Assistant Manager - Drug Regulatory Affairs (eu - Team Lead Role)
- Nadsoft
- 5 - 10 years
- Mumbai
- 19 hours ago
- Email to a friend
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Job Description
Sr. Officer / Executive DRA (FRD Background)
Department: Drug Regulatory Affairs (DRA)
Experience: 57 Years (Mandatory FRD Background)
Role Overview:
This role is designed for professionals transitioning from Formulation R&D into Regulatory Affairs. The incumbent will leverage formulation development knowledge to support dossier preparation, regulatory submissions, and lifecycle management activities for global markets.
Key Responsibilities:
Regulatory Documentation & Submission:
- Prepare, review, and compile regulatory dossiers in CTD/eCTD format for submission to global regulatory authorities.
- Author and review key modules (Module 2 & 3) with strong alignment to formulation development data.
- Support ANDA, EU dossiers, and other regulatory filings.
FRD Integration:
- Utilize hands-on FRD experience to interpret formulation data, stability studies, and development reports.
- Coordinate with FRD teams to obtain accurate and compliant technical data for submissions.
Lifecycle Management:
- Handle post-approval variations, amendments, and query responses from regulatory agencies.
- Ensure timely submission of variations and compliance updates.
Compliance & Coordination:
- Ensure adherence to regulatory guidelines (USFDA, EU, WHO).
- Work closely with cross-functional teams including FRD, QA, QC, and manufacturing.
Candidate Profile:
- M.Pharm / B.Pharm with strong FRD exposure (OSD preferred).
- 57 years of experience with transition into DRA activities.
- Good understanding of CTD structure and regulatory documentation.
- Strong analytical, documentation, and coordination skills.
Officer / Sr. Officer DRA (EU / US Market)
Department: Drug Regulatory Affairs (DRA)
Experience: 36 Years
Role Overview:
The role focuses on supporting regulatory submissions and lifecycle management for regulated markets such as the US and Europe. The candidate will be responsible for dossier compilation, submission tracking, and regulatory compliance.
Key Responsibilities:
Dossier Preparation & Submission:
- Compile, review, and submit dossiers in CTD/eCTD format for USFDA and EU markets.
- Prepare Module 1, 2, and 3 documents in coordination with internal teams.
Regulatory Lifecycle Management:
- Handle post-approval changes, variations, renewals, and deficiency responses.
- Track submission timelines and ensure regulatory commitments are met.
Regulatory Intelligence:
- Stay updated with changing regulatory requirements and guidelines for US/EU markets.
- Support impact assessment of new regulations on existing products.
Cross-Functional Coordination:
- Liaise with FRD, Analytical R&D, QA, and manufacturing for data collection and compliance.
- Ensure accuracy and completeness of submission documents.
Candidate Profile:
- M.Pharm / B.Pharm.
- 36 years of hands-on experience in DRA for USFDA / EU markets.
- Good knowledge of CTD/eCTD submissions and regulatory guidelines.
- Strong documentation and communication skills.
Assistant Manager DRA (EU Team Lead Role)
Department: Drug Regulatory Affairs (DRA)
Experience: 10+ Years
Role Overview:
This is a leadership role responsible for managing EU regulatory activities, leading dossier submissions, and overseeing a team. The incumbent will ensure regulatory compliance, timely approvals, and strategic alignment with business objectives across European markets.
Key Responsibilities:
Regulatory Strategy & Leadership:
- Lead EU regulatory strategy for product registrations and lifecycle management.
- Manage and mentor a team of regulatory professionals.
- Act as the primary point of contact for EU regulatory matters.
EU Regulatory Expertise:
- Demonstrate deep understanding of European regulatory frameworks, directives, and guidelines.
- Handle submissions via Centralised Procedure (CP), Decentralised Procedure (DCP), and Mutual Recognition Procedure (MRP).
- Ensure compliance with EMA and country-specific requirements.
Dossier Compilation & Review:
- Oversee end-to-end preparation, review, and submission of CTD/eCTD dossiers across all modules.
- Ensure high-quality, compliant, and audit-ready submissions.
Technical Writing & Review:
- Lead drafting, editing, and reviewing of regulatory documents to ensure clarity, consistency, and compliance.
- Review complex technical documents including Module 2 summaries and Module 3 data.
Project & Stakeholder Management:
- Manage multiple submission projects with defined timelines and deliverables.
- Coordinate with cross-functional teams (FRD, QA, QC, Manufacturing, RA Global teams).
- Drive efficient execution of regulatory plans and mitigate risks.
Regulatory Tools & Systems:
- Ensure effective use of regulatory submission tools (eCTD software, publishing tools).
- Maintain submission databases and tracking systems.
Candidate Profile:
- M.Pharm / B.Pharm with 10+ years in Regulatory Affairs (EU focus).
- Strong experience in handling EU submissions and team management.
- Expertise in CTD/eCTD, EMA procedures (CP, DCP, MRP).
- Excellent leadership, project management, and communication skills.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Legal & Regulatory - OtherRole: Legal & Regulatory - OtherEmployement Type: Full timeContact Details:
Company: NALocation(s): Mumbai
Keyskills: Europe Ectd MHRA Regulatory Affairs Dossier Drug Regulatory Affairs Dossier Preparation Regulatory ENT RA CTD Formulation Regulatory Compliance
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