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Associate Regulatory Affairs Specialist

Associate Regulatory Affairs Specialist

Radiant Systems IncRepublic Of India, IN
4 hours ago
Job description

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

Job Description :

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 codesusing 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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    Regulatory Specialist • Republic Of India, IN

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