Associate General Manager - Regulatory Affairs

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.
• High standards of business ethics, integrity, confidentiality, attention to detail, and compliance.
• Should be willing to work in dynamic environment.