Regulatory Operations Manager

2 weeks ago

Singapore beBeeRegulatory Full time $1,200,000 - $1,500,000
Regulatory Role Overview

The primary function of the Regulatory Manager is to oversee product registrations and regulatory pathways in Asia Pacific.

This role requires effective collaboration with stakeholders to create business and project implementation plans that ensure compliance with Asia Pacific regulations.

Key Responsibilities:
  • Develop and implement regulatory strategies for products in line with global objectives and local requirements.
  • Prepare, review, and submit regulatory dossiers to Asia Pacific regulatory bodies.
  • Manage the regulatory submission process, including timely preparation of submission documents and ensuring submission within project/commercial launch timelines.
  • Ensure compliance with Asia Pacific regulatory bodies and provide guidance on regulatory changes and emerging trends.
  • Liaise with regulatory authorities, maintain productive relationships, and facilitate efficient approval processes.
  • Cross-functional collaboration with internal teams 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.
  • Strong problem-solving skills and ability to navigate complex regulatory environments.
  • Demonstrated ability to manage multiple projects simultaneously.

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