
Regulatory Lead
2 days ago
Overview
The Regulatory Manager, APAC oversees the product registrations and regulatory pathways in Asia Pacific. They work with other stakeholders to create effective business and project implementation plans.
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
- Effectively communicate regulatory strategies, submission plans, and timelines; assess impact of trends, regulations, and changes related to assigned programs
- Manage the regulatory submission process, including timely preparation of submission documents and ensuring submission within project/commercial launch timelines
- Monitor regulatory changes and emerging trends in the space where the company operates
Qualifications
- 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 lifecycle management
- Excellent communication and negotiation skills, both written and verbal
Seniority level: Director
Job function: Quality Assurance and Other
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