Grab the opportunity To Work with Glenmark Pharmaceuticals

Jobs

 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. 



Vacancy Details:

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

Click here for Official notification and Apply