Looking for Team Member FDA Co-ordination / Research Work.
1. Checking product labels/ artwork of all Cipla products as per the labelling requirements of Indian rules, to ensure compliance with regulatory requirements
2. Preparing applications for Test license NOC, Export NOC, Additional product approval, COPP & WHO-GMP approvals
Accountability Cluster & Major Activities / Tasks
Timely approval of Copy matter checklist (CMCL) of product labels. (Local & Export market)
Issue FDA product license to packaging dept which is required to upload in CMCL system
Check product label as per labelling rules (D&C Act) and provide final sigh off to print artworks after clearance from CQA dept)
Schedule Confirmation: Confirmation of respective Products w.r.t. its schedule G / H / H1.
Verifying product label artworks offline through email for confirmation of labelling matter (3rd party locations)
Check product label with labelling rules
Preparing and submission of FDA license applications for additional products, Test license NOC, Export NOC, COPP & WHO-GMP approvals
Collect required documents from internal stakeholders
Compile license application in format as prescribed by respective authority for submission
Provide product license, Mfg. License, neutral code license or test license to internal stake holder as per the requirements for new or additional products. Providing available license copy to internal stake holders by same day.
Everyday follow-up with plant location for draft license & product license on regular basis.
Obtaining timely acknowledgement for artwork approval from unit /research work FDA/Regulatory
6. Key Interactions
Packaging dept, regulatory division, manufacturing unit.
Contract Manufacturing Sites w.r.t. FDA Licence application.
1. On an average 15-20 drug license applications
2. 400-600 CMCL- artwork approvals monthly
3. Research work/Regulatory/Policy
8. Key Decisions:
Implementing regulatory changes or up-gradation effectively on product label
Make & arrange to submit FDA applications to the respective Licensing authorities in the desired format of respective state / central drug department.
Resolving any technical queries raised by respective stakeholders in consultation with Reporting manager as and when required.
9. Skills & Knowledge:
B.Sc./ B.Pharm / Communication / Agency / PR firm.
Threshold skills and capabilities required to execute the role
Good communication skill.
Knowledge of online applications
Research work / PR role
2-3 years of experience
Its an Offroll Position.
Interested candidates can mail their resume on firstname.lastname@example.org
Cipla Pharmaceuticals Ltd
Perks and BenefitsAs per company norms
Salary: INR 1,75,000 - 3,00,000 PA.
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager
Employment Type:Full Time, Permanent
Desired Candidate Profile
UG:Any Graduate - Any Specialization, B.Pharma - Pharmacy, B.Sc - Any Specialization
Recruiter Name:Ms. Catherine Coelho
Contact Company:Cipla Ltd