Regulatory Affairs Specialist- Temporary (9 Months)
Job Description:
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.
Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging and rewarding careers – we are motivated to make a difference. To reach our full potential we collaborate, and respect and value diverse contributions so that we can grow as an organization and as professionals. Together we can influence the world around us to make life and work better.
Regulatory coordinator (Temporary- 9 months)
Job Role: Carry out of Regulatory submission processes within agreed timelines.
Main Accountabilities
• Compiles and manages regulatory applications for Ferring products to health authorities, which includes new products, product dosage forms, indication. As well as registration maintenance through renewals & variations submissions.
• Provides labelling support and maintaining SPC update in the region. Reviews locally prepared labelling before approval & implementation.
• Ensures the availability and/or prepares regulatory documents and certificates for obtaining rapid approvals.
• Reviews promotional materials developed by the marketing department from a regulatory point of view
Required qualifications and skills:
• Degree in pharmacy
• 1-2 years of practical experience in the regulatory operations.
• Excellent command in English language
• Excellent computer skills and in MS office (Word, Excel, Outlook)
• Know how interaction with authorities and customers