Manager / Sr Manager Regulatory Affairs- US Markets

2 weeks ago

Nashik, India Umedica Laboratories Private Limited Full time

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries. We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement. As part of our further expansion and growth plans, we are looking to hire Manager / Sr Manager Regulatory Affairs- US Markets in Regulatory Affairs department. This position is based at our R&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs. The remuneration package will be commensurate with the incumbent's professional experience and will be in line with market standards. Key Responsibilities: - Regulatory Submissions: - Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA - Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports) - Ensure compliance with current USFDA regulations and guidance documents - FDA Interactions: - Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings) - Participate in and support FDA meetings as the regulatory lead - Handle Controlled Correspondence with the FDA for product development and regulatory strategy - Product Expertise: - Provide regulatory support for complex formulations, including injectables and liquid dosage forms - Collaborate with R&D, QA, QC, and manufacturing teams to ensure regulatory alignment throughout the product lifecycle - Leadership & Communication: - Lead a team of regulatory professionals, providing guidance, training, and performance management - Communicate effectively with internal stakeholders and external regulatory bodies Qualifications & Experience: - Master's degree in Pharmacy - 13-15 years of experience in US Regulatory Affairs with a proven track record in ANDA/NDA submissions - Hands-on experience with FDA meetings, Controlled Correspondence, and post-approval changes - Strong understanding of injectables, liquid dosage forms, and complex generics - Excellent written and verbal communication skills - Demonstrated leadership and team management capabilities

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