Regulatory Affairs Specialist

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.