Glenmark Pharmaceuticals Released Job Openings On 02/12/2022. Glenmark Pharmaceuticals Limited is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977.Eligibility Criteria / Educational Qualification, Official Notification, Apply Online Form Link & Other Relevant Details for Glenmark Pharmaceuticals Recruitment 2022 are provided below. Interested and eligible candidates can submit application along with resume.
Glenmark Pharmaceuticals Recruiting M.Pharma with 08 to 10 years of experience for Assistant Manager – Regulatory Affairs (Respiratory) Position.Complete Details for the Assistant Manager – Regulatory Affairs (Respiratory) as follows.
Important Details :
- Location : Mumbai
- No of Vacancies:01
- Details of Salary:NA
- Opening date for online Application: 02/12/2022
- 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
This position will be responsible for –
- Timely submission and review of assigned submission for Regulated Markets i.e. US, EU, Canada, AUS of Respiratory Products.
- Approval of change controls and specifications for raw materials and finished product.
- Evaluation and submission of controlled correspondences/ scientific meetings.
Roles and Responsibilities
- Strong review of Technical data required for compilation & submission as per US, EU, Canada and AUS regulatory requirements
(i) API data: Thorough DMF review & complete understanding of ICH format/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. Respiratory (Inhalation Solution/Suspension, Nasal Spray, MDI, DPI)
products regulated market filing is essential
(iv) Regulatory filing strategy as per current USFDA, EMA, TGA and Canada guidance