• Caplin Point
    Providing remedies
    BRINGING SMILES to people
  • We Choose To Be
  • We always took
    the road less travelled and
    that has made ALL THE DIFFERENCE


  • Job Posted On 19/08/2016

Designation : Dy. Manager

No of Positions : 1

Edu. Qualification : M.Sc

Experience : 10-15 Years

Work Location : Gummidipoondi, Injectable plant

Requirements : M. Pharm, M.Sc. having 15+ years of experience with sterile / formulation unit, having experience and strong exposure in regulated markets and skill in facing / handling regulated audits. Candidate should have expertise knowledge in USFDA regulations and compliances. Should have good command over English and documents filling, Should be a very good team player, to lead a team. Should have open mind to interact with all the cross functional teams.

Responsibility :

1.Preparation of CTD/eCTD dossiers for various regulatory agencies.
2.Review of SOPs related to Regulatory submissions.
3.Co-ordination with various departments like production, QA, QC, R&D for Regulatory documents.
4.Review of specifications, STP and COA to make in line with USP, Ph.Eur.
5.Review of protocol and report as per Regulatory aspects (eg. Stability, Analytical method validation etc.)
6.Review of Drug master File (DMF)
7.Preparation of database for various regulatory guidelines.
8.Maintaining matrix for different products as per the requirements of different, Regulatory agencies and providing training on Regulatory requirements.
9.Preparation of documents for NOC, Test license, Import license and Manufacturing licenses.
Candidates having injectable / Formulation background are highly preferred. Candidates must be self motivated with excellent written and verbal communication skills. Good interpersonal and project management skills are critical for this position.

The file size should be less than 1mb and it should be a doc,docx or a pdf file.