Regulatory Affairs Manager
Vor 5 Tagen
OmniVision GmbH is a leading non-corporate ophthalmology company with a strong presence in Germany and a growing network of locations in Austria, Italy, Spain, and Switzerland.
Job SummaryWe are seeking a highly motivated and experienced Regulatory Affairs Manager to join our headquarters in Puchheim near Munich. As a key member of our Regulatory Affairs team, you will be responsible for planning, coordinating, and submitting marketing authorization dossiers for ophthalmological products.
Key Responsibilities- Marketing Authorization Dossiers: Plan, coordinate, and submit marketing authorization dossiers for ophthalmological products with chemically defined substances.
- Regulatory Strategy Development: Develop and implement regulatory strategies to ensure compliance with EU regulations.
- Regulatory Due Diligence: Review marketing authorization dossiers for in-licensing and planned marketing authorization transfers.
- Regulatory Activities Coordination: Coordinate regulatory activities across OmniVision subsidiaries in Austria, Italy, Spain, and Switzerland.
- Scientific Advice: Plan, prepare, and conduct scientific advice meetings with regulatory authorities.
- Regulatory Database Management: Maintain and update the company's internal authorization database.
- Team Leadership: Serve as deputy head of the Regulatory Affairs department and lead a team of regulatory professionals.
- Education: University degree in natural sciences, preferably Pharmacy, Biology, or Chemistry.
- Experience: At least 5 years of professional and practical experience in regulatory affairs within the EU.
- Skills: Sound knowledge of EU/ICH regulatory guidelines and regulations, open-minded personality, ability to lead a team, service-orientation, analytical thinking, and excellent communication skills.
- Language: Fluent in German and English with excellent oral and written communication skills.
- Software: Excellent knowledge of Microsoft Office suite and experience in creating eCTD dossiers and maintaining Regulatory Information Management Systems (RIMS).
- Permanent Position: A permanent, long-term position in a successful, owner-managed medium-sized company in the pharmaceutical industry.
- Attractive Remuneration: An attractive remuneration package.
- Training Opportunities: Training opportunities for professional growth and development.
- Benefits: 30 days annual leave, flexible working hours, modern IT infrastructure, modern offices with employee parking, subsidized company meals, financial support for a job bike, payment of Germany ticket, and employee discounts.
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