Sourcing and Procurement of Pharmaceutical Raw Materials viz. API, Excipients, Packaging Materials at Cost Competitive Prices. Bachelors degree with more than 10 years of experience in Pharmaceutical Purchase.
Prepare submission check-list based on regulatory & product specific requirements Dossier compilation and review of ANDA’s for different dosage forms. Review of all technical documents which are required for ANDA compilation (Specifications, STP, COA’s, protocols, BMR’s, BPR’s, Bio related documents etc....) Review of documents (Master BMR’s, Master BPR’s, specifications, protocols, EIR report, IIG etc...) received from other cross functional teams for the products under development. Preparation and review of controlled correspondences for different dosage forms as per the R&D request. Compilation of sections required for query responses received from Agency. Communicating with the cross functional teams and CMO’s for requesting the documents required for ANDA compilation. Compilation of post approval submissions (CBE-30, PAS) if applicable Checking for the current version of documents for submitting it to Row market as per requirement Preparation of checklists (to review the BMR, BPR, ANDA document request, ANDA checklist for internal references). Checking for USFDA current updates and new Guidance’s published in website. Training to fresher in the department with all Regulatory Affairs aspects. Reviews document change controls. Support the maintenance of regulatory files and databases, ensuring accuracy and completeness of documentation. Following with USFDA and EMA sites for current updates. Any other related duties as assigned by Team Leader B.Pharmacy/M.pharmacy with experience of 4 to 8 years in Formulation Regulatory Affairs.
Assist in the execution of formulation and process technology transfers from R&D to manufacturing sites (in-house and CMO). Conduct scale-up and exhibit batches under supervision, ensuring proper documentation and parameter tracking. Support in the preparation and review of Batch Manufacturing Records (BMRs) and validation protocols/reports . Coordinate with R&D, QA, QC, Regulatory Affairs, and Manufacturing teams for effective knowledge transfer and execution. Participate in process investigations, troubleshooting, and deviation handling during trial and validation batches. Assist in equipment selection and capacity assessment based on product-specific requirements. Ensure document readiness for regulatory submissions , respond to technical queries, and support audit preparation. Support internal and external/vendor audits by providing required documentation and technical inputs. Contribute to continuous improvement initiatives and support knowledge-sharing activities within the MSTG team. Prepare data summaries, technical reports, and presentations as per project or management requirements. Maintain accurate records , follow applicable SOPs , and ensure strict GMP compliance in all operations. Qualifications & Skills B.Pharm / M.Pharm in Pharmaceutics or Pharmaceutical Technology. 2–5 years of experience in formulation development, MS&T, or technology transfer. Exposure to solid orals, liquids, or softgel capsule dosage forms. Understanding of scale-up principles , equipment functionality , and validation practices . Familiar with regulatory expectations (USFDA, EU, etc.) and cGMP standards. Good communication, documentation, and teamwork skills. Willingness to travel to manufacturing sites as per project requirements.
1. To lead and manage the entire Formulation & Development activities including both Formulation development. 2. Responsible for proposing new projects, designing, execute development activities, timely completion of robust formulations and processes development followed by technology transfers. 3. Responsible for designing novel strategies, developing new platform technologies for all dosage form. 4. Responsible for development of variety of formulation products (Generics, Modified and NDDS) with QbD concepts as per timelines for regulated markets and anticipated markets as per company requirements. 5. Expertise in risk analysis and designing mitigation plans proactively leading to success in resolution. 6. Responsible for improving the good development practices with systematic development approach. 7. Establish short- and long-term project goals and design strategies to achieve. 8. Mentoring and training juniors for skill development with high moral values. 9. Drive culture of self-development in the team. 10. Work proactively with other cross-functional teams in Indonesia and Head Office in Korea to resolve the project related issues and lead to successful completion in timelines. 11. Authoring and finalizing project related technical reports and other scientific reports. 12. Interaction with API manufacturers, CRLs, CMOs and Academic Institutions as needed Minimum qualification : Master of Pharmacy
Job Summary: The Director, Regulatory Affairs – India Operations will lead the India-based regulatory function, with primary responsibility for managing and executing high-quality regulatory submissions for the U.S. market, with a focus on complex sterile generic products including peptides, microspheres, and drug-device combinations. This role is central to ensuring timely ANDA submissions, comprehensive and effective responses to complex FDA deficiencies, and seamless coordination with global stakeholders and strategic partners. The position requires deep expertise in U.S. regulatory requirements, strong leadership skills to manage and grow a high-performing team, and the ability to operate in a dynamic, cross-functional, and international environment. Key Responsibilities: 1. Regulatory Strategy & Execution: o Lead the planning, preparation, and submission of high-quality ANDAs for the U.S. FDA, focusing on sterile and complex dosage forms. o Ensure submission strategy and dossier content align with FDA expectations and current regulatory standards. o Drive timely, accurate, and strategic responses to complex deficiency letters, including scientific justifications, bridging strategies, and risk-based assessments. 2. Complex Dosage Expertise: o Serve as the regulatory subject matter expert for complex dosage forms including peptides, microspheres, injectable suspensions, and drug-device combination products. o Anticipate regulatory challenges and proactively mitigate potential issues during development and review phases. 3. Team Leadership & Talent Development: o Lead and mentor a growing team of 15+ Regulatory Affairs professionals, fostering a culture of accountability, innovation, and continuous improvement. o Implement effective training, knowledge sharing, and performance development programs to strengthen technical and regulatory capabilities within the team. 4. Cross-Functional & Partner Collaboration: o Collaborate closely with R&D, QA, CMC, CMO, Project Management, and global Regulatory Affairs teams to drive regulatory activities and timelines. o Serve as the key regulatory contact for external development and commercial partners, ensuring alignment and responsiveness in joint submissions and communications. 5. Regulatory Intelligence & Compliance: o Monitor and interpret U.S. FDA regulatory developments and trends; ensure dissemination of critical updates to internal stakeholders. o Maintain high standards of regulatory compliance and documentation integrity throughout the submission lifecycle. 6. Planning & Communication: o Develop and manage regulatory project plans, submission timelines, and team deliverables, ensuring visibility and alignment with global leadership. o Provide regular status updates, risk assessments, and strategic insights to senior management on ongoing submissions and regulatory priorities. Qualifications & Experience: Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline. 15+ years of experience in Regulatory Affairs within the generic pharmaceutical industry, with deep expertise in U.S. FDA ANDA submissions. Demonstrated success in handling complex products and preparing strategic responses to FDA deficiency letters. Strong knowledge of eCTD submissions, FDA regulatory pathways, and current GDUFA environment. Proven experience managing and growing regulatory teams of 15+ professionals. Effective communicator with ability to influence across functional lines and international stakeholders. Experience working with external development, CMO, and licensing partners is essential. Preferred Skills: Exposure to global regulatory filings (EU or RoW) is an advantage but not required. Familiarity with regulatory publishing tools and document tracking systems. Ability to thrive in a matrixed, deadline-driven, and fast-paced work environment. Qualifications & Experience: Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline. 15+ years of experience in Regulatory Affairs within the generic pharmaceutical industry, with deep expertise in U.S. FDA ANDA submissions. Demonstrated success in handling complex products and preparing strategic responses to FDA deficiency letters. Strong knowledge of eCTD submissions, FDA regulatory pathways, and current GDUFA environment. Proven experience managing and growing regulatory teams of 15+ professionals. Effective communicator with ability to influence across functional lines and international stakeholders. Experience working with external development, CMO, and licensing partners is essential.