Regulatory Affairs Consultant
Based in IndiaFull-TimeSenior
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- 8–11 years
- Required Skills
- ComplianceStakeholder management
Requirements
- 8–11 years of experience in Regulatory Affairs within pharmaceutical, biotech, or life sciences organizations.
- Strong knowledge of EU and US regulatory requirements, submission processes, and post-approval obligations.
- Hands-on experience in global submission management and regulatory lifecycle activities.
- Solid understanding of regulatory documentation standards and compliance frameworks.
- Experience handling Health Authority interactions and regulatory correspondence.
- Strong organizational, coordination, and stakeholder management skills.
- Ability to manage multiple complex deliverables in a global, fast-paced environment.
- Educational background in B.Sc., M.Sc., B.Pharmacy, or M.Pharmacy.
- Excellent communication skills with attention to detail and a quality-driven mindset.
Responsibilities
- Support global regulatory lifecycle management activities across EU, US, and other international markets.
- Contribute to the development of regulatory strategies for global and regional product submissions.
- Prepare, coordinate, and manage regulatory submission dossiers (Modules 1–5) ensuring accuracy and compliance.
- Manage post-approval activities including variations, amendments, and lifecycle maintenance submissions.
- Handle communications with Health Authorities, including responses to queries and clarification requests.
- Provide submission planning and coordination support, including timeline tracking and deliverable management.
- Maintain regulatory data and documentation within Regulatory Information Management (RIM) systems.
- Support safety-related regulatory deliverables such as aggregate reports and urgent safety updates.
- Assist in audit preparation, inspections, and compliance-related activities across regulatory functions.
View Full Description & ApplyYou'll be redirected to the employer's site
