Transglobal Odyssey Pvt. Ltd.
Website:
tgody.com
Job details:
We're Hiring: Senior Executive – Drug Regulatory Affairs (DRA)
📍 Location: Delhi
💼 Experience: 2–4 Years
🏢 Department: Regulatory Affairs
We are seeking a proactive, detail-oriented, and motivated Senior Executive – Drug Regulatory Affairs (DRA) to join our Regulatory Affairs team. The ideal candidate will have hands-on experience in dossier preparation, regulatory submissions, and lifecycle management of pharmaceutical products across regulated and semi-regulated markets.
Key Responsibilities
- Prepare, compile, review, and submit CTD/eCTD dossiers for product registrations.
- Manage regulatory submissions, including new registrations, variations, renewals, and responses to health authority queries.
- Prepare and review Module 1 administrative documents and other product registration dossiers.
- Coordinate with cross-functional teams, including R&D, Quality Assurance (QA), Quality Control (QC), Manufacturing, and Business Development, to obtain the required documentation for regulatory submissions.
- Review product labels, artworks, package inserts, and other regulatory compliance documents to ensure adherence to applicable guidelines.
- Maintain regulatory databases and monitor submission timelines to ensure timely filings.
- Stay updated with current regulatory requirements, ICH guidelines, GMP standards, and country-specific registration regulations.
- Support new product registrations, post-approval submissions, and lifecycle management activities.
Requirements
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline.
- 2–4 years of experience in Pharmaceutical Drug Regulatory Affairs.
- Strong knowledge of CTD/eCTD dossier preparation, regulatory documentation, and submission processes.
- Experience handling registrations in regulated and/or semi-regulated markets will be an added advantage.
- Good understanding of GMP, ICH guidelines, and international regulatory requirements.
- Excellent communication, documentation, organizational, and coordination skills.
- Proficiency in Microsoft Office applications.
What We Offer
- Opportunity to work on international regulatory projects.
- A collaborative and growth-oriented work environment.
- Continuous learning and career development opportunities.
Click on Apply to know more.