Aktuelle Jobs im Zusammenhang mit Research Leader for Regulatory Submissions - Basel, Basel-Stadt - Novartis Farmacéutica
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Research Leader for Regulatory Submissions
vor 2 Wochen
About the Role
The Biomedical Research Submission Management, Associate Director position at Novartis Farmacéutica is a high-impact leadership role that requires strong expertise in regulatory affairs and project management.
Key responsibilities include leading cross-functional submission teams to ensure timely preparation of regulatory submissions in compliance with authority regulations, company SOPs, and quality standards.
- Develop comprehensive strategic submission plans, detailing dossier content, key activities, and timelines.
- Provide strategic input on submission requirements for migration of supporting documentation for licensed assets.
- Maintain group knowledge of evolving submission requirements and develop strategies to prepare the organization for future changes.
- Participate in audits and inspections, executing corrective action plans as necessary.
Requirements
To be successful in this role, you will need:
- An undergraduate degree in a scientific discipline or life science background, or equivalent work experience.
- 5-10 years' experience working in a regulated life science environment, with 2-3 years' experience as a people manager.
- Project management experience in the pharmaceutical industry or regulatory environment.
- Expert knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV.
- Demonstrated leadership and negotiation skills to persuade and influence others in achieving team and submission objectives.
