Professional Associate Regulatory Affairs Specialist

Job Description: Max Bill Rate $11.95/hr. USD
Assignment to last through 2026
Location: Art Guild House 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 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
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.
Additional Sills:

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