Senior Regulatory Submissions Manager
4 weeks ago
Senior Regulatory Submissions Manager Please only apply if you are an immediate joiner Location: Hybrid working from our office locations in Mumbai/Navi Mumbai/Hyderabad We are seeking two Senior Regulatory Submissions Managers to play a pivotal role in shaping how regulatory submissions are managed within our new Veeva RIMS platform. This is a high-impact opportunity to influence process design, system configuration, and regulatory compliance across a global organization. Duties will include: Define Submission Management Processes - Lead the design and documentation of end-to-end Regulatory Submission Management workflows - Partner across RA, QA, Clinical, and IT to identify process gaps and drive operational excellence Translate Business Needs into Veeva Configuration - Convert business requirements into Veeva RIMS configuration specifications - Collaborate with IT and Veeva consultants to ensure the system supports planning, tracking, publishing, and archival of submissions Ensure Compliance & Best Practice Alignment - Align processes with Health Authority expectations and industry standards - Maintain robust documentation of decisions, processes, and configurations Serve as SME & Project Contributor - Act as Subject Matter Expert in workshops, design sessions, testing cycles, and UAT - Help guide change management and end-user adoption Person Specification: - Experienced in Regulatory Affairs and Submissions Management - Hands-on familiarity with Veeva RIMS (or comparable regulatory systems) - Strong communicator, collaborator, and process-thinker - Comfortable influencing cross-functional teams in a global environment Why join G&L? This role offers the opportunity to work at the forefront of global drug development while embedded with a top-tier pharmaceutical client. You will gain exposure to high-impact projects, contribute to advancing innovative therapies, and play a strategic role in shaping regulatory pathways worldwide - all while being supported by our expert, global teams of consultants. If you're passionate about regulatory excellence and digital transformation in life sciences, we'd love to hear from you.
-
Regulatory Global Submission Manager
2 weeks ago
Bengaluru, India GSK Full timeJob Description Site Name: Bengaluru Luxor North Tower, Mississauga Milverton Drive, Poznan Grunwaldzka Posted Date: Nov 19 2025 Job Title: Regulatory Global Submission Manager Key Responsibilities - In close collaboration with Regulatory Asset Oversight, GRL and RMT, provides project management support at submission level, drives execution of agreed plans...
-
Senior Specialist, Submission Management
24 hours ago
Hyderabad, India Bristol Myers Squibb Full timeJob Description Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that...
-
Manager, RA Publishing
2 weeks ago
Bengaluru, India Astellas Pharma Full timeJob Description Purpose And Scope Summarize the primary purpose of the position in 1-3 sentences. Intent is to capture the work this position does and is accountable for and why the role exists as a unique position. Not intended to be a summary of all duties. Responsibilities include managing the planning, preparation, submission and tracking of...
-
Regulatory Affairs Manager
3 weeks ago
Hyderabad, India Amgen Full timeJob Description The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the...
-
India Ixoreal Biomed Full timeShri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts. Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal Extracts,...
-
ICSR Submission Specialist
19 hours ago
Mumbai, Maharashtra, India, Maharashtra Alkem Laboratories Ltd. Full timeAbout AlkemAlkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the top five pharmaceutical companies in India. Our portfolio includes...
-
Manager - Regulatory
4 days ago
India Vodafone Idea Limited Full time ₹ 6,00,000 - ₹ 18,00,000 per yearRoleTM – RegulatoryJob Level/ Designation M1/ ManagerFunction / DepartmentTechnology/QualityLocationGuwahatiHiring ManagerIndranil ChaulyaJob PurposeTo ensure 100% regulatory (SACFA/WPC/EMF/MRO/TRAI) compliance of all exiting radio network and new radio network/Technology upgradation getting rolled out with timelinesKey Result Areas/Accountabilities100%...
-
Submission Specialist
24 hours ago
Hyderabad, India Bristol Myers Squibb Full timeJob Description Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that...
-
Manager, Regulatory Operations
3 days ago
Bengaluru, India Syner-G Full timeJob Description Company Description A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range...
-
Regulatory Affairs Manager
19 hours ago
Bengaluru, Karnataka, India, Karnataka Biocon Biologics Full timeKey Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation...