltd Full time

Job Title: Asia Pacific Regulatory Strategy Director

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Location: Singapore

Department: Regulatory Affairs

Reports to: Vice President of Regulatory Affairs

About the Role:

We are seeking an experienced and strategic Regulatory Strategy Director to join our team in Singapore. The successful candidate will be responsible for overseeing and managing all regulatory activities, ensuring compliance with local and international regulations, and driving regulatory strategy to support our business objectives.

This is a full-time position that requires a strong leader who can develop and implement effective regulatory strategies, ensure alignment with global regulatory goals, and provide guidance to cross-functional project teams.

The ideal candidate will have a minimum of 10 years of experience in regulatory affairs within the pharmaceutical industry, with at least 5 years in a leadership role. They must have a proven track record of successful regulatory submissions and approvals, as well as excellent strategic thinking and problem-solving abilities.

Main 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.
Requirements:
  • 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.
About SL-Human Resource Consultancy Pte Ltd:

SL-Human Resource Consultancy Pte Ltd is a leading human resource consultancy that specializes in providing expert advice and solutions to businesses in the pharmaceutical and biotechnology industries. We are committed to helping our clients achieve their business objectives through effective talent acquisition, development, and management.

We offer a competitive salary package, including a base salary of SGD 180,000 per annum, to attract and retain top talent in the industry. If you are a motivated and experienced professional looking for a new challenge, please submit your application to us today

About the Company:

SL-Human Resource Consultancy Pte Ltd is a reputable human resource consultancy that provides expert advice and solutions to businesses in the pharmaceutical and biotechnology industries. We are committed to helping our clients achieve their business objectives through effective talent acquisition, development, and management.

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