Role Summary

Lead end-to-end EU Regulatory Affairs activities with full ownership of pre-submission strategy, right-first-time high-quality dossiers, and lifecycle management across EU/UK markets. The role will drive efficient execution of all submission procedures (DCP, MRP, RUP, National), ensure proactive deficiency management, and lead cross-functional alignment to enable timely approvals and product launches.

The position also requires team leadership, regulatory oversight, and stakeholder engagement with agencies and partners.

Key Responsibilities

Regulatory Strategy & Pre-Submission Excellence

- Define and execute regulatory strategies for EU/UK submissions, ensuring alignment with business and market timelines
- Drive right-first-time, high-quality dossier development (Modules 1–5) with strong focus on completeness and compliance
- Lead pre-submission readiness, including gap assessments, risk identification, and mitigation plans

EU Submissions

- Manage end-to-end submissions for:

o DCP, MRP, RUP and National procedures
- Ensure compliance with EMA, MHRA, ICH, and regional regulatory requirements

Deficiency & Query Management
- Lead efficient handling of validation queries and deficiency letters
- Drive cross-functional coordination (CMC, QA, QC, R&D;, partners) for timely and quality responses
- Ensure risk-based, scientifically robust justifications aligned with agency expectations

Documentation & Compliance

- Author/review Module 1–5 content, including:

o SmPC, PIL, labeling (QRD compliant)
- Ensure eCTD readiness, publishing accuracy, and submission compliance




- Maintain adherence to global regulatory standards and cGMP requirements

Stakeholder & Agency Management

- Serve as primary interface with EU regulatory authorities and partners
- Support customer interactions, due diligence, and licensing activities
- Drive alignment with internal and external stakeholders for submission success

Leadership & Team Management

- Lead and mentor a team of regulatory professionals
- Establish explicit deliverables, timelines, and accountability
- Build capability in EU regulatory strategy, dossier quality, and execution excellence

Required Skills & Expertise

- Strong hands-on experience in EU regulatory procedures (DCP, MRP, National, RUP)
- Proven expertise in eCTD dossier preparation, review, and submissions
- Demonstrated experience in deficiency management and agency interactions
- Strong understanding of EMA, MHRA, ICH guidelines and expectations
- Excellent technical writing, review, and regulatory risk assessment skills

Qualifications

- M.Pharm / B.Pharm (or equivalent)
- 12+ years of Regulatory Affairs experience, with strong EU exposure

Key Competencies

- Strategic thinking with execution excellence
- Strong ownership and accountability mindset
- Effective cross-functional collaboration and stakeholder management
- Ability to manage multiple complex submissions under tight timelines
- Proven team leadership and capability building

Success Indicators

- High rate of right-first-time dossier acceptance
- Timely approvals with minimal deficiencies
- Strong regulatory compliance and inspection readiness
- Effective team performance and delivery consistency

📌 Senior Manager - EU ( Regulatory Affairs) (Hyderabad)
🏢 Granules India
📍 Hyderabad