Regulatory Affairs Consultant
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Consultant based in India.
This Regulatory Affairs Consultant role is a senior-level consulting position focused on supporting global regulatory lifecycle management across major international markets, including the EU and US.
You will play a key role in ensuring compliant, timely, and high-quality regulatory submissions that support the development and approval of therapies impacting patient outcomes worldwide.
The role involves working across end-to-end regulatory activities, from strategy development to submission execution and post-approval maintenance.
You will collaborate closely with global cross-functional teams to prepare, coordinate, and manage regulatory documentation and authority interactions.
A strong emphasis is placed on quality, compliance, and operational excellence across complex regulatory environments.
You will also contribute to audit readiness, safety reporting, and continuous improvement of regulatory processes.
This is a high-impact role suited for experienced professionals who thrive in global, detail-oriented, and compliance-driven environments.
Accountabilities:
- 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.
- 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.
- Competitive compensation aligned with senior regulatory consulting expertise.
- Opportunity to contribute to global drug development and patient-impacting therapies.
- Exposure to international regulatory environments including EU and US markets.
- Collaborative, mission-driven work environment focused on healthcare innovation.
- Strong career development opportunities within regulatory and consulting domains.
- Involvement in high-visibility projects across the full regulatory lifecycle.
- Continuous learning and exposure to evolving global regulatory frameworks.