Senior Regulatory Strategist
4 days ago
Job Description
The Private Advertiser is hiring a Senior Regulatory Strategist to drive regulatory compliance and product registrations in Asia Pacific. This critical role requires expertise in developing and implementing regulatory strategies, managing submissions, and maintaining relationships with regulatory authorities.
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.
- 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.
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