Walk in for Executive / Senior Executive Regulatory Affairs (US Market)
Experience : 3 to 15years
Qualification : M. Pharm/ M.Sc
Roles and Responsibilities :
The compilation of ANDAs, and ensure for timely submission to USFDA. Preferred for Solidoral / Topical / Gel.
The assessment for outsourced DMFs
Review of Technical documents received from manufacturing site such as development reports, BMR, BPR, specifications, method validation, process validation, change control etc.
Coordinating with R&D, QA, Production, ADL and Purchase for collection of Technical data for the compilation as per the guidelines
To ensure timely response of deficiencies raised by Agency on ANDA’s
Handling of Change Controls and deviations for their impact on respective regulatory submission.
Review, compilation and authoring of CMC, Bio Pharmaceutics, Labeling, Module 1 documents.
Authoring and review of ANDA dossier/deficiencies in eCTD format.
Time and venue :
18th Dec, 2021
10.00 AM – 3.00 PM
Alkem Laboratories Ltd (R&D), C-6/1 C-6/2 C-17/7, Dist, Industrial Estate, Opposite Taloja Police Station,Taloja, Navi Mumbai, Maharashtra 410208
Contact – Snehal Parkhi (HRD)
All the candidates interested to attend walk in are requested to take adequate COVID protection measures as per the government norms.
- Advance Your Career in Pharmaceuticals at Brooks Steriscience: Apply Now
- Walk-In Interviews at Ananta Medicare on 30 November & 01 December 2024: OSD and Sterile Pharmaceutical Manufacturing Roles for Freshers & Experience
- Advance Your Career with Indoco Remedies – Sterile Formulations Walk-In Interviews on 24th November & 1st December, 2024
- Medpace now hiring for eClinical Coordinator at Navi Mumbai, India
- Research Associate I – Advarra Freshers Hiring | Bengaluru, India
