Regulatory Cmc Manager jobs, jobs in Hyderabad, Jobs in Novartis Hyealthcare Pvt. Ltd.

Novartis Hyealthcare Pvt. Ltd.

Hyderabad

Key Skills: Regulatory CMC Manager, CMC regulatory strategy, CMC Documentation . Formulate, lead and drive global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, max-imizing the business benefit balanced with regulatory compliance. 2. (more) Key Skills: Regulatory CMC Manager, CMC regulatory strategy, CMC Documentation . Formulate, lead and drive global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, max-imizing the business benefit balanced with regulatory compliance.

2. Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in Reg CMC, DRA, TechOps and TRD as appropriate.

3. Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while ap-plying the global strategy into submissions.

Make quality regulatory decisions, balancing risks and benefits. 4.

As early as possible, identify the required documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. 5.

Author high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. 6.

Establish and maintain a single point of contact with FDA or CPOs, DRA regional and TA groups for all communication on development and marketed products. Establish and maintain sound working relationships with partners and customers.

7. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning re-hearsals and risk mitigation plans.

8. Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, and prepare CMC responses, as appropriate.

9. Lead, prepare and communicate CMC dossier risk analyses (SWOTS), contin-gency plans and Lessons Learned on major submissions and escalate to man-agement as appropriate.

10. Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends.

11. Represent Reg CMC on due diligence teams for in-licensing and divestment opportunities.

12. Represent Reg CMC on teams for continuous improvement within the depart-ment.

13. Provide advice and direction within the department within specialized assign-ments as assigned.

14. Represent REG CMC at Global Supply Support Teams (SST), Regulatory review boards and other teams and boards as appropriate (less)

Health Care / Medical Services / Hospitals

source: search.clickjobs.com

19 Feb 2013

Search result "Cmc " : 215 matches.

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