Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines.
Looking for candidates with relevant experience in Regulatory Affairs
Post : Sr. Manager / Manager - Strategic International Expansion – RA
A strong understanding of regulatory affairs principles, guidelines, and processes of ROW Market Compare and evaluate offers from suppliers. Familiarity with the applicable regulations and requirements in the specific industry or country Track orders and ensure timely delivery
Responsible for Authoring and review of dossiers for submission to US, Canada, Europe, Australia, South Africa and other regulated markets. The Company focused on the emerging markets of Latin America, Caribbean, Francophone and Southern Africa and is today one of the leading suppliers of Pharmaceuticals in these regions, with over 2800 product licenses across the globe.
Review quality Dossiers in CTD format for new Generic drug submissions, in-line with the guidance and templates. Compile responses to deficiencies and deficiency management for the given portfolio of products.
Managing the regulatory aspects of projects and products for pre-approval and post approval submissions for biological, new drugs and global and local clinical trials. In addition, participating in project team meetings, by providing regulatory support to ensure compliance with all local requirements.
Masters degree in Life Sciences or equivalence scientific degree with minimum of 5-7 years pharmaceutical industry experience in regulatory affairs with at least 2 years of proven leadership, technical specialist role experience in health authority interactions
Prepare and review the responses to Health Canada requeue and Deficiency Letters in timely manner to ensure prompt regulatory approvals of dossiers under supervision of Deputy Manager.
Masters in Life Sciences. Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labelling