Work As A Regulatory CMC Senior Manager @ Novartis
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
Job Title: Regulatory CMC Senior Manager
Eligibility: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) Fluent English required (oral and written). Good skills in site (local) language desired (oral)
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 newchemical 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 simultaneously 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
Independently, provide strategic and operational global CMC regulatory direction and documentation for projects/ products within responsibility covering development, registration and approval/ post approval activities as assigned.
1.Formulate, lead and drive 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 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 applying 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 rehearsals 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), contingency plans and Lessons Learned on major submissions and escalate to management as appropriate.
10.Keep knowledge up to date with regard to regulatory guidelines and requirements 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 department.
13.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
14.Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate documentation on matters within CMC control.
15.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.
16.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).
17.Provide regulatory evaluation and advice on time and of high quality (change control, etc.); regulatory compliance met (DRAGON, etc.).
18.No last minute source document issues identified that could have been prevented by early review of source documents.
19.Positive customer feedback