Executive/ Senior Executive- Regulatory Affairs _ EU markets
Job Description
Role Objective: To lead and manage the compilation, submission, and lifecycle maintenance of high-quality regulatory registration dossiers (eCTD format) for the European market (including DCP, National, and MHRA procedures). The role ensures absolute compliance with EU regulations, timely response to health authority queries , and seamless execution of post-approval variations and change controls
KEY RESPONSIBILITIES
Dossier Compilation & Submission: Compile and submit high-quality registration dossiers in eCTD format in strict accordance with current EU & ICH guidelines for DCP, National procedures, and MHRA submissions.
Query Management: Thoroughly assess and draft technically sound, timely responses to queries raised by European regulatory agencies within agreed-upon timelines.
Lifecycle Management & Variations: Manage the post-approval lifecycle of products, compiling variation packages and executing changes in licenses via variations and notifications.
Portal & Tool Management: End-to-end handling of electronic submissions via the EU/MHRA Portal using eCTD software tools.
Technical Documentation Review: Coordinate, collate, and perform high-quality reviews of standard technical documents including specifications, stability data, Product Development Reports (PDR), method validations, sterility assurance packages, BMR, and BPR to ensure ICH/EU alignment.
Compliance Maintenance: Review and handle change control proposals, assessing their regulatory impact and implementation strategy. Maintain a basic working knowledge of European Medical Device Regulations and Pharmacovigilance requirements.
STAKEHOLDER INTERACTION
Type of Interaction: Internal
Interaction with: Cross-functional teams including R&D, Quality Assurance (QA), Quality Control (QC), Production/Manufacturing, and Corporate Regulatory teams.
Nature of Interaction: Coordinating and collating technical documentation (BMR, BPR, stability studies, validation reports) ; reviewing change control proposals and aligning on execution timelines.
Type of Interaction: External
Interaction with: European Regulatory Agencies (Health Authorities across the European continent, including MHRA, and reference member states for DCP/National procedures).
Nature of Interaction: Dossier submissions , addressing regulatory queries/clarifications , and managing portal communications
JOB REQUIREMENTS
Professional Experience and Relevant Skills
Experience: 4 to 8 years of core experience in Regulatory Affairs, with a strong and preferred background in the European Regulatory Domain.
Technical Expertise:
Deep understanding of EU Regulations, EU Procedural Guidance, and ICH Guidelines.
Proficiency in eCTD software and handling EU/MHRA submission portals.
Solid understanding of Variation guidance, lifecycle management, and change control processes.
Foundational knowledge of EU Medical Device Regulations and Pharmacovigilance.
Skills: Excellent written and verbal communication skills ; strong drafting/writing abilities for regulatory responses ; highly organized, self-initiated, optimistic, and a collaborative team player.
Academic Qualifications & Certifications
Educational Qualification: M.Pharm only & Post graduate diploma in Regulatory Affairs
Behavioural Competency (Proficiency Levels from 1 – 5, with 1 being the lowest and 5 being the highest)
Achievement Orientation (3)
Problem Solving and Decision Making (3)
Integrity and Process Compliance (4)
Effective Communication (3)
Customer Orientation (2)
Team Management (1)
Collaboration (3)
Strategic Orientation (2)
Planning and Execution (3)