Regulatory Affairs (Pharma) Expert

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

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 visionCreating a future worth living. For patients. Worldwide. Every work with purpose and compassion supported by a global team of over 125000 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 Cares products meet the highest standards of quality safety and regulatory compliance throughout the entire product lifecycle. 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 harmonization. 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 nonclinical 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 lifecycle activities
Review labeling advertising and promotional materials for regulatory compliance
Maintain relationships with health authorities and industry peers
Partner with Quality Clinical Nonclinical and Manufacturing to align regulatory documentation
Improve regulatory processes and support audits inspections and other regulatory projects

Your Profile:

Bachelors degree in Life Sciences Pharmacy Chemistry Biology or 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
810 years of global regulatory affairs experience in drug development and lifecycle management across 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 nonclinical 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:

There is a lot you can discover at Fresenius Medical Care regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.

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

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

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 nonclinical 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 lifecycle activities
Review labeling advertising and promotional materials for regulatory compliance
Maintain relationships with health authorities and industry peers
Partner with Quality Clinical Nonclinical and Manufacturing to align regulatory documentation
Improve regulatory processes and support audits inspections and other regulatory projects

Your Profile:

Bachelors degree in Life Sciences Pharmacy Chemistry Biology or 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
810 years of global regulatory affairs experience in drug development and lifecycle management across 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 nonclinical 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:

There is a lot you can discover at Fresenius Medical Care regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.

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