Regulatory Affairs Manager Molkem Chemicals

8.0 - 12.0 years

10 - 13 Lacs

Ahmedabad

Work from Office

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables. Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements. Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions. Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed. Participate in internal and external audits and inspections related to regulatory compliance. Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation Qualifications Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred. Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry. Skills Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.

Posted 1 day ago

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Process Head KAVS SPECTRONOVA TECHNOLOGIES PRIVATE LIMITED

8.0 - 12.0 years

0 Lacs

thane, maharashtra

On-site

As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will be responsible for leading the process engineering aspects of pharmaceutical plant projects. Your role will involve overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. Your key responsibilities will include leading the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. You will be required to develop and review essential documents including P&ID, Process Flow Diagrams, Mass Balances, Equipment Sizing, and Critical Design Parameters. Additionally, you will prepare and evaluate User Requirement Specifications (URS) and oversee various tests and validation protocols such as FAT, SAT, DQ, IQ, OQ, and PQ to ensure compliance with regulatory standards like GMP, WHO, USFDA, and EU. Collaboration with cross-functional teams such as R&D, Quality Assurance, HVAC, Utility, Electrical, Instrumentation, and Automation will be a crucial part of your role. Your technical expertise and leadership will be essential during project execution, commissioning, and regulatory audits. Client meetings, technical presentations, and troubleshooting activities will also be a part of your regular responsibilities, along with international travel for projects, site visits, audits, and technical review meetings. To qualify for this position, you should hold a Bachelor's or Master's degree in Chemical Engineering or Pharmaceutical Engineering with 8 to 12 years of experience in process design and execution of pharmaceutical plant projects. A deep understanding of regulatory requirements including GMP, WHO, USFDA, and EU is essential. Demonstrated leadership skills in managing diverse teams and external consultants/vendors, excellent communication, documentation, and presentation abilities, as well as the capability to handle multiple projects under strict timelines are required. A valid passport is mandatory for this role, and prior international exposure is highly desirable. In return, we offer you a challenging leadership role in global pharmaceutical projects, opportunities for international exposure and career advancement, a collaborative work environment that emphasizes innovation and compliance, as well as competitive compensation and benefits in line with industry standards. To apply for this position, please send your updated resume to suchita@spectronova.com with the subject line: Application for Process Head Pharma Projects.,

Posted 3 days ago

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