My client is seeking a Director, Regulatory Affairs to join their team and develop and implement regulatory strategies for generic products.
Responsibilities
- Manage regulatory correspondence in the US (OGD,and EU/UK agencies
- Serve as the primary liaison with regulatory authorities
- understanding of the complexities of inhaled drug-device products
Qualifications
- At least 7 years of regulatory experience within the pharmaindustry.
- ANDA submission and labeling experience
- In-depth knowledge of OGD regulatory requirements and standards
- Understanding of the complexities of inhaled drug-device products
