Regulatory Affairs Specialist
As part of the Regulatory Affairs team, the Regulatory Affairs Specialist enables the adoption and use of biotechnology products, including single use technologies, filtration devices for medical, food & beverage and drinking water applications and products for advanced therapies and cell culture media. This is achieved by supporting R&D, Engineering, Sales, Supply Chain, Marketing, and other internal functions on issues related to quality and regulatory compliance. The ideal candidate will advise project teams on subjects such as customer requirements, material compliance, labeling requirements, shelf life, registration, permits and sterility to assure products meet requirements for global sale. The Regulatory Affairs Specialist also provides support to customers requesting regulatory and quality documents for product approval. The regulatory focus will be on the Asia market with the major applications: Food Contact Materials, Drinking Water, Equipment/Systems for Pharma and Medical Devices.
The Regulatory Affairs Specialist will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The holder of this position will organize regulatory information and is able to interpret regulations for relevant stakeholders, collate track and control submissions and provide guidance and advice to internal stakeholder.
The holder of the position will be responsible as the contact for the authorities.
Main Responsibilities & Tasks:
- Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
- Provide expert regulatory input to strategic decision making; including review, prioritization, and external communications
- Support the development and establishment of procedures, policies and standards
- Coordinate successful submissions and approval of applications
- Plan, undertake and oversee regulatory inspections
- Liaise and negotiate with regulatory authorities
- Provide advice about regulations to relevant stakeholder
- Review and report overall quality status
- Keep up to date with changes in regulatory legislation and guidelines
Qualifications & Skills:
- Bachelor’s degree in a science or related field
- 5+ years relevant experience within the Regulatory Affairs discipline
- Deep knowledge of the relevant Regulatory requirements for devices/products listed above
- Thorough understanding and demonstrated ability to apply Regulatory guidelines/regulations
- Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources
- Proven analytical skill and technical/scientific competence
- Attention to details and ability to appropriately assess risks
- Strong initiation and organizational skills
- Excellent communication skills, with ability to influence others and negotiate successful outcomes
- Proactive, quick learner and independent worker able to effectively multi-task in a strongly growing organisation
- Team-player, able to positively influence Team members at all levels
- Fluent in English
Ready to join Sartorius?
Sartorius ist Teil der Lösung im Kampf gegen Krebs, Demenz und viele andere Krankheiten. Unsere Technologien helfen wissenschaftliche Erkenntnisse schneller in Medikamente für Patienten weltweit zu übersetzen.
Wir suchen ambitionierte Teamplayer und kreative Köpfe, die zu diesem Ziel beitragen und ihre Karriere in einem dynamischen globalen Umfeld vorantreiben wollen. Werden auch Sie Teil der Lösung. Wir freuen uns auf Ihre Bewerbung.
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Unterschiedliche Perspektiven und neue Ideen sind entscheidend, um Fortschritte in den Life Sciences und der Bioprozesstechnik zu vereinfachen, damit Menschen weltweit schneller Zugang zu neuen Therapien erhalten.
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