Team Member FDA Co-ordination/ Research Work at Cipla

0 - 4 Years
Mumbai, Navi Mumbai, Mumbai Suburbs
INR 1,75,000 - 3,00,000 PA.
Posted: 10 days agoOpenings: 2Job Applicants: 2186+Job Views: 4953+

Job Description


Dear Aspirants,

Looking for Team Member FDA Co-ordination / Research Work.


Job Purpose:

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


Accountabilities:

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.

Major Challenges

Obtaining timely acknowledgement for artwork approval from unit /research work FDA/Regulatory


6. Key Interactions


Internal
Packaging dept, regulatory division, manufacturing unit.
External
Contract Manufacturing Sites w.r.t. FDA Licence application.
Licensing authority


7. Dimensions:

1. On an average 15-20 drug license applications
2. 400-600 CMCL- artwork approvals monthly
3. Research work/Regulatory/Policy


8. Key Decisions:

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.
Recommendations
Resolving any technical queries raised by respective stakeholders in consultation with Reporting manager as and when required.


9. Skills & Knowledge:


Educational qualifications:
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


Relevant experience:
2-3 years of experience

Note :
Its an Offroll Position.

Interested candidates can mail their resume on catherine.coelho@cipla.com

Regards,
Catherine Coelho
Human Resources
Cipla Pharmaceuticals Ltd

Perks and Benefits 

As per company norms

Salary: INR 1,75,000 - 3,00,000 PA.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type:Full Time, Permanent

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:Any Graduate - Any Specialization, B.Pharma - Pharmacy, B.Sc - Any Specialization

Company Profile

Cipla Ltd

Cipla is one of the most respected pharmaceutical companies not just in India but across more than 170 countries. Our portfolio includes 2000 products in 65 therapeutic categories with one quality standard globally. Cipla’s turnover in FY13 was 1.5 billion USD.
View Contact Details+

Recruiter Name:Ms. Catherine Coelho

Contact Company:Cipla Ltd

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