Assistant manager - Regulatory Affairs

WOW Softech; Delhi; Hybrid; INR 800,000 - 1,400,000; Full time

Job summary

WOW Softech in Delhi, India invites an Assistant Manager, Regulatory Affairs to lead end-to-end regulatory activities, from planning through submission and post-submission follow-up. You will collaborate with global regulatory teams and prepare regulatory submission packages using SUGAM, CTD/eCTD formats.

You will coordinate with Quality, Manufacturing, Clinical, Labelling and Supply Chain to assemble dossiers, respond to health authority queries, and ensure compliance with CDSCO, ICH guidelines

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
• Up to 5 years of regulatory experience in Clinical Research or pharma.
• Knowledge of regulatory submission processes and dossier formats (SUGAM, CTD/eCTD).
• Familiarity with CDSCO, ICH guidelines; FDA/EMA exposure is a plus.
• Excellent written and verbal communication; strong cross-functional coordination.

Responsibilities

• Handle DCGI submissions through SUGAM portal (clinical trials, import licenses, site additions, etc).
• Collate and customize documents for regulatory dossiers.
• Prepare cover letters for submissions.
• CTRI registration; manage end-to-end regulatory tasks with timely delivery.
• Prepare, review, and compile regulatory submission packages.
• Support global regulatory teams with submission-related activities (formatting, QC, dossier assembly).
• Coordinate with Quality, Manufacturing, Clinical, Labelling, Supply Chain to gather documents/data.
• Track and respond to health authority queries or deficiency letters.
• Maintain 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 with regulatory documentation.
• Contribute to process improvements and team knowledge sharing.

Skills

Regulatory submissions

Cross-functional collaboration

Regulatory documents

Attention to detail

Time management

Global team coordination

Education

Bachelors/Master’s in Pharmacy or Life Sciences

Tools

SUGAM portal

CTD/eCTD formats

Job description

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, collaborative, 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