Regulatory Affairs CMC Lead

PackGene Biotech Co., Ltd.; Houston (TX); Remote; USD 100,000 - 130,000; Part time

Job summary

A leading company in the gene therapy industry seeks a Regulatory Affairs CMC Lead to develop and implement regulatory strategies. The role involves authoring IND submissions and managing timelines while requiring over 5 years of experience and proficiency in FDA regulations. Ideal candidates will possess strong communication skills and project management capabilities, with an advanced degree preferred.

Qualifications

• 5+ years of hands-on regulatory affairs experience in pharmaceutical or biotech fields.
• Proficiency in US FDA, EMA regulations, and ICH guidance.
• Strong communication and negotiation skills.

Responsibilities

• Authoring and reviewing eCTD contents for IND submissions.
• Managing timelines for regulatory submissions, including IND, DMF, and BLA.
• Supporting regulatory strategies for customer programs.

Skills

Communication

Project Management

Regulatory Knowledge

Education

Advanced degree preferred

Job description

Job Title: Regulatory Affairs CMC Lead

Location: Remote

Department: Regulatory Affairs

Reports To: Chief Technical Officer

FLSA Status: Part-Time/Non-Exempt

Mission Statement

The mission of PackGene Biotech is to accelerate gene therapy product development by providing an integrated one-stop solution including plasmid, viral vector, fill-finish, and QC analytical services for the gene therapy industry.

Company Background

Founded in 2014 and headquartered in Guangzhou, China, PackGene Biotech provides CRO/CDMO services to the emerging gene therapy industry and research institutes. Its US subsidiary is expanding its footprint to Houston, TX. We are seeking highly motivated individuals to join our growing Houston team and lead our organization.

Overview

The Regulatory CMC Lead is responsible for developing and implementing regulatory strategies for the organization, focusing on advancing new gene therapy candidates through preclinical, clinical, and commercial stages.

Roles and Responsibilities

• Authoring and reviewing eCTD contents for IND submissions to US and other regulatory authorities.
• Creating templates for eCTD documents for US submissions.
• Preparing briefing documents for regulatory meetings such as pre-IND meetings.
• Addressing regulatory questions from clients and agencies.
• Managing timelines for regulatory submissions, including IND, DMF, and BLA.
• Providing regulatory reviews for manufacturing sites, quality systems, GMP manufacturing, and analytical development.
• Participating in internal site audits as a regulatory SME.
• Communicating with clients regarding submission timelines and document readiness.
• Supporting regulatory strategies for customer programs and representing RA in cross-functional teams.
• Performing other tasks as assigned.

Qualifications

• 5+ years of hands-on regulatory affairs experience in pharmaceutical, biotech, biologics, or CDMO fields.
• Advanced degree preferred.
• Proficiency in US FDA, EMA regulations, and ICH guidance.
• Experience with eCTD content drafting and regulatory submissions.
• Strong communication and negotiation skills.
• Project management and cross-functional leadership abilities.
• Ability to prioritize multiple projects.
• Excellent stakeholder communication skills.