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Monday 6 June 2016

Drug Regulatory Affairs Executive

1 - 4 YearsDelhi/NCR(National Capital Region)Openings: 4


Job Description

Preparation, Review and submission of Technical documents/Dossiers (CTD/eCTD) related to Regulatory affairs for third country Export of Pharmaceuticals Formulations. Preparation and Review of SOPs. Compilation of Validation Protocols/Reports. Preparation, Review, Submission of Technical and other Documents/Dossiers with Drug Controller General of India/CDSCO/State FDAs for-Registration for import of pharmaceuticals Formulations and bulk drugs. -Import Licenses-Export Licenses-Manufacturing & Marketing licenses -WHO-GMP Certification-No Objection Certificates etc. Liasioning with DCGI/CDSCO/state FDA offices/Directorate General of Foreign Trade /FICCI/PHD Chamber of Commerce etc.

Company Profile

United Biotech (P) Limited is a global research driven pharmaceutical company established in 1997. Since inception we have only one focus - "Care for Patients". We endeavour to become a respected research driven, global pharmaceutical company aimed at providing economical & quality medicines for a healthier tomorrow.United Biotech is a leading Pharmaceutical Company founded by a group of pharma professionals in 1997. The focus of all our activities is to provide best medicines to help patients smile once again. At the heart of United Biotech's operations are its core values - Integrity, Excellence & Commitment. For more than 17 years of experience in healthcare industry, United Biotech has discovered, developed, manufactured and marketed high quality innovative medicines. Since its establishment, we are committed to research, develop & market pharma products across all major therapeutic areas such as Cancer, Cardiovascular Disorders, Renal Disorders, Tuberculosis and Hormone Disorders. United Biotech is one of the most admired companies with its focus on 'Treating illness and sustain day-to-day wellbeing'. United Biotech embodies a very Human spirit by always remaining at the forefront to introduce innovative drugs for treating illness and to address unmet patient needs. The innovativeness, competitiveness and a will to succeed against all odds are the qualities that are at the heart of United Biotech's culture. All this Synergies with the dream of our founder, who has spent his lifetime in the pursuit of his mission of providing world class specialty healthcare products at affordable costs. After ascertaining its credentials in the domestic market, United Biotech starts spreading its wings beyond India with aim to establish a worldwide presence. United Biotech with thrust on becoming the leader, the company presence in international pharma market grown strikingly over the years. We have a global presence in over 55 countries through productive alliances and partnership and increasingly through our in-house sales effort in international market. We expect to continue to expand our presence in all over the world.

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