Associate Regulatory Affairs Specialist

Position: Associate Regulatory Affairs Specialist

Location: Mumbai, Maharashtra, India

Contract Position

Work Arrangement: Hybrid On-site 2-3 days/week for training and collaboration Later REMOTE

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We are seeking a detail-oriented and collaborative Regulatory 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

• Bachelors degree in Sciences, Engineering, Regulatory Affairs, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• 13 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.

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• 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