Expert_Regulatory Submission Management at Merck Specialities Pvt. Ltd.

Bangalore, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

27 Mar, 26

Salary

0.0

Posted On

27 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Submission Management, Submission Planning, eCTD, Veeva Vault RIM, Compliance Monitoring, Cross-Functional Collaboration, Submission Package Creation, Data Accuracy, Health Authority Interaction, Publishing, Process Optimization, Subject Matter Expertise, Template Enhancement, Problem Resolution, Workflow Optimization, Documentation

Industry

Chemical Manufacturing

Description

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. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your Role: The Senior Regulatory Submission Manager is responsible for overseeing the planning, compilation, publishing, and dispatch of regulatory submissions to Health Authorities throughout the product lifecycle. This role ensures compliance with regulatory standards and optimizes submission processes to facilitate timely approvals. Who You Are: Minimum Requirements Minimum 7-13 years in Regulatory Submission Management. Master’s Degree in Life Sciences, Medical, PharmD, or equivalent. Maximum Requirements Manage and execute submission planning and execution across the product lifecycle. Create and maintain submission packages and content plans. Ensure the accuracy and completeness of regulatory data in Veeva Vault RIM. Track Health Authority queries, document approvals, and registration details.Publish and validate eCTD outputs to ensure successful submission.Monitor compliance with submission standards and processes.Collaborate with international cross-functional teams to resolve issues and optimize workflows. Provide guidance and oversight for submission management and publishing. Serve as a subject matter expert on eCTD and Veeva Vault RIM.Enhance submission templates and processes to meet evolving Health Authority requirements. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Responsibilities

The Senior Regulatory Submission Manager oversees the planning, compilation, publishing, and dispatch of regulatory submissions to Health Authorities throughout the product lifecycle. This role ensures compliance with regulatory standards and optimizes submission processes to facilitate timely approvals.