Regulatory Submission Senior Analyst – at Merck, Apply Now!
Join a global leader driving innovation in healthcare, life sciences, and electronics. We are looking for a Senior Analyst – Regulatory Submission Management to join our dynamic regulatory affairs team in Bangalore’s Electronic City. This is your chance to work on global submissions, manage regulatory systems, and be part of a diverse and inclusive culture that celebrates curiosity and innovation.
- Job Title: Senior Analyst – Regulatory Submission Management
- Location: Electronic City, Bangalore
About the Company:
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Job Description:
Regulatory Submission & Document Management Specialist responsible for handling regulatory submissions, quality checks, and document management processes in compliance with global health authority requirements. This role will involve working with eCTD
format submissions, Veeva Vault RIM (Breeze), and eRDMS, ensuring accuracy, timely completion, and proper archival of regulatory records. The ideal candidate will have expertise in regulatory operations, document management, and technical support for regulatory systems.Key Responsibilities:
- Responsible for creating the submissions in eCTD format and Quality checks of the dossier for submission to various Health Authorities (Publishing) and creation of Submission Content Plan (SCP) for the submissions to various customers.
- Uploading, archival and maintenance of CMC documents and submissions records in Veeva Vault RIM.
- Record creation and maintenance for site registrations in eRDMS (Breeze)
- End-to-end records creation for various regulatory activities in Veeva Vault RIM.
- Creation and submission of KPI reports on a Quarterly basis for on-time registrations.
Training of Veeva Vault for new users in global level and providing technical support to Subject Matter Experts. - Create Health Authority queries for Pharma and Food Materials in RIM and track to closure.
- Data Correctness check in eRDMS through reporting and user support
Qualifications:
- Education: Master’s degree or PhD in Pharma, Regulatory Affairs, or a related field.
- Experience: 3 – 6 years in regulatory affairs of registrations, publishing, renewals, QC, validations, and regulatory submission processes in eCTD format. Experience in data management, compliance reporting, and regulatory records maintenance.
Skills:
- Excellent communication and collaboration skills to work with cross-functional teams.
- Ability to provide training and technical support.
- Strong analytical and problem-solving skills for data verification and reporting.
We are an equal opportunity employer that values workforce diversity.
We want everyone to be able to bring their best self to work every day, which is why equality and inclusion are at the forefront of all our activities. We are dedicated to a non-discrimination policy in employment on any basis, including race, caste, creed, color, religion, sex, age, disability, marital status, sexual orientation, and gender identity.
What we offer:
We are curious minds from various backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow independently. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Keywords: Senior Analyst, Regulatory Submission Management, Bangalore, Full-time, Regulatory Affairs, eCTD format, Veeva Vault RIM, Document Management
