| || 227007BR |
| || SENIOR REGULATORY AFFAIRS SPECIALIST |
| || ALCON |
| || RESEARCH & DEVELOPMENT AL |
| || Belgium |
| || Puurs |
| || ALCON BEL |
| || Research & Development |
| || Full Time |
| || Regular |
| || Novartis is a world leading healthcare company based in Switzerland providing solutions to address the evolving needs of patients worldwide. Novartis is active in more than 140 countries. More than 1,500 people work for Novartis in Belgium. Novartis has one of the biggest development pipelines due to the high level of investment in R&D.
We are currently looking for a talented person to take on the role of Senior Regulatory Affairs Specialist
In this role, your responsibilities will be as follows:
1. Conduct regulatory assessments for product and process change controls for potential impact on regulatory filings.
2. Develop regulatory strategies and contribute to the quality documentation to support product registration in global markets in line with business objectives and customer needs.
3. Provide regulatory support to project teams for development, continuous improvement, and life-cycle management of the surgical products manufactured at Puurs.
4. Provide and/or contribute to the responses to inquires from global health authorities as needed.
5. Support regulatory inspections including management and support of facility preparadeness.
6. Participate in general activities within the department, including improving and implementing integrated regulatory business processes.
7. Build departmental awareness of local regulatory requirements in global markets.
8. Support other global regulatory activities as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
• Strong knowledge and application of FDA and CE mark regulatory requirements for medical devices and/or pharmaceutics that includes new product development and design control activities. Experience in management of global regulatory requirements is desired but not required.
• Demonstrated ability to develop options and pathways for regulatory approvals considering customer and regulatory requirements, risk and business needs.
• Experience in working on diverse project teams to provide regulatory leadership.
• Ability to make decisions related to site regulatory activities with guidance from corporate partners.
| || - Bachelor’s degree required at a minimum, Master’s degree preferred; in fields such as Engineering or Science discipline; Regulatory Affairs Certification.
- Strong working knowledge of medical devices, procedures, and terminology.
- Fluent in Local Languages served by the cluster and English
- Excellent analytical and communication skills, particularly writing skills, are essential.
We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Novartis supports a flexible work-life integration.