POSITION OVERVIEW

The Assistant Manager, Regulatory Affairs will contribute to end-to-end regulatory activities, from planning and preparation through submission and post-submission follow-up. The role will also work closely with global regulatory teams, providing support on tasks such as preparation and compilation of regulatory submission packages, as and when required.

PRIMARY RESPONSIBILITIES

- All DCGI submission through SUGAM portal (Clinical trial application, Import license application, Site additions, SAE / DSUR / Status report, Protocol amendments, CSR etc)
- Collating and customizing all the documents for dossier preparation for DCGI
- Preparing cover letters for all the regulatory submissions
- CTRI registration
- Manage end-to-end regulatory tasks assigned, ensuring timely and quality delivery
- Prepare, review, and compile regulatory submission packages (e.g., new applications, variations/amendments, renewals, annual reports)
- Support global regulatory teams with submission-related activities, including document formatting, publishing, QC checks, and dossier assembly
- Coordinate with cross-functional teams (Quality, Manufacturing, Clinical, Labelling, Supply Chain) to gather required documents and data • Track and respond to queries or deficiency letters from health authorities
- Maintain accurate regulatory records, trackers, and databases
- Ensure compliance with applicable regulations, guidelines, and internal SOPs •





Monitor regulatory changes and flag potential impact to the team
- Support audits and inspections by providing regulatory documentation
- Contribute to process improvements and team knowledge sharing

QUALIFICATIONS AND SKILLS:
- Education: Bachelors or Master’s degree in Pharmacy, Life Sciences, or a related field preferably with Clinical research course

. • Experience: Up to 5 years of relevant working in Clinical Research industry having experience handling Global Clinical trials, in a regulatory position.
- Skills:

Working knowledge of regulatory submission processes and dossier formats (preferably SUGAM and additionally with CTD/eCTD)

Understanding of regulatory guidelines (specially CDSCO, ICH, and preferably with FDA, EMA, depending on business scope)

Familiarity with regulatory publishing or document management tools (a plus)

Strong attention to detail and documentation skills

Good written and verbal communication skills

Ability to work with global teams across time zones

Strong organisational and time-management skills

Ability to manage multiple tasks and meet deadlines

Proactive, cooperative, and adaptable approach

- Preferred (Good to Have)

Experience supporting global or multi-region submissions

Exposure to regulatory information management systems (RIMS)

Prior experience handling health authority queries

📌 Assistant manager - Regulatory Affairs (Delhi)
🏢 WOW Softech
📍 Delhi