Enaltec Labs – Urgent Openings for Regulatory Affairs – API || Apply Now

Application deadline closed.

Job Overview

  • Date Posted
    March 24, 2022
  • Expiration date
  • Experience
    5 Year
  • Gender
  • Qualification
    Bachelor Degree, Master’s Degree
  • Minimum education
    Graduate, Post Graduate

Job Description

Enaltec was established in 2006 by a group of young and experienced professionals with the specific objective to develop and produce complex, niche molecules, technology driven products at competitive prices, thus providing the critical India advantage to generic formulators across the world. . Enaltec has established world class infrastructure for manufacturing APIS complying with the requirements of regulated and semi regulated markets. All the labs are GLP compliant and the manufacturing plant @ Mumbai is USFDA approved & Indore is WHO – GMP approved. Independent USFDA complaint Analytical Lab. Enaltec has further development it’s R&D centers & Enaltec Pharma Research Pvt Ltd – Formulation R&D center operates in CRO Model with capabilities in Solid Orals, Liquid Orals, Injectable, Ointment

We are looking for competent candidates to take care of the various activities at our R&D center as below mentioned:

Department :- Regulatory Affairs – API
Job Location:- Pithampur (Indore)
Designation:- Assistant Manager / Manager
Preferred Qualification:- MSc/B Pharm/M Pharm
Required Experience :- 07+ Years in Regulatory Affairs – API

Skill Set :- Expertise in registration for APIS in the form of DMF, CEP, ASMF, MF as per ICH M4Q requirements in eCTD format in various Agencies like FDA, EU, EDQM, TGA, Canada, Anvisa, Russia, etc. Should be well familiar with requirements of Various Regulatory Authorities w r to API registrations, Compliance and Customer support.

Job Role
Assistant Manager / Manager
Preferred skills for this job
Creativity., Management.