Senior Director, Commercial Regulatory Affairs and Business Operations - Europe na Cytokinetics

Cytokinetics is seeking a highly experienced Senior Director, Commercial Regulatory Affairs and Business Operations, to join the Regulatory Affairs team in Europe. They will play a key role in ensuring that all promotional materials and activities comply with regional and local regulatory requirements, aligning with the company's commercial objectives. This role is also pivotal in ensuring the efficient and compliant operation of our regulatory affairs department, with a focus on collaborating with the general managers and regulatory local vendors across our affiliates in Europe. They will help develop the infrastructure of the Regulatory Affairs Department in Europe, including implementation of process improvements to enhance the efficiency of operations as well as oversight of regulatory policy changes in Europe and their impact on business operations.

The ideal candidate will possess a strong experience and understanding of regulatory requirements and processes related to promotion and commercialization, excellent organizational skills, and the ability to work effectively with cross-functional teams to streamline operations and support business objectives.

Responsibilities

• Advertising and promotional activities: Lead and manage the European MLR process, ensuring timely and compliant regulatory review of promotional and non-promotional materials in Europe.
• Training and Guidance: Provide training and guidance to internal teams on regulatory requirements and best practices for promotional activities and other activities as required.
• Oversight of local regulatory activities: Develop and oversee the local regulatory activities through vendor selection, management and serve as the primary liaison between the central regulatory affairs team and local regulatory vendors, ensuring alignment of regulatory strategies and objectives.
• Cross-Functional Collaboration: Work closely with internal departments, including Pharmacovigilance, Quality Assurance, Commercial and Medical teams, to ensure regulatory activities are conducted timely and compliantly.
• Regulatory Compliance: Ensure all regulatory activities are conducted in compliance with applicable regulations and guidelines, maintaining up-to-date knowledge of regulatory requirements in each country’s jurisdiction.
• Standard Operations Procedures development: work cross functionally to ensure all relevant regulatory SOPs at regional and local levels are in place.
• Budget management: Help manage and coordinate budget of the regulatory department in Europe and provides input into budgeting and resource requirements.
• Process Improvement: Identify opportunities for process enhancements within the regulatory affairs function to increase efficiency and compliance.
• Regulatory Intelligence: Oversee the regulatory policy requirements changes in Europe and ensure timely communication of impacts to relevant stakeholders.

Qualifications

• Seasoned professional with a minimum of 12 years of relevant experience with solid expertise and knowledge of the applicable European regulatory regulations, directives and guidelines
• Strong experience understanding of European regulatory requirements, particularly concerning promotional activities. Prior experience in advertising and promotion regulatory roles is a must.
• Must have experience dealing with regulatory representatives in the EU countries.
• Must have solid understanding of quality and GxP standards.
• Excellent communication and leadership skills.
• Ability to work effectively in a cross-functional, matrixed environment.
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Strong interpersonal capabilities and ability to build and maintain networks.
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.