Independently, provide strategic and operational global CMC regulatory direction and documenta-tion for projects/products within responsibility covering development, registration and approv-al/post approval activities as assigned
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.
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.
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.
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.
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.
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.
Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning re-hearsals and risk mitigation plans.
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.
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.
Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends.
Represent Reg CMC on due diligence teams for in-licensing and divestment opportunities.
Represent Reg CMC on teams for continuous improvement within the depart-ment.
Provide advice and direction within the department within specialized assign-ments as assigned.
Represent REG CMC at Global Supply Support Teams (SST), Regulatory review boards and other teams and boards as appropriate.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
Languages: Fluent English required (oral and written). Good skills in site (local) language desired (oral)
Experience/Professional requirement: 1. 4-6 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
2. Working knowledge/experience in regulatory submission and ap-proval processes for new chemical entities (NCE) and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements.
3. Proven track record of successfully working in interdisciplinary teams and planning, coordinating and leading activities simultane-ously on multiple projects.
4. Regularly demonstrated active contributions to line functions or project teams, as well as ability to contribute to matrix teams with the necessary strategic thinking.
5. Demonstrated ability for strategic thinking, maintaining awareness of business impact.
6. Demonstrated ability for risk assessment and mitigation.
7. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
8. Effective planning, organizational and interpersonal skills.
9. Excellent written/spoken communication, negotiation skills and problem solving skills.
10. Computer literacy.
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