Regulatory CMC Technical Lead Consultant

This is a fully remote position, open to applicants in Italy.

📋 Description

• Maintain or develop CMC regulatory documents for specific products to facilitate submissions to Regulatory Authorities.

• Oversee CMC regulatory documents in partnership with the Core team, assuming full responsibility without supervision.

• Serve as the CMC representative at the core team level globally, as needed.

• Write and/or review CMC sections for new marketing authorization applications, investigational applications, and variations/supplements on a global scale.

• Provide guidance to multidisciplinary project teams regarding regulatory agency requirements and expectations for CMC submission dossier sections.

• Evaluate and review change control requests related to CMC aspects of products.

• Collaborate on regulatory strategy for product lifecycle and development with CMC functions.

• Manage submission information in the document management system while tracking regulatory CMC commitments and timelines with minimal oversight.

• Work alongside external CMOs and cross-functional teams on process optimization, scale-up, and technology transfer initiatives.

• Negotiate strategies and actions with regulatory agencies concerning CMC submission dossier sections.

• Assist in process development and the creation of Standard Operating Procedures.

• Support due diligence efforts on CMC regulatory documents.

• Represent the company during GMP inspections by regulatory authorities, when necessary.

• Stay updated on regulations, policies, guidelines, and changing regulatory CMC requirements.

⛳️ Requirements

• A minimum of a bachelor’s degree in a Scientific or Technical Discipline.

• At least 5 years of experience in Regulatory CMC with a focus on small molecule drug development.

• Additional experience with biologics and Antibody-Drug Conjugates (ADCs) is highly desirable and seen as a significant advantage.

• Advanced understanding of current global CMC regulations, including ICH guidelines and US/EU regulatory requirements.

• Solid knowledge of regulatory requirements for manufacturing technical transfer and comparability.

• Experience in authoring technical documents, including CTD M2 and M3 sections, and managing quality variations throughout their lifecycle.

• Proficient in quality management software (e.g., TrackWise) and regulatory document information management systems.

• Exceptional attention to detail.

• Ability to manage multiple tasks, stay organized, and prioritize effectively.

• Strong communication skills, both oral and written, as well as interpersonal abilities.

• Critical thinking skills to identify issues and recommend viable solutions.

• Capacity to work independently and collaboratively within a team.

• Ability to excel in a high-paced work environment.

🏝️ Benefits

• Ongoing training and opportunities for professional development.

• Commitment to equal opportunity employment.

• A workplace that values diversity and inclusivity.