ISSHAAN HEALTHCARE PRIVATE LIMITED
Website:
isshaan.com
Job details:
Location: NOIDA
Department: Regulatory Affairs
Reports To: Director / CEO / Managing Director
About the Role
We are looking for a highly experienced and result-driven Head – International DRA who is an absolute expert in dossier preparation, compilation, review, and global submissions. The ideal candidate must be a master in building high-quality dossiers from scratch and leading product registrations across multiple international markets.
This role is critical for expanding our business globally through fast, accurate, and compliant approvals.
Key Responsibilities1. Dossier Leadership
- Lead complete preparation, compilation, review, and submission of dossiers for international markets.
- Develop CTD / ACTD / eCTD / country-specific dossiers with high accuracy.
- Ensure all modules are complete, compliant, and submission-ready.
- Handle dossier gap analysis and readiness assessment.
- Review technical documents, formulas, stability data, specifications, COA, validations, artwork, and supporting files.
- Convert raw internal data into professional regulatory dossiers.
- Build strong document systems, templates, and dossier libraries.
2. Global Product Registrations
- Manage registrations, renewals, variations, and post-approval changes across target markets.
- Coordinate with regulatory consultants, agents, and health authorities globally.
- Drive faster approvals with strong follow-up and strategic submission planning.
- Handle deficiency responses, queries, commitments, and authority communications.
3. Regulatory Strategy
- Define market-wise registration roadmap based on business priorities.
- Evaluate country requirements, timelines, risks, and documentation needs.
- Identify fastest and highest-value approval opportunities.
- Build regulatory launch plans for new markets.
4. Cross Functional Leadership
- Work closely with R&D, QA, QC, Production, Purchase, Packaging, Export, and Business Development teams.
- Ensure all internal departments provide accurate documents on time.
- Lead and mentor the regulatory team.
- Create trackers, KPIs, SOPs, dashboards, and approval pipelines.
5. Compliance & Excellence
- Maintain global regulatory compliance standards.
- Keep updated with changing international guidelines.
- Reduce dossier errors, rejections, and approval delays.
- Build a world-class regulatory function.
Required Skills & ExpertiseMust-Have
- Deep expertise in dossier preparation and dossier strategy.
- Strong hands-on experience with CTD / ACTD / eCTD formats.
- Proven success in international product registrations.
- Ability to create dossiers independently from raw data.
- Strong understanding of pharmaceutical documentation.
- Excellent knowledge of stability, specifications, validations, GMP, COA, artworks, labeling, and technical files.
- Strong communication and authority-handling skills.
- Leadership and team management ability.
- Excellent planning, ownership, and execution mindset.
Preferred Markets Experience
CIS, Africa, LATAM, Middle East, ASEAN, South Asia, Eurasia.
Qualifications
- B.Pharm / M.Pharm / PharmD / Life Sciences or equivalent.
- 10+ years experience in International Regulatory Affairs.
- Strong dossier submission track record.
Success Metrics
- Number of successful registrations
- Faster approval timelines
- Strong dossier quality score
- Low rejection / deficiency rate
- Renewal compliance
- New market launches
- Team productivity
Click on Apply to know more.