Website:
ivueverse.com
Job details:
Regulatory Associate / Consultant
Role Overview
We are looking for a Regulatory Associate/Consultant to support global regulatory projects across pharmaceuticals, biologics, and medical devices. The role involves regulatory strategy support, dossier preparation, submission management, lifecycle activities, and coordination with cross-functional stakeholders across global markets.
Key Responsibilities
- Support regulatory projects across US, EU, ASEAN, LATAM, India, and other global markets
- Assist in regulatory strategy development and market entry pathways
- Prepare, review, and compile regulatory dossiers (CTD, ACTD, eCTD, STED, DMF components)
- Manage end-to-end submission activities including formatting, documentation, and quality checks
- Support lifecycle management activities such as variations, renewals, and regulatory updates
- Draft and review responses to regulatory authority queries and deficiency letters
- Coordinate with internal teams to ensure timely and compliant project execution
- Track project timelines, deliverables, and submission documentation
- Ensure high-quality, compliant regulatory deliverables
Candidate Profile
Education
- B.Pharm / M.Pharm / PharmD / Biotechnology / Life Sciences
- Regulatory Affairs certifications are an added advantage
Experience
- 3–8 years of experience in Regulatory Affairs, Regulatory Operations, or Dossier Preparation
- Experience in Pharma, Biologics, or Medical Devices preferred
Required Skills
- Strong understanding of global regulatory frameworks (FDA, EMA, CDSCO, ASEAN, etc.)
- Hands-on experience in regulatory submissions and lifecycle management
- Expertise in CTD/eCTD/STED dossier preparation
- Strong analytical, documentation, and problem-solving skills
- Detail-oriented with strong quality and compliance focus
- Ability to manage multiple projects independently
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