Manager

This position willbe responsible for regulatory product registration filings in key markets including Canada, UK/EU and AU and willneed to supportUS filings as required. The role will involve compilation of dossiers for filing in key markets, responding to queries from the regulatory agencies, and interacting withstakeholders. This position will also be

responsible for managing regulatory communications with HealthCanada.

AGM/GM – Regulatory Affairs (Key Markets)

10-12 years

• Compilation of dossiers for filings in key markets including Canada, UK/EU and AU for generic and new products.
• Responding to queriesfrom regulatory agencies.
• Co-ordinate with stakeholders and cross-functional team for filing documents and data.
• Manage product registration filings in key markets.
• Manage communications withHealth Canada.
• Manage meetings anddiscussions with HealthCanada.
• Support as needed, US filings in the pre-approval or post approval space.
• Coordinate with globalregulatory teams.
• Ensure business growthand operational excellence within regulatory setup.

• B.S/M.S in Pharmaceutical Sciences
• Proficiency in Regulatory Affairs.
• Knowledge about Pharmaceutical Product Development.
• Excellent communication, planning, analytical and interpersonal skills.
• Prior work experience with Health Canadais preferred.