DRA

Preparation of text matter for artworks, Labels. Review and Approval of Artworks, change controls and updating for all Regulatory Submissions.

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.

Understanding the Global regulations like CLP, GHS etc. and creating compliant Safety Data Sheets by doing intensive data search and evaluating proper data.

Formulation Production Experience - Bottle Packing Section Oral solid manufacturing, Sterilization, Granulation, coating and documentation as per SOP.