Regulatory Affairs (Pharma) Expert

Lifelancer; Bengaluru; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

A leading pharmaceutical company located in Bengaluru is seeking a Regulatory Affairs (Pharma) Expert. This role focuses on managing global regulatory strategies and submissions, ensuring compliance across various jurisdictions. The ideal candidate will have a Bachelor’s degree in Life Sciences or related fields, with 8-10 years of experience in regulatory affairs, particularly in eCTD submissions. This full-time role offers opportunities for professional development and being part of a mission-driven team committed to improving patient outcomes.

Qualifications

• 8-10 years of global regulatory affairs experience in drug development.
• Strong hands-on experience with global eCTD submissions.
• Deep knowledge of ICH guidelines and regional regulations.

Responsibilities

• Lead global regulatory strategy and submissions across regions.
• Plan and review eCTD submissions for regulatory compliance.
• Maintain relationships with health authorities and industry peers.

Skills

Global regulatory strategy

eCTD submissions

Regulatory compliance

Project management

Communication skills

Education

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology or related field

Advanced degree (M.S., Ph.D., Pharm.D.)

Tools

Veeva Vault RIM

RIMSmart

Job description

Job Title: Regulatory Affairs (Pharma) Expert

Job Location: Bengaluru, Karnataka, India

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 125,000 employees.

Within our Care Enablement segment we develop and provide life‑sustaining medical products, digital health solutions and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency and sustainable growth.

Our values guide how we work:

• We Care for our patients, each other and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation

Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety and regulatory compliance throughout the entire product life‑cycle. The team supports market access, innovation and patient safety by driving excellence across manufacturing and supply chain, overseeing post‑market surveillance and promoting continuous improvement and system harmonisation. SQR also manages regulatory and quality data governance and provides critical product‑related business services across global operations. Join our passionate team and help shape healthcare worldwide!

Your Responsibilities:

• Lead global regulatory strategy and submissions across U.S., EU, Canada, LATAM and APAC
• Plan, author and review eCTD submissions (IND, NDA, ANDA, MAA, variations, renewals, supplements)
• Represent Regulatory Affairs on cross‑functional teams, providing guidance on regional requirements and development pathways
• Provide strategic input on CMC, clinical and non‑clinical documentation for global compliance
• Coordinate electronic submissions with Regulatory Operations using Veeva Vault RIM, RIMSmart and global gateways (FDA ESG, CESP, BfArM, Health Canada, ANVISA)
• Monitor global regulations and communicate key changes to stakeholders
• Prepare regulatory correspondence, briefing packages and materials for health authority meetings
• Manage post‑approval commitments, renewals and life‑cycle activities
• Review labeling, advertising and promotional materials for regulatory compliance
• Maintain relationships with health authorities and industry peers
• Partner with Quality, Clinical, Non‑clinical and Manufacturing to align regulatory documentation
• Improve regulatory processes and support audits, inspections and other regulatory projects

Your Profile:

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology or a related field required; advanced degree (M.S., Ph.D., Pharm.D.) preferred
• RAC certification or equivalent highly desirable; ongoing professional development in global regulatory strategy is a plus
• 8–10 years of global regulatory affairs experience in drug development and life‑cycle management across the U.S., EU, Canada, LATAM and APAC
• Strong hands‑on experience with global eCTD submissions (IND, NDA, ANDA, MAA, variations, renewals, supplements)
• Proven success in global registration strategy and interactions with FDA, EMA, Health Canada, ANVISA, NMPA and other authorities
• Deep knowledge of ICH guidelines, regional regulations and global submission standards
• Proficiency with regulatory information/publishing systems (e.g., Veeva Vault RIM, RIMSmart) and electronic gateways
• Broad understanding of CMC, clinical and non‑clinical regulatory requirements
• Strong project management, communication and collaboration skills, with the ability to work independently in a global matrix, handle multiple complex projects and adapt to evolving regulatory requirements

Our Offer for you:

• Whether in front of or behind the scenes you are helping to make ever better medicine available to more and more people around the world
• Individual opportunities for self‑determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking—to find the best solution together, not the quickest one
• A large number of committed people with a wide range of skills, talents and experience
• The benefits of a successful global corporation with the collegial culture of a medium‑sized company