Glenmark Pharmaceuticals Released Job Openings On 16-11-2021. Glenmark Pharmaceuticals Limited is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977.. Application form link provided at the end of post.
Vacancy Details:
Glenmark Pharmaceuticals Recruiting B.Pharm/ M.Pharm Graduate with 2 to 4 years of Experience for Sr. Officer – Regulatory Affairs Position.Complete Details for the Sr. Officer – Regulatory Affairs as follows.
Important Details :
- Location : Baddi
- No of Vacancies:02
- Details of Salary: NA
- Opening date for online Application: 16-11-2021
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
Strong & in-depth review of Technical data required for new registration & deficiency response.
(i) API data: Thorough DMF review & complete understanding of ICH guidelines/understand intricacies of impurity profiling and impact, API-specifications and methods/detailed understanding of AMV requirements and parameters included/stability/Photostability and Forced degradation, etc.
(ii) FP data: Thorough review of FP data such as PDR/Process Validation/ understand intricacies of impurity profiling of FP w.r.t. API & their impact, FP-specifications and methods/detailed understanding of AMV requirements and parameters included/ stability/Photostability and Forced degradation, etc.
(iii) Knowledge w.r.t. Dermatology/cosmetic products and OSDs
- Knowledge of Country specific requirements for Emerging Markets – regions: Asia/ Africa / Middle East/ Latam and Russia-CIS & Dossier compilation as per eCTD/CTD/ACTD/Country Specific formats for product Registration.
- Correct interpretation, communication & closure of deficiencies, from country counterparts, consultant and MoH on priority & maintain overall query status
Strong Communication for
(i) Correct interpretation of guidelines & requisition of data such as Administrative data / Technical data for API & FP/Artworks/Samples/WS/Raw materials/Clinical/Non-Clinical / Pharmacovigilance from various from cross-functional departments viz., Sourcing/R&D/Plant-QA/QC/Medical/PV / Packaging required for registration & deficiency replies.
(ii) Communicate with regional counterparts for registration/queries requirement.
- Maintain dossier submission, filing, approval & deficiency, new launch status
- Satisfactory regulatory support to Asia, Africa, Russia and CIS, and Brazil and other Latam countries
- Satisfactory regulatory support to R & D / BD/Marketing/ CQA/ QA/ PDD/ Purchase
- Facilitate launch within 60 days : Timely initiation of change control and closure, release of registration profile, creation & revision of artworks
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