Regulatory Affairs Specialist

5 hours ago

Mumbai, India Cube Hub Inc. Full time

Job Title: Associate Regulatory Affairs Specialist Job Duration: Assignment to last through 2026 Job Location: Location: Mumbai, Maharashtra, India, Location: Phoenix Market City, Kurla (West), Mumbai, Maharashtra, India Work Arrangement: Hybrid – On-site 1–2 days/week for training and collaboration; remainder remote We are seeking a detail-oriented and collaborative R egulatory Affairs Analyst to support global regulatory processes and compliance initiatives. This role will contribute to the automation and maintenance of regulatory documentation within a RIMS workflow solution, ensuring data integrity and timely reporting across multiple geographic regions. The ideal candidate will be based in Mumbai and work closely with cross-functional teams, with flexibility to support global operations across time zones. Key Responsibilities Manage the global Registration, Notification, and Certification ( RNC ) process, including data entry, maintenance, and reporting in ETQ and other systems. Generate and analyze SAP reports to ensure regulatory compliance; identify new stop codes using Excel functions like VLOOKUP . Maintain and update master databases in Excel and Power BI; support monthly reporting and follow-ups with GRA teams. Validate and monitor data in EQT systems for accuracy and compliance. Collaborate with global teams to ensure timely regulatory submissions and documentation. Support audits and maintain documentation aligned with regulatory standards. Drive continuous improvement initiatives for data integrity and reporting processes. Provide functional expertise in regulatory documentation and RIMS workflows . Assist in maintaining standardized system approaches aligned with industry best practices. Basic Qualifications Bachelor’s degree in Sciences, Engineering, Regulatory Affairs, Pharmaceutical Sciences, Life Sciences, or a related discipline. 1–3 years of experience in a regulated industry (e.g., medical device, pharmaceutical, cosmetic). Proven ability to communicate effectively in written and spoken English. Preferred Qualifications 3+ years supporting a regulatory or compliance organization. Experience in Regulatory Affairs or related field, particularly within a compliance function. Hands-on experience with ETQ, RIMS, and document management systems. Familiarity with Indian regulatory guidelines and global compliance standards. Advanced proficiency in Microsoft Excel (VLOOKUP, Pivot Tables ) and exposure to Power BI. Experience with SAP ERP systems and EQT or similar quality tracking tools. Strong analytical, organizational, and leadership skills. Demonstrated ability to work independently, manage multiple priorities, and meet deadlines. Collaborative, responsive, and innovative problem solver with a global mindset. Ability to work effectively in virtual teams across cultures and time zones. Additional Skills Ability to influence and engage across organizational levels. Strong attention to detail and ability to retain confidential information. Experience working in quality systems aligned with global regulations for Medical Devices, Consumer Products, and Cosmetics. Technical aptitude to assess needs, identify issues, recommend solutions, and lead change initiatives.

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