3.0 - 5.0 years

3 - 5 Lacs

hyderabad, telangana, india

On-site

Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and...

Posted 4 months ago

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RA CMC Senior Manager Sandoz

4.0 - 6.0 years

4 - 6 Lacs

hyderabad, telangana, india

On-site

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Regulatory Affairs Intelligence Mgr Amgen Technology Private Limited

3.0 - 5.0 years

2 - 6 Lacs

Hyderabad, Telangana, India

On-site

Key Responsibilities Intelligence Gathering & Analysis Monitor and analyze the global regulatory landscape for assigned therapeutic or regional areas Compile and synthesize new or updated regulatory requirements from local affiliates Prepare deliverables such as monitoring reports, bulletins, and landscape summaries Ensure outputs are clear, actionable, and aligned with business needs Provide insights or recommendations to inform filing strategies and compliance planning Tools & Data Management Manage and maintain regulatory intelligence tools, databases, and repositories Ensure systems are up-to-date and easily accessible by stakeholders Build or configure new dashboards, tracking tools, or...

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