Officer / Sr. Officer – Regulatory Affairs

3 - 5 Years

Job Description

Should have experience in compilation of DMFs for various regulatory authorities such as EDQM, USFDA in accordance to the filing requirements of Regulatory Authority as per ICH CTD.

Should have Working knowledge about preparation of Drug Master File as per eCTD (Software provided by Pharmaready, etc) format/NeeS format & submission using CESP and ESG Pathway.
Should have experience in preparation and periodic updating of USDMFs (Annual updates.)

Should have experience in addressing the responses to queries received from the various customers on Applicants Part of DMF.

Should have experience in Preparation and submission of Open part/ Technical packages as per customer requirement.

Perks and BenefitsĀ 

Best in Industry

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Legal, Regulatory, Intellectual Property

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager


Desired Candidate Profile

Please refer to the Job description above


UG:B.Pharma - Pharmacy, B.Sc - Any Specialization

PG:MS/M.Sc(Science) - Any Specialization, M.Pharma - Pharmacy

Doctorate:Doctorate Not Required

Company Profile


We (formerly Zandu Chemicals Ltd.) are one of the fastest growing Pharmaceutical companies in India that combines the power of Science & Technology together. Established in 1991, we are headquartered in Mumbai and have a state-of-the-art US FDA successfully inspected facility with a capacity of 214 KL along with strong research & development capabilities strategically located in the industrial park of Ankleshwar, Gujarat.

We are a 100% EOU (Export Oriented Unit) engaged in manufacturing and exports of advanced drug intermediates and Active Pharma Ingredients (APIs). We are a specialized Pharma company focusing on the niche therapeutic areas of CNS, ARVs and Controlled substances having tremendous future growth potential. By virtue of this niche focus we have registered an impressive growth over the years.

Our strategy going forward is to further consolidate our pre-eminent position in the high growth therapeutic areas by expanding our capacity for present advanced intermediates and moving up the value chain by expanding capacity for APIs and diversifying product portfolio into the other high growth therapeutic areas.

We are a US FDA, EDQM, KFDA, WHO-GMP and Japanese MOH accredited company having certifications of ISO 9001, ISO 14001 and OHSAS 18001. We enjoy the CRISIL rating of A(-) and have SAP system in place.

While over 90% of our revenue is from established markets, we are growing rapidly in the emerging markets. We have an established track record in pharma business with focus on low to medium volume and high value products.

Customer-Centric Approach
We have spent years creating a culture around the customer and their needs.

Our customer-centric approach has won the status of a preferred supplier/strategic partner from global pharmaceutical innovators and generic companies. We have aligned the entire organization to be decisive and agile that keeps us winning our customers? appreciation.

Our commitment is to keep up our tradition of delivering customer value and having our valuable customers in the very heart of our corporate focus.
Business Focus
Our current business focuses on three major business segments:
Active Pharmaceuticals Ingredients (APIs)
Advanced Intermediates
Contract Manufacturing of APIs and Intermediates (with or without technology transfers)

Active Pharmaceutical Ingredients (APIs):
We focus on niche therapeutic areas of CNS, ARVs and Controlled substances. We specialize in CNS segments like ADHD, Anti-psychotics, Anti-vertigo, Anti-inflammatory, Pain management, Alzheimer disease and others. We are moving up the value chain by adding the capacities for APIs and other high growth therapeutic areas like Anti-diabetic, Anti-coagulants and others.

Advanced Intermediates:
We specialize in the production of advanced intermediates for the narcotic APIs such as Methyl Phenidate, Dexmethylphenidate, Fentanil, Sufentanil, Alfentanil, Methadone and other controlled substances, Piperazine derivatives and others. Our intermediates under scale-up and new development will include therapeutic areas like Anti-diabetic, Anti-coagulants, Anti-asthmatic, Anti-parkinson, Alzheimer disease and others.

Contract Manufacturing of APIs and Intermediates (with or without technology transfers):
We are supporting innovators and global generic pharma companies in their increasing need for stringent quality, regulatory compliant and complex chemistry handling facilities. We have many on-going contract manufacturing projects that involve complex chemistry and technological excellence. With the expertise and experience of our technical team we have a proven track record of timely deliverance of the projects.
View Contact Details+

Recruiter Name:KD Rohit / Viral Choksi



Reference Id:Regulatory Affairs - 01


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