обновлено 48 минут назад
Senior Manager, CMC Regulatory Affairs, Global Rare Diseases
121 000 - 182 000$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, CMC Regulatory Affairs, Global Rare Diseases (CMC Regulatory Affairs): Managing global CMC regulatory documentation and strategies for commercial rare-disease products with an accent on worldwide submissions, lifecycle management, and regulatory agency engagement. Focus on authoring CTD M2 and M3 sections, supporting technical transfers and comparability assessments, and coordinating CMC activities with cross-functional teams and external CMOs.
Location: Hybrid role based in the Cary, NC office, United States
Salary: $121,000–$182,000 annual base pay
Company
is an international research-focused biopharmaceutical group operating in 31 countries, with a Global Rare Diseases business unit focused on treatments and patient support services for rare and ultra-rare disorders.
What you will do
- Create, maintain, author, and review CMC regulatory documents for global submissions, including marketing authorization applications, investigational applications, and variations or supplements.
- Represent CMC Regulatory Affairs on core teams and advise multidisciplinary project teams on regulatory authority requirements for CMC dossier sections.
- Develop regulatory strategies for product development and lifecycle management, including change controls, commitments, timelines, and quality variations.
- Collaborate with regional regulatory functions, cross-functional teams, and external CMOs on process optimization, scale-up, manufacturing technology transfer, and comparability activities.
- Engage with regulatory agencies on CMC strategies and actions and represent Regulatory Affairs during GMP inspections when required.
- Support standard operating procedures, due diligence activities, and regulatory document management processes.
Requirements
- Bachelor’s degree in a scientific or technical discipline.
- At least 5 years of Regulatory CMC experience.
- Advanced knowledge of global CMC regulations, including ICH and US/EU requirements.
- Experience with manufacturing technical transfer, comparability requirements, CTD M2 and M3 sections, and quality variation lifecycle management.
- Proficiency with quality management software such as TrackWise and regulatory document information management systems.
- Strong communication, critical-thinking, organizational, prioritization, and independent-working skills.
Nice to have
- Advanced degree in a scientific or technical discipline.
Culture & Benefits
- Access to professional development resources and training.
- Comprehensive healthcare programs and work-life balance initiatives.
- Performance bonuses and benefits benchmarked against the external market.
- Relocation support, flexible working arrangements, remote work options, and tax assistance services for foreign colleagues.
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