[Hiring] Regulatory CMC Technical Lead Consultant @ClinChoice

Role Description

Maintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities.

• Manage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team, with full responsibility and no need of supervision.
• Act as the CMC representative at core team level with a global role, where required.
• Author and/or review CMC sections of the dedicated portfolio for new marketing authorization applications, investigational applications and variations/supplements, worldwide.
• Advise multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossier.
• Review and assess change control requests pertaining to CMC aspects of product(s).
• In alignment with CMC functions, agree on the regulatory strategy for the products life cycle and development.
• Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision.
• Work collaboratively with external CMOs and cross-functional teams on projects like process optimizations, scale up and technology transfer activities.
• In agreement with CMC functions and collaborating with region functions, negotiate with regulatory agencies strategies and actions on CMC sections of submission dossier.
• Support the development of processes and to the preparation of Standard Operating Procedures where required.
• Support due diligence activities on CMC regulatory documents, where required.
• Represent during GMP inspections by regulatory agencies, where required.
• Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements.

Qualifications

• Minimum of a bachelor’s degree in a Scientific or Technical Discipline.
• Minimum of 5 years of experience in Regulatory CMC focusing on small molecule drug development.
• Additional experience with biologics and Antibody-Drug Conjugates (ADCs) is highly desirable and considered a strong advantage.
• Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements.
• Sound knowledge of manufacturing technical transfer and comparability regulatory requirements.
• Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations.
• Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system.
• Strong attention to detail. Ability to multi-task, stay organized and prioritize.
• Strong communication skills (oral, written and interpersonal); critical thinking and the ability to identify and recommend solutions to problems.
• Ability to work independently and in a group setting and thrive in a fast-paced environment.

Company Description

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!