Associate General Manager - Regulatory Affairs

Unichem Laboratories Limited

Required skills

Website: unichemlabs.com
Job details:

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.

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