5 дней назад
GRA S&P Junior Manager (Regulatory Affairs)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
GRA S&P Junior Manager (Regulatory Affairs): Preparing and coordinating regulatory submissions, registrations, renewals, variations, and lifecycle documentation for healthcare products with an accent on regulatory compliance, document accuracy, and cross-functional coordination. Focus on managing submission deadlines, communicating with local and global regulatory teams, and tracking approvals, certificates, translations, samples, and standards.
Location: Hybrid work based at the Sânandrei, Timiș County, Romania office, with 50–60% of work performed from home. Regular travel to Sempach, Switzerland, once or twice per year.
Company
develops healthcare solutions focused on protecting and improving people’s health worldwide.
What you will do
- Prepare, check, and submit registration and market-maintenance documents, including variations, renewals, and new registrations.
- Prepare regulatory documents in collaboration with product owners and relevant departments.
- Obtain certificates and legalizations, arrange translations, and coordinate the dispatch of regulatory dossiers.
- Monitor regulatory procedures, maintain documentation and correspondence, and track deadlines.
- Communicate approval or rejection outcomes and related documents to involved departments and local representatives.
- Coordinate with Local Regulatory Affairs teams and global functional groups, including the dispatch of required samples and standards.
Requirements
- University degree in Pharmacy, Medicine, Chemistry, Biology, or a related field.
- 1–2 years of professional experience in regulatory affairs.
- Fluent written and verbal English.
- Proficiency in Microsoft Office and strong organizational skills with attention to detail.
- Analytical, systematic, responsible, adaptable, and committed working style.
- Strong communication, teamwork, flexibility, and resilience.
Nice to have
- Postgraduate studies in a relevant field.
Culture & Benefits
- Unlimited-period employment contract.
- Annual performance bonus.
- Meal tickets and a health subscription with free or discounted medical services.
- Wellhub subscription and partial reimbursement for eyeglasses.
- Family-event premium according to the Collective Labor Agreement.
- Free coffee and a dynamic working environment.
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