DRC Specialist

6 days ago

Hyderabad Warangal Nizamabad, India Sandoz Full time
Job Description

Your responsibilities include, but not limited to:

- Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
- Partners with regions to align on regulatory strategy in order to fulfil business objectives. Implements RFP across assigned regions. 1/3. Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
- Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. Develops and implements plans for timely response to HA requests and coordinates responses.
- May serve as local HA liaison depending on location (e.g., FDA or EMA). Drives coordination, planning, and submission of dossiers in assigned regions worldwide. Review of global dossier summary documents. Develops and implements plans to avoid/minimize clock stops during submission review.
- Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs). Reviews and submits Risk Management Plans. May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.
- Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL. Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity. Contributes to and often leads the development of departmental goals and objectives.

What you ll bring to the role:

Essential Requirements:

- Minimum 5+ years of experience in Regulatory Affairs
- Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation.
- No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control.
- Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Sandoz guidelines and meets regulatory guidelines.
- Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems.
- Maintains collaborative partnerships with stakeholders.

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