Associate General Manager - Regulatory Affairs

Unichem Laboratories; Mumbai Suburban; On-site; INR 1,800,000 - 3,400,000; Full time

Job summary

Unichem Laboratories seeks a regulatory affairs professional to manage submissions for Brazil, Latin America, and ROW, ensure adherence to timelines, and coordinate across QA, production, and regulatory teams. You will handle agency queries, support lifecycle management, and interact with distributors and customers to secure registrations.

The role requires strong knowledge of regulatory requirements, excellent communication, and the ability to lead cross-functional efforts in a dynamic

Qualifications

• Should have strong experience in handling regulatory submissions for Brazil, Latin America and ROW.
• Experience with regulatory inspections and audits is required.
• Ability to lead teams and coordinate across multiple functions.

Responsibilities

• Ensure final submission of dossiers for Brazil, Latin America, Europe and ROW within timelines.
• Handle queries from agencies, customers and variations of technical agreements.
• Facilitate lifecycle management activities as per current guidance.
• Coordinate with QA, QC, production and cross-functional teams.
• Review technical documents (MPRs, COAs, validations) to minimize queries.
• Approve packaging documents (specifications, SOPs).
• Interact with agents, distributors and customers for registrations and lifecycle management.
• Maintain registration databases and monthly reports.

Skills

Regulatory submissions

Brazil submissions

Latin America

Regulatory inspections

Team leadership

Compliance knowledge

Stakeholder management

Communication skills

Job description

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.