Asia Pacific Regulatory Affairs Specialist

7 days ago

Singapore beBeeRegulatory Full time $180,000 - $220,000
Job Description

The Asia Pacific Regulatory Manager plays a pivotal role in overseeing product registrations and regulatory pathways within this region.

Key Responsibilities:

  • Regulatory Strategy and Submission: Independently manages and executes all aspects of successful preparation, submission, and timely approval of applications, variations, post-approval reporting obligations, and general product life cycle management of assigned programs.
  • Regulatory Compliance: Ensures compliance with Asia Pacific regulatory bodies, monitors regulatory changes and emerging trends, and provides guidance to internal stakeholders on changes and their impact.
  • Liaison with Regulatory Authorities: Acts as the primary point of contact with regulatory authorities, prepares and participates in meetings, addresses queries, and negotiates approvals.
  • Cross-functional Collaboration: Works closely with internal teams (clinical, medical affairs, manufacturing, quality assurance, and marketing) to ensure alignment on regulatory strategy and project timelines.

Requirements:

  • A degree in life sciences, pharmacy, or a related field is preferred.
  • Minimum 8 years of regulatory affairs experience in the healthcare industry in Asia Pacific.
  • Experience with oncology clinical trials and regulatory requirements for investigational new drugs.
  • Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in development and life cycle management.
  • Excellent communication and negotiation skills, both written and verbal, with the ability to engage effectively with regulatory agencies, cross-functional teams, and senior leadership.
  • Strong problem-solving skills and the ability to navigate complex regulatory environments.
  • Demonstrated ability to manage multiple projects simultaneously, with a high degree of organization and attention to detail.
  • Ability to work independently and as part of a collaborative team in a fast-paced environment.
Benefits

This role offers a unique opportunity to leverage your expertise in regulatory affairs and contribute to the success of our operations in the Asia Pacific region.

We are committed to fostering a dynamic and supportive work environment that encourages growth, innovation, and collaboration.

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