Regulatory Affairs_ Associate _ M1
Full Time
Gurgaon
Posted 1 day ago
Profile: Associate – Regulatory Affairs (M1)
Location: Gurgaon, Haryana, India (Onsite)
Role Overview:
We are hiring a detail-driven Associate – Regulatory Affairs (Module 1) to support global submission activities and ensure compliance with evolving regulatory requirements. The role involves compiling, reviewing, and managing Module 1 dossiers while coordinating with cross-functional teams to meet critical submission timelines. The ideal candidate brings strong knowledge of regional regulatory frameworks, high attention to detail, and the ability to manage documentation with precision
Job Descriptions:
- Prepare, review, and compile Module 1 of regulatory submissions in accordance with regional requirements.
- Maintain up-to-date knowledge of global regulatory guidelines and ensure company compliance.
- Coordinate with cross-functional teams including clinical, quality, and manufacturing to gather necessary documentation.
- Assist in the preparation and maintenance of regulatory dossiers and submission tracking.
- Support interaction with health authorities and respond to regulatory queries promptly and accurately.
- Contribute to the development and implementation of regulatory strategies to facilitate product approvals.
- Ensure documentation accuracy, completeness, and adherence to company and regulatory standards.
Education & Experience:
- Bachelor’s / master’s degree in pharmacy / Life Sciences
- Regulatory Affairs certification (optional but preferred)
Knowledge, Skills and Abilities:
- Excellent written and verbal communication skills with a strong attention to detail.
- Proficiency in regulatory submission software and MS Office applications.
- Good problem-solving and coordination skills
- Ability to work in a fast-paced, deadline-driven environment
Behavioural Competencies:
- Detail-oriented with high focus on quality and compliance
- Strong team player with collaborative mindset
- Ability to handle pressure and manage multiple submissions simultaneously.
Why to Join us:
- Growth Opportunities
- Learning Exposure
- Better Compensation