Associate General Manager - Regulatory Affairs

About the Company

Responsibilities

• ● Ensure final submission of the dossier in Brazil; Latin America; Europe and ROW (Rest of World) market in line with current guidance and achieved within the timeline.
• ● Handle queries from agencies and customers and variations of technical agreements etc.
• ● Facilitate and ensure life cycle management activity as per current guidance.
• ● Coordinate with departments such as ACASIA, FDA, FD, medical, commercial, packaging development, project management & manufacturing location such as QA, QC, production, etc.
• ● Review technical documents such as MPRs, specifications, COAs, process validations, method validations, stability, etc. to ensure minimum queries on these parts of the dossier.
• ● Approve packaging documents such as specifications, standard test procedures, etc.
• ● Interact with agents, distributors, customers, consultants etc. for new registration and life cycle management of registered products.
• ● Update & maintain registration database, product & company registration status, monthly report, capex, and budget.
• ● Handle the EMS system for export order forwarding & update the registration status.
• ● Organize and monitor departmental SOP training.
• ● Monitor administrative job responsibility.
• ● Monitor DCGI submission for new drug applications.
• ● Monitor the performance of sub-ordinates.
• ● Desired Skills
• ● Should have strong experience in handling regulatory submissions for Brazil, Latin America and ROW
• ● Should have strong experience in regulatory inspections.
• ● Should have team handling experience.
• ● Knowledge of compliance must be strong.
• ● Proactive approach to queries, with strong problem-solving, decision-making, and communication skills.
• ● Ability to manage multiple stakeholders, lead teams, and work effectively across functions.