ASSOCIATE MANAGER – CMC REGULATORY

Lusynco; Hinoba-an; On-site; PHP 1,200,000 - 2,000,000; Full time

Job summary

Lusynco seeks an experienced Regulatory Affairs professional to lead global CMC strategies for marketed products. The role balances business benefits with strict regulatory compliance, coordinating lifecycle management across multiple product classes and geographies.

You will author submissions, mentor the CMC team, and stay current with FDA/CVM, EMA, VICH and cGMP guidelines to ensure robust registrations worldwide.

Qualifications

• 5+ years in Global Regulatory Affairs (CMC)
• Strong knowledge of FDA/CVM, EMA, VICH and cGMP guidelines
• Experience with CMC registrations in US/EU/RoW and across geographies

Responsibilities

• Design and develop CMC regulatory strategies for marketed products balancing business benefits with global regulatory compliance.
• Oversee end-to-end Lifecycle Management of Small/M large Molecules, Sterile products, Biotech/fermentation products and specialized dosage forms.
• Author and lead high-quality CMC submissions (supplements, variations, renewals, annual reports) across multiple geographies.
• Collaborate with R&D, Quality, Manufacturing and global regulatory partners.
• Provide training and mentorship to the CMC team and stay updated with FDA/CVM and EMA guidelines.

Skills

Global regulatory affairs

CMC lifecycle knowledge

Regulatory guidelines (FDA/CVM/EMA/VIC

Communication skills

Education

Science degree (M.Sc., B.Pharm, M.Pharm)

Tools

RIM tools

Job description

POSITION DETAILS

Strategy & Compliance: Design and develop CMC regulatory strategies for marketed products, balancing business benefits with global regulatory compliance.

Lifecycle Management

Oversee end-to-end Lifecycle Management (LCM) of Small/Large Molecules, Sterile preparations, Biotech/Fermentation products, and specialized dosage forms.

Submission Management

Author and lead the preparation of high-quality CMC submissions (supplements, variations, renewals, annual reports) across multiple geographies.

Cross-Functional Collaboration

Partner with internal teams in R&D, Quality, and Manufacturing, as well as global regulatory partners.

Guidance & Mentorship

Maintain up-to-date knowledge of FDA/CVM and EMA guidelines, and provide training and mentorship to CMC team members.

Education

Degree in Science (M.Sc, B.Pharm / M.Pharm, Postgraduate in Vet Sciences, etc.).

Experience

5+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management.

Strong knowledge of FDA/CVM, EMA, VICH, and cGMP guidelines.

Experience with CMC registrations in the US, Europe, and Rest of the World (RoW).

Hands-on experience with Regulatory Information Management Tools and Systems.

Strong communication, organizational, and decision-making skills.