Hire Arjun

Arjun Verma

Arjun Verma is a Regulatory Affairs Specialist with 9 years of experience in global regulatory compliance, submissions, and post-approval lifecycle management within the pharmaceutical industry. he excels in managing variation and renewal submissions, coordinating with cross-functional teams, and ensuring timely delivery of high-quality regulatory documentation. Skilled in CTD/eCTD preparation, CCDS review, and RIMS data integrity, demonstrates a proactive approach to problem-solving and strategic planning. Recognized for precision, accountability, and innovation, he was honored as Innovation Champion – Q2 2024 for her contributions to process optimization and regulatory excellence.

FORMERLY AT

Freyr Solutions

LOCATION

Banglore

AVAILABILITY

Full Time

Skills

CTD

Data Integrity Tools

eCTD

MS Office

MS Office Suite

Quality Management Systems (QMS)

Regulatory Publishing Tools

Regulatory Submission Platforms

RIMS

TrackWise

Work Experience

Growth and Emerging Market Regulatory Lead (GEMRL)

Freyr Solutions

April 2023 – Present

Lead preparation and coordination of post-marketing and post-approval submissions including variations, renewals, and MAH transfers.
Prepare Module 1 documents and manage submission timelines with global and local regulatory teams.
Support CCDS reviews, variation and PSUR submissions, and ensure RIMS data integrity.
Maintain submission deliverable plans and communicate regulatory risks to internal stakeholders.
Perform QC of published sequences and contribute to continuous process improvement

TECHNOLOGIES

CTD, eCTD, RIMS, Regulatory Publishing Tools, MS Office Suite

QA Reviewer – Quality Assurance

Exela Pharm Sciences Ltd. (Remote)

August 2019 – March 2023

Reviewed Annual Product Review Summaries (APRS) and managed deviation investigations and reports.
Maintained change request trackers and ensured timely follow-up on open actions.
Supported nitrosamine risk assessments and collaborated with QA teams to strengthen compliance frameworks.

TECHNOLOGIES

TrackWise, Quality Management Systems (QMS), MS Office, Data Integrity Tools

Executive – Regulatory Affairs

Hetero Labs Ltd.

September 2017 – July 2019

Prepared variation packages for EU markets, reviewed regulatory documents, and responded to deficiency letters from health authorities.
Supported change control documentation, eCTD preparation, and ensured compliance with submission standards.

TECHNOLOGIES

CTD, eCTD, Regulatory Submission Platforms, MS Office