Associate General Manager - Regulatory Affairs

Unichem Laboratories Limited; Mumbai; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

Unichem Laboratories Limited in Mumbai is seeking a Regulatory Affairs professional to own end-to-end dossier submissions for Brazil, Latin America and ROW, ensuring timely delivery and strict compliance. You will coordinate with QA, production, medical and commercial teams to review technical documents and manage registrations.

The role requires experience in regulatory inspections, strong compliance knowledge, and proven leadership to guide a team across cross-functional projects and multiple

Qualifications

• Experience handling regulatory submissions for Brazil, Latin America and ROW.
• Experience with regulatory inspections.
• Team leadership experience is required.
• Strong compliance knowledge is essential.
• Proactive approach to queries and problem solving is needed.
• Ability to coordinate with multiple stakeholders and cross-functional teams.

Responsibilities

• Ensure timely dossier submission across Brazil, Latin America and ROW per guidance.
• Handle queries from agencies, customers, and variations of technical agreements.
• Facilitate lifecycle management activities as per guidelines.
• Coordinate with QA, QC, production, medical, commercial and other departments.
• Review MPRs, specifications, COAs, validations to minimize queries.
• Approve packaging documents like specs and test procedures.
• Interact with agents, distributors, customers for registrations and lifecycle mgmt.
• Update and maintain registration databases and status reports.
• Manage EMS system for export orders and registration status updates.
• Organize and monitor department SOP training.
• Monitor administrative duties and DCGI submissions.
• Oversee subordinates' performance and development.

Skills

Brazil submissions

Latin America submissions

ROW submissions

Regulatory inspections

Team leadership

Compliance knowledge

Stakeholder management

Proactive problem solving

Attention to detail

Job description

• 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.