Job Description

Candidate will be remote until the site re opens *2-3 years Regulatory Affairs CMC experience. CMC-specific regulatory knowledge & experience. *Previous work experience in the Pharmaceutical/Biotech industry *Ideal candidate would have RA experience within JAPAC region Job Details: This is an opportunity for a Manager position in client Regional Regulatory Affairs, CMC group. This group's purpose is to facilitate product development and global registration by developing and executing Regulatory CMC strategies for client products throughout the product lifecycle. The RA CMC Asia Pacific lead is responsible for the planning, management, coordination and execution of regulatory submissions for products within the JAPAC Regional portfolio according to the approved filing plan in compliance with corporate standards, and local regulatory requirements. The RA CMC Asia Pacific Lead is the primary point of contact and interface with the Regional Regulatory Lead (RRL) and Local Regional Representative (LRR) for specific CMC strategy and CMC activities that impact product development within the region. The RA CMC Asia Pacific lead will support the RA CMC Global teams for the preparation of Clinical Trial applications (CTA), Marketing Applications (MA), and Post-Approval changes. Additional responsibilities of the RA CMC Asia Pacific Lead include: • Contribute to the development of the Global Regulatory CMC strategy and execute the preparation of CMC components for CTAs and MAs, and LCM submissions for client products within JAPAC • Assess proposed manufacturing and quality changes for regional reporting requirements, and manage subsequent post approval variation submissions across the region. • Coordinate and manage responses to Health Authority requests for information related to CMC matters. • Document Archiving: Ensure appropriate compliance with archiving/tracking and monitor metrics from tracking systems. • Conduct contingency regulatory planning/risk assessment for product development plans and support regulatory interaction strategies.

Qualifications

TOP 3 MUST HAVE SKILL SETS:

• 2-3 years Regulatory Affairs CMC experience. CMC-specific regulatory knowledge & experience. • Previous work experience in the Pharmaceutical/Biotech industry. • Strong & effective oral and written communication skills; proven ability to communicate effectively with different management levels.

Additional Information

Candidate will be remote until the site re opens