Remote Senior Regulatory CMC Lead for Global Submissions

ClinChoice; United States; À distance; USD 140 000 - 210 000; Plein temps

Avantages offerts par ce poste

Remote work flexibility

Résumé du poste

ClinChoice is seeking a Regulatory CMC Technical Lead Consultant to manage and author CMC regulatory documents for global submissions. You will collaborate with the Core team, act as the CMC representative in cross-functional settings, and advise project teams on regulatory expectations.

The role requires strong knowledge of ICH and US/EU CMC regulations, experience with CTD M2/M3, and ability to work independently in a fast-paced environment. Remote options available.

Qualifications

• Bachelor’s degree in a Scientific or Technical discipline.
• Minimum 5 years of experience in Regulatory CMC for small molecule drug development.
• Experience with biologics/ADC is highly desirable.
• Advanced knowledge of global CMC regulations (ICH, US/EU).
• Experience authoring CTD M2/M3 and lifecycle management of variations.
• Proficient with quality management software and regulatory information systems.

Responsabilités

• Maintain or create CMC regulatory documents for dedicated products.
• Manage CMC regulatory documents in collaboration with the Core team with full responsibility.
• Act as CMC representative at core team level with a global role when required.
• Author/review CMC sections for new marketing authorizations, submissions worldwide.
• Advise multidisciplinary teams on regulatory agency requirements for CMC submissions.
• Review and assess CMC change control requests.
• Agree on regulatory strategy for product lifecycle and development.
• Maintain submission information and track CMC commitments and timelines.
• Collaborate with external CMOs and cross-functional teams on process improvements and tech transfers.
• Represent during GMP inspections and stay updated on evolving CMC regulations.

Connaissances

CMC regulatory knowledge

Regulatory strategy

Communication skills

Attention to detail

Multi-tasking

Independent work

Cross-functional collaboration

Formation

Bachelor’s degree in science or engineering

Outils

TrackWise

Regulatory DMS

Description du poste

ClinChoice is seeking a Regulatory CMC Technical Lead Consultant to manage and author CMC regulatory documents for global submissions. You will collaborate with the Core team, act as the CMC representative in cross-functional settings, and advise project teams on regulatory expectations.

The role requires strong knowledge of ICH and US/EU CMC regulations, experience with CTD M2/M3, and ability to work independently in a fast-paced environment. Remote options available.