Director CMC Regulatory

Enigma Search; South San Francisco (CA); In loco; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

Enigma Search in the United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small molecules and monoclonal antibodies, shaping strategies for accelerated development and successful product registrations.

The role partners with CMC, Quality, and Manufacturing teams to prepare submissions (NDA, BLA, MAAs), maintain the CTD, ensure regulatory readiness, and oversee changes across regions from development through commercialization.

Competenze

• BS or MS in Chemistry, Biology, Pharmacy or related field; PhD/PharmD preferred.
• Minimum 10 years biopharma experience with 7+ in CMC regulatory affairs.
• Experience supporting major marketing applications (NDA/BLA/MAA).
• Strong knowledge of GMP, ICH, and global regulatory requirements.

Mansioni

• Create global CMC regulatory strategies for clinical development and product registrations.
• Lead preparation of CMC documentation for regulatory submissions and responses.
• Collaborate with cross-functional teams and engage health authorities worldwide.

Descrizione del lavoro

We are a research and development organization dedicated to advancing our understanding of the biological mechanisms that influence human aging. By leveraging cutting-edge technologies, innovative model systems, and a strong commitment to discovery science, we aim to translate groundbreaking research into therapies that help people live longer, healthier lives.

Our collaborative environment brings together world-class scientists, technology experts, and industry partners to drive scientific innovation and advance a diverse pipeline of therapeutic programs. Through a combination of pioneering research and drug development expertise, we are focused on accelerating meaningful medical breakthroughs.

Position Overview

The Director, Regulatory CMC will provide strategic leadership for global Chemistry, Manufacturing, and Controls (CMC) regulatory activities across a portfolio of small molecules and monoclonal antibodies. This individual will be responsible for developing and executing regulatory strategies that support accelerated clinical development, successful product registration, and lifecycle management.

Serving as a critical partner to CMC and Quality teams, the Director will oversee the preparation and maintenance of CMC-related content for investigational and commercial submissions globally. The successful candidate will combine strong scientific expertise, regulatory insight, and exceptional communication skills to drive regulatory success throughout the product lifecycle, from early development through commercialization.

This role requires a thorough understanding of the regulatory considerations specific to both small molecule and biologic products, as well as experience interacting directly with global health authorities.

Key Responsibilities

Regulatory Strategy & Health Authority Engagement

• Develop and execute global CMC regulatory strategies to support clinical development, product approvals, and ongoing regulatory compliance across commercial markets.
• Identify potential regulatory risks and implement proactive mitigation strategies.
• Provide subject matter expertise on CMC requirements for both small molecules (NCEs) and biologics (mAbs), including comparability assessments and stability strategies.
• Serve as the primary CMC regulatory representative to the FDA, EMA, and other international health authorities.
• Lead preparation activities for regulatory meetings and represent the organization during agency interactions.
• Author and coordinate responses to health authority questions and requests for information.
• Evaluate the regulatory impact of manufacturing and process changes on global registrations and define appropriate reporting strategies.
• Establish data requirements to support post-approval changes, variations, and supplements.

Regulatory Submissions & Documentation

• Lead the preparation, authoring, review, and delivery of CMC documentation for global regulatory submissions, including:
• NDAs, BLAs, and MAAs supporting product registration in the U.S., Europe, and other key markets.
• Oversee the development and maintenance of the Common Technical Document (CTD), with particular focus on:
• Module 3 (Quality)
• Module 2.3 (Quality Overall Summary)
• Ensure submissions meet regulatory expectations, maintain technical accuracy, and remain aligned across regions.

Cross-Functional Collaboration

• Partner closely with Process Development, Analytical Development, Manufacturing, and Quality functions to ensure data quality, regulatory readiness, and submission success.
• Provide regulatory assessments and strategic guidance for manufacturing-related decisions, including site transfers, technology transfers, and scale-up initiatives.
• Monitor evolving global CMC regulations, industry trends, and agency expectations, translating regulatory requirements into practical business strategies.
• Serve as a trusted regulatory advisor to internal stakeholders and senior leadership teams.

Qualifications

• BS or MS degree in Chemistry, Biology, Pharmacy, or a related scientific discipline; PhD or PharmD preferred.
• Minimum of 10 years of biopharmaceutical industry experience, including at least 7 years in CMC Regulatory Affairs.
• Proven experience supporting at least one major marketing application (NDA, BLA, or equivalent) through preparation, submission, review, and approval.
• Strong working knowledge of GMP regulations, ICH guidelines, and global regulatory frameworks.
• Deep expertise across both small molecule and monoclonal antibody development programs.
• Ability to interpret complex scientific and technical data, including impurity profiles, dissolution studies, analytical characterization, and mass spectrometry results, and translate findings into clear regulatory narratives.
• Comprehensive understanding of FDA, EMA, ICH, and other international regulatory requirements.
• Excellent communication, presentation, and stakeholder management skills, with the ability to influence across cross-functional teams, senior leadership, contract manufacturers, and regulatory agencies.
• Must be available to work onsite a minimum of four days per week.