4 дня назад
Regulatory Affairs Manager (f/m/d)
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
Regulatory Affairs Manager (f/m/d) (Pharmaceutical Manufacturing): Leading end-to-end regulatory activities for complex client programs at a GMP-regulated manufacturing site with an accent on CMC strategy, regulatory submissions, lifecycle management, and health authority interactions. Focus on coordinating cross-functional regulatory workstreams, managing compliance risks, and delivering high-quality documentation for complex molecules including bioconjugation projects.
Location: Visp, Basel, Switzerland; onsite at the manufacturing site. Relocation assistance is available for eligible candidates and their families.
Compensation: Not specified.
Company
provides life sciences products and services, supporting pharmaceutical, biotech, and complex molecule manufacturing programs.
What you will do
- Lead end-to-end regulatory activities and serve as the Regulatory Affairs Project Lead for assigned Visp client programs.
- Coordinate regulatory workstreams across internal functions and global regulatory networks, managing priorities, timelines, and deliverables.
- Oversee submissions, lifecycle management, health authority interactions, dossier content, briefing packages, and responses to regulatory queries.
- Develop and support CMC regulatory strategies aligned with global requirements, customer expectations, registered dossiers, and procedures.
- Advise customers and internal stakeholders on regulatory risks, changes, deviations, compliance, and operational challenges.
- Strengthen regulatory capabilities, inspection readiness, documentation standards, and continuous improvement at the Visp site.
Requirements
- Academic degree in Chemistry, Biochemistry, Pharmacy, or a related scientific discipline.
- Solid experience in the pharmaceutical, chemical, or biotech industry, preferably in CDMO environments and GMP-regulated manufacturing.
- Experience in Regulatory Affairs, Quality Control, Quality Assurance, or Program/Project Management, with exposure to manufacturing operations.
- Understanding of GMP regulations, quality systems, manufacturing processes, and CMC regulatory requirements.
- Strong stakeholder management, communication, ownership, and accountability skills in cross-functional, client-driven environments.
- Excellent English communication skills are required; German is an advantage.
Nice to have
- Experience with small molecules, conjugates, or related technologies.
- Experience supporting submissions, lifecycle management, change assessments, or health authority interactions.
- Experience with TrackWise, LIMS, Documentum, or Veeva.
Culture & Benefits
- Agile career environment and dynamic working culture.
- Inclusive and ethical workplace focused on responsible business practices.
- Performance-oriented compensation programs and benefits depending on role and location.
- Temporary full-time position for a period of one year.
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