Senior Manager, CMC Regulatory Affairs (Biopharmaceuticals)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Manager, CMC Regulatory Affairs (Biopharmaceuticals): Managing CMC regulatory documents and submissions for a global portfolio of rare disease treatments with an accent on pre- and post-approval strategies. Focus on authoring CTD sections, overseeing technical transfers, and ensuring compliance with US/EU and ICH regulations.
Location: Must be based in one of the company's affiliates in Europe
Salary: From €59,040 (based on Italy)
Company
An international research-focused biopharmaceutical group with 90 years of experience, specializing in innovative drugs for rare and ultra-rare disorders.
What you will do
- Create and maintain CMC regulatory documents to support global submissions to Regulatory Authorities.
- Author and review CMC sections (CTD M2 and M3) for new marketing authorizations and variations worldwide.
- Advise multidisciplinary project teams on regulatory agency requirements and expectations.
- Manage change control requests and define regulatory strategies for product lifecycles.
- Collaborate with external CMOs on process optimizations, scale-ups, and technology transfer activities.
- Represent the company during GMP inspections and negotiate strategies with regulatory agencies.
Requirements
- Bachelor’s degree in a Scientific or Technical Discipline (Advanced Degree strongly preferred).
- 7+ years of Regulatory CMC experience.
- 3+ years of experience in Biologics/Biopharmaceuticals (mandatory).
- Advanced knowledge of global CMC regulations, including ICH and US/EU requirements.
- Experience authoring technical documents (CTD M2/M3) and using quality management software like TrackWise.
- Must be based in or able to work from a European affiliate.
Culture & Benefits
- Competitive salary with an annual performance-based bonus scheme.
- Comprehensive benefits package including pension, private medical insurance, and wellbeing programs.
- Flexible working arrangements and remote work options.
- Robust relocation support for eligible candidates.
- Tax assistance services for foreign colleagues and a dynamic, friendly work environment.
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