Senior Regulatory Submissions Manager
5 days 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.
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Hyderabad, India G&L Scientific Full timeSenior 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...
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Regulatory Affairs Senior Manager
2 weeks ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 15,00,000 - ₹ 25,00,000 per yearThe RA CMC Senior 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 Senior Manager is responsible for communicating the...
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Senior Regulatory Affairs Specialist
4 days ago
Hyderabad, Telangana, India Dyaz Innovate Full time ₹ 8,00,000 - ₹ 24,00,000 per yearCompany DescriptionDyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment.Role DescriptionThis is a full-timeon-siterole for a Senior Regulatory...
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Hyderabad, India Dyaz Innovate Full timeJob Description Company Description Dyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment. Role Description This is a full-time on-site role for a...
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Senior Manager, Global Regulatory Writing
2 weeks ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 1,20,000 - ₹ 5,44,000 per yearWhat you will doIn this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standardsWrite or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4)Write CTD sections including the Summary of...
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Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 20,00,000 - ₹ 25,00,000 per yearWorking with UsChallenging. 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 transforms the...
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Senior Specialist, CMC Submission Management
3 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 12,00,000 - ₹ 36,00,000 per yearWorking with UsChallenging. 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 transforms the...
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Regulatory Affairs Manager
2 weeks ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 1,20,000 - ₹ 2,40,000 per yearJob Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a...
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Sr. Regulatory Publishing Specialist
3 days ago
Hyderabad, Telangana, India Makro Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Title: Senior Regulatory Publishing SpecialistResponsibilities:Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with...
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Submission Officer
2 weeks ago
HITEC City, Hyderabad, Telangana, India Irish Consulting Group Full time ₹ 2,40,000 - ₹ 3,00,000 per yearRole SummaryThe Submission Officer plays a crucial role in an immigration and study abroad company, responsible for managing the submission process for immigration cases and study abroad applications. This role involves liaising with clients, preparing documentation, and ensuring the timely and accurate submission of materials to relevant authorities.Duties...