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Job opportunity for Regulatory Writing Lead at Indegene-Apply before 30th June 2025

Indegene
Pharmacareer

Website Indegene

Location: Bangalore, India
Application Deadline: 30th June 2025

About Indegene

We support biopharmaceutical, emerging biotech, and medical device companies across the product development life cycle — from concept to market. Through a blend of healthcare domain expertise, modern technology, and agile operations, we deliver tailored solutions that improve outcomes and experiences for both patients and physicians. We’re driven by a shared mission to make healthcare organizations future-ready.

Position Overview

We are seeking a Lead – Regulatory Writing professional to spearhead regulatory strategy and operations across global markets. This role will oversee submission planning, life-cycle management, and regulatory compliance, ensuring alignment with international standards and timely health authority engagement.

Key Responsibilities

  • Lead the preparation, review, and submission of regulatory dossiers for MA applications across global regions including US, EU, LATAM, APAC, GCC, and CIS.

  • Manage post-approval regulatory activities including license renewals, variations, and label updates.

  • Liaise with local affiliates and health authorities to align on strategic submission timelines and requirements.

  • Oversee regulatory impact assessments related to change controls and quality system updates.

  • Develop and implement regulatory SOPs and maintain regulatory tools and databases (e.g., Veeva RIMS, TrackWise).

  • Lead regulatory meetings with clients and stakeholders to align on strategy and timelines.

  • Guide and mentor a high-performing regulatory team, ensuring delivery of key operational metrics.

Candidate Profile

  • Educational Qualification: BPharm, MPharm, Pharm D, or MSc in a life science discipline.

  • Experience: 8–10 years in Regulatory Affairs, preferably in a global regulatory setting.

  • Deep understanding of international regulatory procedures (e.g., EU CP, MRP, DCP, National routes).

  • Hands-on experience in submissions and life-cycle management.

  • Familiarity with regulatory software tools (e.g., Veeva RIMS, TrackWise).

  • Strong leadership, communication, and project management skills.

  • Proficient in Microsoft Office and Adobe Professional.

Why Join Us?

  • Work with a forward-thinking team that values innovation and collaboration.

  • Be part of projects that impact global patient outcomes.

  • Opportunities for growth in an agile and future-focused organization.

How to Apply:
Submit your resume to [email or application link] by 30th June 2025.
Please mention “Lead – Regulatory Writing” in the subject line.

To apply for this job please visit careers.indegene.com.