pharma4u

Post : Regulatory CMC Manager

Job Description
Major Accountabilities 
1. Formulate and lead global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing 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 in-terdisciplinary 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. Prepare and communicate CMC dossier risk analyses (SWOTS), contingency plans and Lessons Learned on major submissions with subteams and escalate with management 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. Assume specialized assignments as assigned and represent Reg CMC in cross functional project teams.
12. Represent REG CMC at Global Supply Support Teams (SST), Regulatory review boards and other teams and boards as appropriate

Key Performance Indicator 
1. Quality of strategic project documentation and presentations: Documentation of high quality (e.g. meeting agenda and minutes, project plans, TEDI reports, SWOTS, Lessons Learned, etc.); no late changes in strategy due to inadequate priori evaluation.
2. Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate CMC documentation on matters within CMC control.
3. Reliable, timely and accurate information / communication about project specific issues within Reg CMC and to key stakeholders within Tech Ops, DRA and TRD as appropriate, changes in project status communicated as required.
4. Ensure that CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines, as appropriate (e.g. measured by approval of CMC documentation, and no non-approvals due to CMC issues under our control).
5. Provide regulatory evaluation and advice on time and of high quality (change control, etc.); regulatory compliance met (DRAGON, etc.).
6. No last minute source document issues identified that could have been prevented by early review of source documents. 7. Positive customer feedback