Regulatory Affairs Specialist APAC

4 days ago


Singapore Private Advertiser Full time

Job Overview

The Private Advertiser seeks a highly skilled Regulatory Affairs Specialist to oversee the product registrations and regulatory pathways in Asia Pacific. This role requires strong expertise in ensuring compliance with Asia Pacific regulations, influencing key decision-making processes, and contributing to enterprise-wide impact.

Main Responsibilities

  • Develop and implement regulatory strategies for products in line with the company's global objectives and local requirements.
  • Prepare, review, and submit regulatory dossiers to Asia Pacific regulatory bodies.
  • Effectively communicate regulatory strategies, submission plans, and timelines; assess trends, regulations, and changes related to assigned programs.
  • Liaise with regulatory authorities, act as primary point of contact, and maintain productive relationships to 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 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.


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