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About the Role

Lead and manage regulatory affairs within the CMC function, developing and executing global regulatory CMC strategies for complex cell therapy products. Ensure alignment with industry standards and regulatory requirements, and provide expertise in CMC agency interactions and strategy development. This role offers significant input on regulatory processes and procedures, and assists senior management in understanding CMC regulatory strategies and their impact across therapeutic areas. Familiarity with GMP Quality, CMC development, and clinical regulatory strategy is highly desired, with potential for VP-level direct reporting.

Responsibilities

Develop CMC regulatory strategies and manage related regulatory activities.
Work with Pharmaceutical Development to prepare project plans and timelines, coordinating and overseeing all types of regulatory CMC submissions and meetings.
Supervise/manage others to ensure reporting requirements and commitments for INDs, BLAs, CTAs, MAAs, etc., are met.
Prepare and author updates in conjunction with cross-functional teams.
Advise on the global regulatory phase-appropriate compliance of gene and cell therapy products, including evaluation of CMC change controls and strategic assessment of process/product comparability.
Lead the preparation, authoring, review, and filing of high-quality CMC sections of regulatory submissions with robust agency interactions.
Maintain a centralized archive for tracking and monitoring regulatory CMC commitments and agency reporting obligations.
Create and issue status reports and other communications to the organization.
Provide strategic CMC regulatory support, guidance, and expertise as the primary point of contact to cross-functional teams.
Ensure all applicable regulatory requirements/options and associated risks are considered and incorporated into development programs.
Ensure products are developed and manufactured in compliance with appropriate regulations and guidelines.
Work across functional groups to identify issues that may delay timelines and provide solutions.
Support the resolution of project-specific technical/functional issues.
Ensure the regulatory conformance of technical documentation, including technical transfer protocols, validation protocols, technical reports, manufacturing, and labeling information.
Provide guidance and advice on regulatory CMC environments and trends.
Provide assessment of the impact of new and changing regulations/requirements.
Author, review, and maintain regulatory and scientific documents to support business and submission needs.
Track and report on Medical Writing and Regulatory Operations projects, timelines, and key milestones.

Requirements

BA/BS in a scientific field of study.
10+ years of relevant experience in Regulatory within the pharmaceutical/biotech industry.
Strong knowledge, experience, and leadership in interpreting regulations and guidelines related to biologics drug development.
Experience in the gene or cell therapy area is preferred.
Proven ability to analyze and organize information logically.
In-depth understanding and application of industry standards and international regulations and guidelines.
Experience in communicating regulatory strategy, submission documents, and plans both internally and externally.
Ability to coordinate and prioritize multiple projects in a fast-paced, deadline-driven start-up environment.
Strong collaboration, teamwork, organizational skills, and attention to detail.
Excellent written and verbal communication skills.
Ability to travel 20%.

Skills

Regulatory Affairs
CMC Strategy
Cell Therapy
GMP Quality
CMC Development
Clinical Regulatory Strategy
Agency Interactions
IND
BLA
CTA
MAA
Change Control Evaluation
Process Comparability Assessment
Product Comparability Assessment
Technical Documentation
Technical Transfer Protocols
Validation Protocols
Technical Reports
Manufacturing Information
Labeling Information
Medical Writing
Regulatory Operations
Collaboration
Teamwork
Organization
Attention to Detail
Written Communication
Verbal Communication

Location

Remote
Hybrid
Onsite

Work Type

Full-time

Experience Level

10+ years

Education Level

BA/BS

Salary/Compensations

$245,000-285,000

Benefits

Base salary
Annual target bonus
Equity
Significant growth opportunity
Empathetic, supportive, and collaborative colleagues and work environments

About the Company

The company is expanding and offers significant growth opportunities.