Cadila Healthcare Limited Zydus Cadila is a fully integrated, global healthcare provider, with strengths all along the pharmaceutical value chain. With a core competence in the field of healthcare, Zydus Cadila provides total healthcare solutions ranging from formulations, active pharmaceutical ingredients and animal healthcare products to wellness products. From a turnover of Rs. 250 crores in 1995, the group posted revenues of over Rs. 8600 crores in FY15. The group had posted a turnover of Rs. 4600 crores in FY 11, making it a billion dollar company. Recently, the group launched Exemptia, the world’s first biosimilar for Adalimumab, the largest selling therapy worldwide for inflammatory arthritis. Zydus is also the only Indian pharma company to launch its own patented NCE – Lipaglyn, the world’s first drug to be approved for the treatment of diabetic dyslipidemia. The Zydus group was one amongst the top five companies worldwide at the FT ArcelorMittal Boldness in Business Awards 2014 in the Developing Markets category and was declared as the ‘Emerging Company of the Year’ by the Economic Times Awards for Corporate Excellence 2010. The group aims to be a leading global healthcare provider with a robust product pipeline and aspires to post revenues of
Rs. 10000 crore by 2015-16 and be a research-based pharmaceutical company by 2020Job Title – Assistant Mgr / Manager- Regulatory Affairs (US Market)
Experience – 3 – 7 Years
Location – Ahmedabad
Job Description:
1. Co-ordination with various sites (viz. development site, manufacturing site, contract testing sites and DMF holder) for collection and review of documents related to ANDA, deficiencies and post approval supplements.
2. Review of ANDAs, deficiencies, and post approval supplements for Solid Oral/Pulmonary/ topical dosage forms
3. Preparation of controlled correspondences for Q1-Q2, IIG etc.
4. Co-ordination with the development site during the development phase of the new products. Assist, understand and contribute towards development of the product from regulatory perspective.
5. Preparation of action points for the deficiencies received from the Agency and assessment of the Agencys expectations. Preparation of the responses based on the data received from various departments.
6. Proactive review of documents and data generation for ensuring quick response to queries received from the Agency and customers to expedite the approval process.
7. Review of label artwork, SPL and package inserts.
8. Keeping abreast of guidelines.
9. Deficiency Response
Desired Profile:
UG – B.Pharma – Pharmacy
PG – M.Pharma – Pharmacy
