About Company:
Cadila Pharmaceuticals is Founded by Shri I.A. Modi, Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India, headquartered at Ahmedabad, in the State of Gujarat. Over the last seven decades, the company has been developing and manufacturing pharmaceutical products in India and selling and distributing these in over hundred other countries around the world. Focused strongly on Innovation and Research, the company is present in more than forty-five therapeutic areas spread across twelve specialities, including cardiovascular, gastrointestinal, analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics and immunologicals. At Cadila Pharmaceuticals, Research and Development is at the core of all its initiatives, be it Biotechnology, APIs, Formulations, Plant Tissue Culture or Phytochemistry. More than 300 scientists in its various Research and Development setups reinforce the competitiveness of research in the therapeutic areas which have high unmet medical needs. Cadila Pharmaceuticals Excellence in manufacturing facilities is central to Cadila Pharmaceuticals. The company’s formulations manufacturing plant at Dholka near Ahmedabad, Gujarat is spread over hundred acres of land. This state-of-the- art facility is not only impressive in size, but is also USFDA approved. The second formulations manufacturing facility is located at Samba in Jammu and Kashmir. The facility meets most of the stringent quality standards across the globe to produce tablets, capsules, soft and hard gelatin capsules, liquids and orals. Two Active Pharmaceutical Ingredient (API) manufacturing units at Ankleshwar, Gujarat manufacture a wide range of APIs and intermediates including many USFDA-certified products. The company has strong foothold in the African continent through its formulation manufacturing facility at Addis Ababa in Ethiopia. For more information visit: https://www.cadilapharma.com/
Website
https://www.cadilapharma.com/
Vacancy Details:
Job Role: Regulatory Affairs (US Market)
Job Location: Dholka, Ahmedabad, Gujarat
Experience require: Minimum 6 Years
Key Deliverables of the Role:
1.Compilation, review and submission of registration dossiers in the regions of US.
2.Handling of regulatory queries/deficiencies.
3.Post approval activities: Review of Annual Reports, post-approval supplements (CBE-0, CBE-30, PAS) submission.
4.eCTD software handling for ANDA/IND submission, query response and post approval submission.
5.Review and approval of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols/ process validation protocols/Process validation reports Batch manufacturing records, Batch Packaging records, Formula clearance etc.
6.Review of Analytical method validation / verification / transfer reports.
7.Review of DMF and its notifications.
8.Review and approval of Change Controls & Deviations.
9.Creation and Maintenance of Regulatory Database for all the submissions.
10Tracking of Regulatory Guidance Documents at the respective websites.
12.Imparting training across the team on new guidance documents.
Interested Candidate can share your CV on
Email: disha.bhalani@cadilapharma.com