Manager - 2 - Regulatory Affairs
4 weeks ago
Job Summary
Manage work related to Regulatory Affairs functions at Site
.
Areas Of Responsibility
1
Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc.
2
Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.
3
Coordination with CRA, ADD, FDD, MSTG ,PMO ,Plant team and with other CFT Members for regulatory requirements related to Registration, Re-Registration, queries, and variation filing.
4
Product Life Cycle Management: Active participation in Change control committee meeting. – Discussion with different Stakeholders and decision for final variation category (After taking concurrence from CRA, Country RA and Customers if require).
5
Activities related to Variation management - Tracking of Variation filing, approvals and intimation to plant for implementation of changes.
6
Support plant for business continuity of products by filing variations wherever applicable.
7
Monitoring for circulation of Regulatory Approvals and commitment details to Plant Team for US and OAM and Approval package for emerging market.
8
Participation in all launch discussions with plant CFT , business team , CRA to identify gap & mitigation plan.
9
Circulation of Regulatory strategies and Guidelines, wherever applicable
10
Support plant during Regulatory Inspections.
11
Monitoring for Product permissions, test licences and lay out archival activities for Local FDA.
Job Scope
Internal Interactions (within the organization)
Production/ Quality/MSTG/NPQC/CRA/FDD/ADD/PDD
External Interactions (outside the organization)
Customers / Country RA
Geographical Scope
Halol
Financial Accountability (cost/revenue with exclusive authority)
N/A
Job Requirements
Educational Qualification
M.Sc. /B.Pharm/M.Pharm
Specific Certification
N/A
Skills
Believe in Team work,
Leadership Skills
, Communication Skills
Experience
10-12 Years
-
Manager - 2 - Regulatory Affairs
6 hours ago
halol, India SUN PHARMA Full timeJob Summary Manage work related to Regulatory Affairs functions at Site Areas Of Responsibility 1 Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc. 2 Participation in Action plan discussion for queries from different Regulatory...
-
Manager - 2 - Regulatory Affairs
2 weeks ago
halol, India SUN PHARMA Full timeJob Summary Manage work related to Regulatory Affairs functions at Site Areas Of Responsibility 1 Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc. 2 Participation in Action plan discussion for queries from different Regulatory...
-
Manager - 2 - Regulatory Affairs
4 weeks ago
halol, India SUN PHARMA Full timeJob Summary Manage work related to Regulatory Affairs functions at Site Areas Of Responsibility 1 Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc. 2 Participation in Action plan discussion for queries from different Regulatory...
-
ADL- Technology Transfer
1 month ago
halol, India Job Excel Full timePosition Overview: We are seeking a highly skilled person to join the team. The ideal candidate will provide technical expertise and guidance throughout the transfer process, focusing on process optimization, scale-up, and validation within the Analytical Method Development lab.Key Responsibilities: Develop and optimize analytical methods for the analysis...
-
ADL- Technology Transfer
2 months ago
halol, India Job Excel Full timeJob Description Position Overview: We are seeking a highly skilled person to join the team. The ideal candidate will provide technical expertise and guidance throughout the transfer process, focusing on process optimization, scale-up, and validation within the Analytical Method Development lab.Key Responsibilities: Develop and optimize analytical methods...
-
Production Osd- Executive
2 months ago
Halol, India Job Excel Full timeOversee the planning, scheduling, and execution of production activities to meet production targets while maintaining optimal efficiency and cost-effectiveness. Ensure compliance with cGMP (current Good Manufacturing Practices), regulatory requirements, and company policies and procedures. Collaborate closely with cross-functional teams including Quality...
-
ADL (Officer/Sr.Officer/Executive )
2 months ago
halol, India Job Excel Full timeJob Description We are seeking a highly skilled person to join the team in the pharmaceutical industry. The ideal candidate will be responsible for method development and validation, as well as routine and stability analysis utilizing a variety of analytical techniques including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC),...
-
QA - Officer to Manager
4 weeks ago
halol, India Job Excel Full timeResponsibilities: QAOfficer: Execute qualityassurance activities as per standard operating procedures (SOPs)and regulatory requirements.Conductroutine inspections and audits of manufacturing processesfacilities and documentation.Assistin the investigation of deviations nonconformances and customercomplaints.Support in theimplementation of corrective and...
-
Formulation Development Injectables
4 weeks ago
halol, India Job Excel Full timeResponsibilitiesFormulation& Development InjectablesOfficer Assist informulation development and preformulationstudies.Conduct labscale trials andparticipate in scaleupprocesses.Prepare and maintaindetailed lab records.Performinprocess quality checks and assist in stabilitystudies.Collaborate withcrossfunctional teams for seamless productdevelopment....
-
[Apply Now] Manager
3 days ago
Halol, India SUN PHARMA Full timeJob role : Manager QMSLocation : Halol (Vadodara)Responsibilities of the QMS Investigators:-1. Person should be has experienced/ worked in Parenteral formulation operation (Aseptically filled products/ TS products) and QA functions.2. Person should has exposure for handling of investigation related Deviation/ OOS/ OOT/ Incident.3. Person should be has...
-
Formulation Development
3 weeks ago
halol, India Job Excel Full timeJob Description ResponsibilitiesExecutive Develop pellet formulations, ensuring regulatory compliance.Conduct pre-formulation studies and optimize ingredient selection.Execute lab-scale trials and assist in scale-up processes.Maintain detailed records and assist with regulatory documents.Perform quality checks and participate in stability studies.Collaborate...
-
Manager - Qms Investigator
3 weeks ago
Halol, India SUN PHARMA Full timeJob role : Manager QMS Location : Halol (Vadodara)Responsibilities of the QMS Investigators:-Person should be has experienced/ worked in Parenteral formulation operation (Aseptically filled products/ TS products) and QA functions.Person should has exposure for handling of investigation related Deviation/ OOS/ OOT/ Incident. Person should be has experience...
-
Manager - Qms Investigator
2 months ago
Halol, India SUN PHARMA Full timeJob role : Manager QMS Location : Halol (Vadodara)Responsibilities of the QMS Investigators:-Person should be has experienced/ worked in Parenteral formulation operation (Aseptically filled products/ TS products) and QA functions.Person should has exposure for handling of investigation related Deviation/ OOS/ OOT/ Incident. Person should be has experience...
-
Manager - QMS Investigator
2 months ago
Halol, India SUN PHARMA Full timeJob role : Manager QMSLocation : Halol (Vadodara)Responsibilities of the QMS Investigators:-Person should be has experienced/ worked inParenteral formulationoperation (Aseptically filled products/ TS products) and QA functions.Person should has exposure for handling of investigation related Deviation/ OOS/ OOT/ Incident.Person should be has experience about...
-
Manager - Qms Investigator
2 days ago
Halol, India SUN PHARMA Full timeJob role : Manager QMS Location : Halol (Vadodara) Responsibilities of the QMS Investigators: Person should be has experienced/ worked in Parenteral formulation operation (Aseptically filled products/ TS products) and QA functions. Person should has exposure for handling of investigation related Deviation/ OOS/ OOT/ Incident. Person should be has experience...
-
Manager - QMS Investigator
3 weeks ago
Halol, India SUN PHARMA Full timeJob role : Manager QMSLocation : Halol (Vadodara)Responsibilities of the QMS Investigators:-Person should be has experienced/ worked inParenteral formulationoperation (Aseptically filled products/ TS products) and QA functions.Person should has exposure for handling of investigation related Deviation/ OOS/ OOT/ Incident.Person should be has experience about...
-
Formulation Development
1 month ago
Halol, India Job Excel Full timeResponsibilitiesExecutiveDevelop pellet formulations, ensuring regulatory compliance.Conduct pre-formulation studies and optimize ingredient selection.Execute lab-scale trials and assist in scale-up processes.Maintain detailed records and assist with regulatory documents.Perform quality checks and participate in stability studies.Collaborate with...
-
Formulation Development
4 weeks ago
Halol, India Job Excel Full timeResponsibilitiesExecutiveDevelop pellet formulations, ensuring regulatory compliance.Conduct pre-formulation studies and optimize ingredient selection.Execute lab-scale trials and assist in scale-up processes.Maintain detailed records and assist with regulatory documents.Perform quality checks and participate in stability studies.Collaborate with...
-
Manager - QMS Investigator
2 months ago
halol, India SUN PHARMA Full timeJob role : Manager QMSLocation : Halol (Vadodara)Responsibilities of the QMS Investigators:-Person should be has experienced/ worked in Parenteral formulation operation (Aseptically filled products/ TS products) and QA functions.Person should has exposure for handling of investigation related Deviation/ OOS/ OOT/ Incident.Person should be has experience...
-
Manager - QMS Investigator
3 weeks ago
halol, India SUN PHARMA Full timeJob role : Manager QMSLocation : Halol (Vadodara)Responsibilities of the QMS Investigators:-Person should be has experienced/ worked in Parenteral formulation operation (Aseptically filled products/ TS products) and QA functions.Person should has exposure for handling of investigation related Deviation/ OOS/ OOT/ Incident.Person should be has experience...