1. ANDA Compilation for Injectable Products.
2. Preparation of Annual Report & Submission to USFDA
3. Post Approval Activities
4. Supplemental Filing
5.Analytical and Reviewing skills.
6.Good presentation skills.
Note- Candidate having experience in Injectable working on US Market should only apply.
Salary: INR 3,25,000 - 8,00,000 P.A.
/ Clinical Research
Functional Area: Medical
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Employment Type: Permanent Job, Full Time
Desired Candidate Profile
Education:UG -B.Pharma - Pharmacy
PG - MS/M.Sc(Science) - Any Specialization, M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
Emcure Pharmaceuticals Limited
Emcure Pharmaceuticals Ltd. is a fast growing fully integrated Indian pharmaceutical company with global presence engaged in developing, manufacturing and marketing a broad range of pharmaceutical products globally. Our core strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which we commercialize through our marketing infrastructure across geographies and relationships with multi-national pharmaceutical companies.
Emcure is ranked 12th largest pharmaceutical company (Source: AIOCD Jan MAT 2017) in India in terms of market share based on the domestic sales of pharmaceutical products. Emcure believes that their competitive advantage in the domestic market lies in their established presence in all major therapeutic areas including blood related, cardiology, pain and analgesics, HIV, gynaecology, nephrology, anti-infective, and vitamins, minerals and nutrients products. We have also recently entered the oncology, diabetes & neuroscience therapeutic areas.
Emcure has a well-diversified income base thanks to our business in the international markets. Emcure products are currently shipped to over 65 countries. It has subsidiaries in Dubai, Brazil, South Africa, Singapore, Australia, Turkey, Peru and Nigeria and rep offices in Russia, Myanmar, Vietnam, Ghana, Kazakhstan and Morocco and established offices in US, UK and Canada. Emcure is working towards vast expansion in European Markets as well.
Emcure's focus our research and development efforts on developing a portfolio of differentiated products across several platforms, including chiral molecules and biosimilars, and novel drug delivery systems. They have a portfolio of 10 + chiral molecules, eight of which we launched for the first time in India. We also have capabilities to develop complex products, including difficult iron preparations, oncology drugs and controlled release products. Our portfolio of in-house manufactured five commercialized biosimilars including TNK-tPA, which we launched for the first time in India, and our brand Vintor is ranked no. 1 in erythropoietin market. As per the IMS Health India, TSA for March 2016, Emcure is ranked 1st in Gynaecologicals, 1st in Blood related, 2nd in Oncology, 2nd in HIV, 6th in Hepatoprotectives, 10th in Cardiac, 11th in Anti-malarials and 15th in Anti-infectives therapy areas.