Regulatory CMC Technical Lead Consultant

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 to 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.

Requirements

• 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.
• Who will you be working for?
• About ClinChoice
• 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!
• Our Company Ethos
• Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
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