Opportunity for M.Pharm, B.Pharm in Regulatory Affairs, Production at Sun Pharma

Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.

Post : Regulatory Affairs Executive, Production Manager, Regulatory & Business Executive

Executive - Regulatory & Business Continuity
Location : Baroda
Job Description
• Compilation , review of dossier for US , EU , AU, Canada & IL market for both solid oral and non-oral dosage form
• Review of query response prepared and compiled by regulatory associates
• Manage all the activities pertaining to dossier submission for aforesaid markets .
• Meet the dossier submission and query response timeline as per given target
• Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management
• Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities
• Lifecycle management for US , EU, Canada & IL market
• Single point contacts for all the regulatory submission activities for IL and Palestine markets
Candidate Profile
Educational Qualification : M.Pharm
Experience : 3-6 years

Manager - Production (Injectables)
Location : Halol-1
Job Description
Position Summary
This role is responsible for managing and overseeing critical aspects of the production process, ensuring adherence to quality standards and regulatory compliance.
• Authorize to sign as a doer/ reviewer and approval in following documents
• CAPA, Investigation and UPD closure
• Impact and Risk Assessment, Justification, FMEA
• Any other documents required for the execution of activities
• To involve, prepare, review of Investigation and to give compliance of Investigation
• Handling of incident, investigation, cross functional incident and investigation
• Handling of corrective and preventive action
• Handling of impact analysis and to give compliance of investigation report and UPD
• To undergo functional training, cGMP training or any other training identified as per schedule
• Any other responsibility assigned by department head after ensuring the relevant training status
Candidate Profile
Educational Qualification : B.Pharm / M.Pharm
Experience : Tenure 14+ Years

Executive - Regulatory Affairs
Location : Tandalja - R&D
Job Description
• Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations.
• Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations.
• Preparation, reviewing, timely submission and coordination of implementation of labeling based on FDA notifications and/or RLD labeling updates.
• Coordination of labeling related activities with cross functional teams for timely launch of products.
• Regulatory submission and filings, coordinating final labeling implementation and maintaining labeling artworks using various softwares.
• Communication with third parties or private label distributors to gather needs and requirements of changes/labeling development.
• Evaluation and coordinating with departments for REMS requirement for applications.