Role Overview:
Cytokinetics is seeking a Senior Director, who leads Commercial Regulatory Affairs and Business Operations for Europe, ensuring promotional materials and activities comply with regional/local regulations while supporting the company’s commercial goals. They oversee regulatory operations, collaborate with European affiliates and vendors, and drive process improvements within the Regulatory Affairs department.
Key Responsibilities:
- Lead and manage the European Medical, Legal, Regulatory (MLR) review process for promotional materials.
- Provide training and guidance on regulatory requirements for promotional and other activities.
- Oversee local regulatory activities through vendor management and serve as liaison between central and local teams.
- Collaborate cross-functionally with Pharmacovigilance, Quality, Commercial, and Medical teams to ensure compliance and timely execution.
- Maintain up-to-date knowledge of European regulatory policies and ensure compliance.
- Develop and implement regulatory SOPs at regional and local levels.
- Manage budget and resource planning for the European regulatory department.
- Identify and implement process improvements to enhance efficiency and compliance.
- Monitor regulatory policy changes in Europe and communicate their business impact.
Qualifications:
- Minimum 12 years of relevant experience with deep expertise in European regulatory regulations, especially around promotional activities.
- Proven experience working with EU regulatory authorities.
- Strong knowledge of quality and GxP standards.
- Excellent leadership, communication, organizational, and interpersonal skills.
- Ability to work effectively in cross-functional, matrixed environments.
- Proactive problem-solver with strong planning and time management skills.
Job sourced from Cytokinetics.