Associate Regulatory Affairs Specialist

20 hours ago

Mumbai, Maharashtra, India Akaasa Infotech Noida Full time ₹ 6,00,000 - ₹ 18,00,000 per year

Job Title: Associate Regulatory Affairs Specialist

Experience: 5+ Years

Location: Mumbai(Hybrid mode)

Job Type: 12 months contract

REQUIREMENTS:

  • 5+ years supporting a regulatory or compliance organization.
  • Experience in Regulatory Affairs or a 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.

SUMMARY:

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.
  • 2-3 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

  • 5+ years supporting a regulatory or compliance organization.
  • Experience in Regulatory Affairs or a 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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Vishal Kumar

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