Head - Regulatory Affairs - Pharmaceutical/Oral Solid Injectable - US Market/ANDA

Head - Regulatory Affairs - USFDA/ANDA - Pharmaceutical/Oral Solid Injectable

We have excellent career opportunity as Head Regulatory Affairs (US Market/ANDA) with experience in Pharmaceutical industry of 15-20 yrs .Experience in team handling of more than 25 people.

Candidate must be on Top Management with Regulatory Experience for US Market/Filling.Experience in Oral Solid, Injectable,Formulation must.

Candidate will be responsible for Team of 40 people.

Post graduate in Pharmacy Minimum 10 years of experience in ANDA submission and should be currently active in the same field Should be able to assess the QMS documents and its impact on the regulatory filings, Well versed with the latest US REQUIREMENT and guidelines for oral solids and injectable products, Should have experience in handling a team of minimum 8 people, Should be good in communication and leadership quality, Should be able to communicate effectively within the group and with external customers, Should have a good skill of problem solving.

About Company :

We are fast growing Indian Pharmaceuticals Company engaged in developing, manufacturing and marketing a broad range of pharmaceuticals products in-house, which we commercialize through marketing infrastructure across geographies and relationships with multi-national pharmaceuticals companies.

We are ranked as the 14th largest pharmaceuticals Company in India in terms of market share based on the domestic sales of pharmaceuticals products. We believe that our competitive advantage in the domestic market lies in our established presence in all major therapeutics areas including blood related, cardiology, pain and analgesics, HIV, Gynecology, nephrology, anti-Vitamins, minerals, and nutrients products. We have also recently entered in oncology and diabetes therapeutics areas.