About Company:
Adaptis Pharma is a regulatory solutions and services company that offers end-to-end global regulatory and pharmacovigilance services to pharmaceutical and life sciences industries. The services include customizable and professional ANDA parking, global regulatory and pharmacovigilance services to generic industries. Adaptis is established in August 2020 and headquartered at Panaji, Goa, and operational office at Pune, Maharashtra, India. Adaptis expertise in specialized regulatory strategy and fillings across all major global markets for all type of products and dosage forms. We serve emerging-to-enterprise organizations on a worldwide basis, by delivering cost effective regulatory solutions with quality. Our Mission is “To support our client’s business by providing high quality services and simplified solutions.” Our Vision is “To become most trusted business partner and service provider for health care companies.” Our Service Portfolio Detailed as fallows: • ANDA Holding • End-to-End Global Pharmacovigilance Services • Regulatory Intelligence • Regulatory Strategy and Business Consulting • End-to-End Regulatory Support for the Companies Looking for Expansion in to the Regulated and Semi-Regulated Markets • Complete Support for Compilation of USDMF/APIMF/WHO- PQP/ANDA/NDA/IND/BLA/MA Modules with no RTR Assurance for ANDA • Artwork and Labeling • Dossier Query Response Submissions • Post Approval Submissions like Prior Approval Supplement, Change Being • Effected Supplement and Variation Filing for Global Market • Lifecycle Management of DMF/ANDA/MA • Regulatory Software (eCTD and Structured Product Labeling) • R&D Regulatory Strategy and Systems • Controlled Correspondence with USFDA • Clinical and Non-Clinical Overview • US Agent Services • Audit and Compliance • Dossier Due Diligence For more information reach out us @E-mail: bd@adaptisls.com; info@adaptisls.com; Mobile: +91 9923419592 or +91 9834614269
Website
https://www.adaptisls.com
Vacancy Details:
𝐏𝐨𝐬𝐢𝐭𝐢𝐨𝐧: Formulation Regulatory Affairs Assistant Manager
𝐄𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞: 4-6 Years (USA Market, Original ANDA Section Writing)
𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧: Pune (Work from Office)
Qualification: M. Pharm/B. Pharm
Are you a skilled professional in Regulatory Affairs with experience in Formulation for the USA market? Join our dynamic team and make an impact in the pharmaceutical industry!
𝐖𝐡𝐚𝐭 𝐖𝐞’𝐫𝐞 𝐋𝐨𝐨𝐤𝐢𝐧𝐠 𝐅𝐨𝐫:
1.Expertise in ANDA/NDA preparation for Solid Orals/Injectables
2.Experience in writing M1, M2, M3, M5 sections
3.Proficiency in eCTD compilation and query responses
4.Strong analytical, communication, and presentation skills
5.M. Pharm/B. Pharm degree
𝐊𝐞𝐲 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐢𝐞𝐬:
1.Preparation & review of ANDA/NDA submissions
2.Bioequivalence, CMC, and labelling document review
3.Support Post-Approval Supplements
Email: info@adaptisls.com
