Job Description
Summary
This position reports to the head of regulatory affairs of Gan & Lee Pharmaceuticals USA Corporation or designee. As the founding CMC Regulatory Affairs hire at the US affiliate, this individual serves as the primary gatekeeper for all Chemistry, Manufacturing, and Controls (CMC) regulatory submissions and strategies for products destined for the US (FDA) ,EU (EMA) and other applicable markets. The Director reviews, evaluates, and approves CMC submission packages prepared by the China-based headquarters team, ensuring full compliance with global regulatory requirements. This role provides critical CMC regulatory guidance to support the company's product development and lifecycle management programs across the US,EU and other applicable regions.
Education and Credentials
- Minimum Bachelor of Science degree in Chemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related scientific discipline is required. Advanced degree (M.S., Ph.D., or Pharm.D.) is strongly preferred.
- RAC (Regulatory Affairs Certification) or equivalent professional certification is preferred.
Experience
- 10+ years of pharmaceutical/biopharmaceutical industry experience is required, with at least 8 years in CMC Regulatory Affairs supporting US (FDA) and/or EU (EMA) product development and post-approval activities.
- Rich experience with developing CMC sections of regulatory submissions, including IND/CTA, NDA/BLA/MAA, and post-approval supplements/variations.
- Deep knowledge of ICH guidelines (Q1-Q14), eCTD Module 3, IMPD and CMC regulatory requirements.
- Direct experience interacting with FDA and/or EMA on CMC-related matters, including meeting preparation, information requests, and deficiency responses.
- Experience with biologics, biosimilars, and/or endocrine drugs (e.g., insulin, GLP-1 receptor agonists) is preferred.
- Experience working in a multi-cultural, cross-border environment with China-based or Asia-based headquarters is highly preferred.
- Familiarity with GMP, , and relevant manufacturing and analytical regulatory standards.
Skills
- Strong strategic thinking with the ability to develop and execute CMC regulatory strategies aligned with global development plans.
- Excellent analytical and problem-solving skills; ability to critically evaluate CMC data packages and identify regulatory risks.
- Exceptional written and oral communication skills in English. Proficiency in Mandarin Chinese is a strong plus.
- Ability to operate independently with minimal supervision as the sole CMC RA professional at the US affiliate.
- Strong cross-cultural collaboration skills with demonstrated ability to work effectively with China-based teams across time zones.
- Demonstrated ability to manage multiple projects concurrently and prioritize under tight timelines.
- Strong proficiency in Microsoft Office (Word, Excel, PowerPoint) and regulatory documentation system (e.g., Sharepoint and Veeva Rim).
- Enthusiastic, ethical, detail-oriented, and committed to the organization's mission and goals.
Responsibilities
- Serve as the US-based CMC regulatory gatekeeper: review, evaluate, and approve all CMC submission packages prepared by the China headquarters team prior to filing with FDA ,EMA and other health authorities.
- Develop and execute CMC regulatory strategies for US (FDA) ,EU (EMA) and other global markets, including IND/CTA, NDA/BLA/MAA, and post-approval lifecycle submissions.
- Ensure all CMC sections of regulatory submissions comply with FDA, EMA, and ICH requirements, including eCTD Module 3 and IMPD content and formatting standards.
- Liaise with China-based headquarters CMC teams to coordinate submission timelines, resolve technical and regulatory questions, and align on global CMC strategies.
- Represent the company in CMC-related interactions with global health authorities, including pre-submission meetings, information requests, and agency correspondence.
- Monitor and communicate changes in global CMC regulatory requirements, guidance documents, and industry best practices to headquarters and internal stakeholders.
- Provide CMC regulatory input to cross-functional product development teams, including formulation, analytical, manufacturing, and quality functions.
- Support post-approval CMC activities including supplements, variations, annual reports, and responses to agency queries.
- Establish and maintain CMC regulatory SOPs and best practices for the US affiliate's regulatory operations.
- Provide strategic input to senior management on CMC regulatory risks, timelines, and resource planning for development programs.
Job Tags
Full time, Work at office