Lead and manage end-to-end regulatory activities predominantly for US ANDA submissions and post-approval lifecycle management for complex sterile dosage forms. Guide and supervise a team of 4–5 senior regulatory associates, providing strategic direction, mentoring, and performance oversight. Act as a regulatory lead in cross-functional teams (CFTs) involving R&D, QA, QC, AR&D, Formulation, and Project Management to resolve regulatory deficiencies and plan responses. Strategize and draft FDA deficiency responses, ensuring alignment with regulatory expectations and internal timelines. Liaise with R&D for preparing controlled correspondences, pre-submission meetings and teleconferences packages, as needed. Ensure timely and compliant filing of supplements (PAS, CBE-30, CBE-0), annual reports, and amendments. Monitor and interpret evolving FDA regulations and guidances; assess impact and implement regulatory strategy changes accordingly. Represent Regulatory Affairs in partner meetings and contribute to regulatory planning and communication with external stakeholders and business partners. Review and approve critical CMC documentation, bridging technical content with regulatory requirements. Drive continuous improvement in regulatory processes, systems, and team capabilities. 15+ years of experience in US Regulatory Affairs with a strong focus on sterile injectable products and complex generics. Proven experience with microsphere formulations, peptides, BFS, nasal sprays, ophthalmics, ointments, and other sterile/non-oral dosage forms. In-depth knowledge of US FDA regulations, eCTD submissions, and FDA communication pathways. Hands-on experience in handling FDA queries, CRLs, and working closely with CFTs to compile timely and high-quality responses. Strong leadership, project management, and cross-functional collaboration skills. Excellent communication, analytical, and problem-solving abilities.
Candidate shall be capable to handle Formulation development activities in lab & plant for sterile products like Injectables, Ophthalmics, lyo products, Inhalations etc.. M. Pharm with 2 to 4 years experience
Candidate shall be capable of handling Formulation development, documentation and Tech transfer of complex injectables like Microspheres & other injectables/Ophthalmic products. M.Pharm with 7+ years experience
Senior Research associate capable to handle projects of Injectable, ophthalmic, lyo products, Infusions with formulation development and support for tech transfer. M.Pharm (Pharmaceutics / Industrial Pharmacy) with 5+ years experience.
1) Analytical method validation 2) Analytical method transfer 3) Analytical method verification 4)Having instrument knowledge on HPLC, UPLC,GC Master of Science Master of pharmacy
Managing Project Management activities for both internal and client projects. Managing New Product Launch Activities for both internal and client projects. Work with clients, contract manufacturing sites and other partners for timely delivery of the projects. Implement project management tools and methodologies to track the project progress and identify potential risks. Communicate with all relevant departments to facilitate day-to-day operations and meet project deadlines. Establish Confidentiality Agreements and Quality Agreements with CMOs, Select external labs for project-specific needs and collaborate with them to ensure project completion. Ensure the availability of project pre-requisites at every stage of project launch to facilitate smooth execution. To ensure the seamless execution of validation and launch batches at Contract Manufacturing Organization (CMO) sites. Prepare regular Project status presentations for stakeholders, summarizing project progress, issues, and risks including meeting minutes. Support the clinical team in organizing essential documents and samples. MBA, MPharma is highly preferred. 2-4 years of experience in Regulated Generics Market, with preference for prior experience with New Product Launches or Commercial Operations.
The Stability Coordinator will be responsible for overseeing and coordinating stability testing activities for pharmaceutical development, ensuring timely execution of stability pull and testing schedules in collaboration with Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs). This role involves managing schedules, ensuring compliance with procedures, and acting as a liaison between internal teams and external partners. The ideal candidate will have strong organizational skills, experience in pharmaceutical stability programs, and a thorough understanding of regulatory requirements. Key Responsibilities: Coordination of Stability Testing Schedules: Develop and manage stability pull and testing schedules in collaboration with CMOs/CTOs to ensure timely execution of stability studies. Monitor adherence to schedules, proactively addressing any delays or issues to maintain compliance with project timelines. Ensure all stability testing activities are performed in accordance with approved protocols, procedures, and regulatory requirements. Liaison with CMOs/CTOs: Act as the primary point of contact for CMOs/CTOs regarding stability testing activities, fostering strong communication and collaboration. Coordinate the transfer of stability samples, protocols, and related documentation between internal teams and external partners. Review CMO/CTO stability testing plans to ensure alignment with company standards and regulatory expectations. Regulatory Compliance: Ensure all stability testing activities comply with applicable regulatory requirements, including FDA, EMA, ICH, and other global standards. Maintain up-to-date knowledge of regulatory guidelines related to stability testing and ensure their integration into testing schedules and procedures. Support regulatory submissions by providing stability-related documentation and data as required. Deviation Management: Investigate and resolve deviations related to stability testing at CMOs/CTOs, conducting root cause analyses and implementing corrective and preventive actions (CAPA). Monitor the effectiveness of CAPA implemented by CMOs/CTOs to ensure continuous compliance and quality improvement. Document and report deviations and resolutions to internal stakeholders and management. Data Management and Documentation: Oversee the collection, review, and documentation of stability data generated by CMOs/CTOs, ensuring accuracy, completeness, and compliance. Maintain robust data management practices, including proper storage, retrieval, and archiving of stability-related documentation. Support the implementation and maintenance of electronic systems (e.g., LIMS) for stability data management. Collaboration and Communication: Work closely with cross-functional teams, including Quality Control, Quality Assurance, Regulatory Affairs, and Manufacturing, to align stability testing with project goals. Communicate effectively with internal and external stakeholders, providing clear updates on stability testing progress and issues. Represent the stability function in meetings and discussions related to pharmaceutical development. Continuous Improvement: Identify opportunities to streamline stability testing processes and improve coordination with CMOs/CTOs. Participate in internal audits and contribute to the development and refinement of standard operating procedures (SOPs) for stability activities. Support quality improvement initiatives related to stability testing and data management. Training and Support: Provide training and guidance to internal teams and external partners on stability testing procedures and regulatory requirements. Support the professional development of team members involved in stability activities, fostering a culture of compliance and excellence. All other relevant duties as assigned Job Requirements Education: Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or a related field. Advanced degree or certification in Quality Control or Stability Testing is preferred. Experience: 3+ years of experience in pharmaceutical stability programs or quality control within the pharmaceutical or biotech industry. Proven experience coordinating with CMOs/CTOs for stability testing or related activities. Strong understanding of regulatory requirements for stability testing (e.g., FDA, EMA, ICH guidelines). Skills: Exceptional organizational and time-management skills with the ability to manage multiple schedules and priorities. Strong communication and interpersonal skills, with the ability to build effective relationships with internal and external stakeholders. Detail-oriented with a commitment to accuracy and regulatory compliance. Effective problem-solving skills, particularly in managing deviations and implementing CAPA. Preferred Qualifications: Experience with electronic data management systems (e.g., LIMS). Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Familiarity with stability study design and data analysis. Working Conditions: Office-based position with occasional travel to CMOs/CTOs, manufacturing sites, or external partners as required. Ability to work effectively across different time zones as needed.
The Stability Coordinator will be responsible for overseeing and coordinating stability testing activities for pharmaceutical development, ensuring timely execution of stability pull and testing schedules in collaboration with Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs). This role involves managing schedules, ensuring compliance with procedures, and acting as a liaison between internal teams and external partners. The ideal candidate will have strong organizational skills, experience in pharmaceutical stability programs, and a thorough understanding of regulatory requirements. Key Responsibilities: Coordination of Stability Testing Schedules: Develop and manage stability pull and testing schedules in collaboration with CMOs/CTOs to ensure timely execution of stability studies. Monitor adherence to schedules, proactively addressing any delays or issues to maintain compliance with project timelines. Ensure all stability testing activities are performed in accordance with approved protocols, procedures, and regulatory requirements. Liaison with CMOs/CTOs: Act as the primary point of contact for CMOs/CTOs regarding stability testing activities, fostering strong communication and collaboration. Coordinate the transfer of stability samples, protocols, and related documentation between internal teams and external partners. Review CMO/CTO stability testing plans to ensure alignment with company standards and regulatory expectations. Regulatory Compliance: Ensure all stability testing activities comply with applicable regulatory requirements, including FDA, EMA, ICH, and other global standards. Maintain up-to-date knowledge of regulatory guidelines related to stability testing and ensure their integration into testing schedules and procedures. Support regulatory submissions by providing stability-related documentation and data as required. Deviation Management: Investigate and resolve deviations related to stability testing at CMOs/CTOs, conducting root cause analyses and implementing corrective and preventive actions (CAPA). Monitor the effectiveness of CAPA implemented by CMOs/CTOs to ensure continuous compliance and quality improvement. Document and report deviations and resolutions to internal stakeholders and management. Data Management and Documentation: Oversee the collection, review, and documentation of stability data generated by CMOs/CTOs, ensuring accuracy, completeness, and compliance. Maintain robust data management practices, including proper storage, retrieval, and archiving of stability-related documentation. Support the implementation and maintenance of electronic systems (e.g., LIMS) for stability data management. Collaboration and Communication: Work closely with cross-functional teams, including Quality Control, Quality Assurance, Regulatory Affairs, and Manufacturing, to align stability testing with project goals. Communicate effectively with internal and external stakeholders, providing clear updates on stability testing progress and issues. Represent the stability function in meetings and discussions related to pharmaceutical development. Continuous Improvement: Identify opportunities to streamline stability testing processes and improve coordination with CMOs/CTOs. Participate in internal audits and contribute to the development and refinement of standard operating procedures (SOPs) for stability activities. Support quality improvement initiatives related to stability testing and data management. Training and Support: Provide training and guidance to internal teams and external partners on stability testing procedures and regulatory requirements. Support the professional development of team members involved in stability activities, fostering a culture of compliance and excellence. All other relevant duties as assigned Job Requirements Education: Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or a related field. Advanced degree or certification in Quality Control or Stability Testing is preferred. Experience: 3+ years of experience in pharmaceutical stability programs or quality control within the pharmaceutical or biotech industry. Proven experience coordinating with CMOs/CTOs for stability testing or related activities. Strong understanding of regulatory requirements for stability testing (e.g., FDA, EMA, ICH guidelines). Skills: Exceptional organizational and time-management skills with the ability to manage multiple schedules and priorities. Strong communication and interpersonal skills, with the ability to build effective relationships with internal and external stakeholders. Detail-oriented with a commitment to accuracy and regulatory compliance. Effective problem-solving skills, particularly in managing deviations and implementing CAPA. Preferred Qualifications: Experience with electronic data management systems (e.g., LIMS). Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Familiarity with stability study design and data analysis. Working Conditions: Office-based position with occasional travel to CMOs/CTOs, manufacturing sites, or external partners as required. Ability to work effectively across different time zones as needed.
Job Summary: Performs microbiological testing of raw materials, intermediate/finished products, and environmental bio-burden. Independence, leadership, and technical skills are required to maintain a functional, current and GMP compliant microbiology laboratory. Responsible for continually evaluating the laboratory systems to ensure quality and efficiency. Expected to effect policy with suggestions for improvements. Must be able to handle assignments independently and work with little or no supervision. Job Responsibilities Perform Microbial Limits and Microbial Limits Validation assay of finished products, raw materials, and components. Perform bio-burden monitoring of the manufacturing facility and the microbiology laboratory. Review the current USP and the regulatory guidance to ensure compliance with updates to microbiological methods. Maintain currency with microbiology practices and policies in the pharmaceutical industry. Oversee the and maintenance of the USP Purified Water System. Author and review microbiology protocols and reports. Author, review, and revise microbiology STP's and SOP's. Train backup analysts for microbiology tasks in his/her absence. Ensure coverage of microbiology assays with back-up analyst for weekend and holiday testing schedules. Evaluate trend analysis of microbiology results from tested products, water and bio-burden and author reports. Coordinate microbiology testing to complete deliverables in a timely manner. Perform IQ/OQPQ on instruments and author the protocols/reports. Attend seminars on special topics to continually evaluate improvements to the microbiology laboratory, testing , and policy. Act as the microbiology expert for audits and consultations, as required. General procurement assignments and responsibilities for the microbiology laboratory: monitor housekeeping, bio hazard waste disposal, sample discard, discard of expired reagents, media preparation, sterilization of waste and glassware, instrument calibration/maintenance/daily monitoring, quarterly expenses report, and inventory/ordering. Works as a member of a team to achieve all outcomes Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion All other relevant duties as assigned Job Requirements Education o Bachelor’s degree in microbiology (B.S.) o Master’s degree in microbiology (M.S.) Knowledge, Skills and Abilities o Ability to apply advances mathematical concepts such as exponents, logarithms, quadratic equations, linear regression, and permutations. o Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, and correlation techniques. o Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. o Ability to read, analyze, and interpret common scientific and technical journals, specifications, standard operating procedures, and standard testing procedures. Ability to write presentations and articles that conform to prescribed style and form. Ability to effectively present information to middle management. o o Proven strong organizational, time management, and project management skills. Demonstrated experience in coordinating project activities o Strong organizational, interpersonal and communication skills - excellent command of the English language, both written and verbal o Ability to be a self-starter, work independently and manage multiple priorities in a fast-paced and changing environment o Ability to challenge the status quo in an effort to drive systemic change and improvements o Working knowledge of GMP o Proficiency with Word, Excel, MS Access, SAP (preferred) and statistical software Experience o A minimum of 7-10 years of progressively related experience (Bachelor’s degree) o A minimum of 5-7 years of progressively related experience (Master’s degree)