The Regulatory CMC Manager/Senior Manager Writer focuses on providing and driving creation of global CMC regulatory documentation for biologic projects/products covering development, registration and approval/post approval activities.
1. Author/Co-author high-quality CMC regulatory documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance.
2. As early as possible, identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
3. Translate the required source documentation into global submission documentation, identifying any content, quality and/or timeliness issues.
4. Contribute to defining the global regulatory strategy, identifying the critical issues and sharing lessons learned.
5. Facilitate consistency within the CMC regulatory documentation by sharing experience and/or contributing to template maintenance.
6. Establish and maintain sound working relationships with partners and customers.
7. Prepare briefing books for Health Authority meetings
8. Prepare and communicate Lessons Learned exercises on major submissions with subteams and escalate with management as appropriate.
9. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
10. Assume specialized assignments as assigned and represent own department in cross-functional project teams.
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. Biochemistry, Biotechnology, Biology) or equivalent
Desirable: Advanced Degree in Science (e.g. Biochemistry, Biotechnology, Biology) or equivalent.
Fluent English required (oral and written).
1. Minimum 2-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
2. Working knowledge of biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
3. Knowledge/experience of regulations, guidelines for new biologic entities (NBE) and product life cycle maintenance desirable.
4. Proven track record to successfully work in interdisciplinary teams, planning, coordinating, leading activities simultaneously on multiple projects.
5. Regularly demonstrated active contributions to line functions or project teams, as well as ability to contribute to matrix teams with the necessary strategic thinking.
6. Demonstrated ability for strategic thinking, maintaining awareness of business impact.
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. Reasonable approach to risk assessment.
10. Excellent written/spoken communication and negotiation skills.
11. Computer literacy.
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