Director, Commercial Regulatory Europe

Cytokinetics (Switzerland) GmbH; Zug; Vor Ort; CHF 200.000 - 250.000; Vollzeit

Zusammenfassung

Cytokinetics is seeking a highly experienced Director, Commercial Regulatory Affairs to join the Regulatory Affairs team in Europe. The role leads the European MLR process, ensures compliant promotional materials, and partners with Commercial, Medical, Legal and Compliance to support business objectives.

The ideal candidate has 8+ years in European regulatory affairs, deep knowledge of EFPIA Code, and experience with Veeva PromoMats.

Qualifikationen

• 8+ years of experience in European regulatory affairs.
• Experience in advertising and promotion regulatory roles; ABPI experience advantageous.
• Experience working with cross-functional EU teams.
• Knowledge of EFPIA Code and regulatory guidance.

Aufgaben

• Lead the European MLR process for promotional and non-promotional materials.
• Provide regulatory training and guidance to internal teams on requirements and best practices.
• Oversee local MLR activities through vendors; liaise with central regulatory affairs team.
• Ensure advertising and promotion activities comply with applicable regulations and Codes of Practice.
• Develop and implement regional MLR SOPs across countries.

Kenntnisse

Regulatory affairs

Leadership

Cross-functional collaboration

Veeva PromoMats

Communication skills

Tools

Veeva PromoMats

Jobbeschreibung

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

Cytokinetics is seeking a highly experienced Director, Commercial Regulatory Affairs, to join the Regulatory Affairs team in Europe. He/she 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. He/she will help develop the infrastructure of the Regulatory Affairs Advertising and Promotion in Europe, including MLR process development in EU countries where Cytokinetics is launching a product. The ideal candidate will possess a strong experience and understanding of regulatory and Code of Practice requirements and processes related to promotion, excellent organizational skills, and the ability to work effectively with cross-functional and international teams to 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 MLR activities: Develop and oversee the local MLR 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, Commercial, Medical, Legal and Compliance teams, to ensure regulatory activities are conducted timely and compliantly.
• Regulatory Compliance: Ensure all Advertising and Promotion activities are conducted in compliance with applicable regulations, guidelines and Codes of Practice, maintaining up-to-date knowledge of regulatory requirements in each country’s jurisdiction.
• Standard Operations Procedures development: work cross functionally to ensure all relevant MLR SOPs at regional and local levels are in place.
• Other responsibilities may be assigned as appropriate.

Qualifications

• Seasoned professional with a minimum of 8 years of relevant experience with solid expertise and knowledge of the applicable European regulations, directives and guidelines, and EFPIA Code.
• Prior experience in advertising and promotion regulatory roles is a must; ABPI experience is of advantage.
• Must have experience dealing with cross-functional teams across the EU countries.
• Must have solid understanding of clinical trial designs and results, and how the non-clinical and clinical evidence can compliantly be used for substantiation of promotional and non-promotional claims.
• Must have experience with electronic approval systems, preferably Veeva PromoMats.
• Excellent communication abilities to effectively communicate regulatory concepts cross functionally, and excellent leadership skills.
• 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.

Pay Range

Pay Range: The salary range for this role is CHF 200,000-CHF 250,000 gross annually. Final compensation will depend on skills, experience, and internal equity considerations.

In line with Switzerland equal pay regulations, we apply objective, gender-neutral criteria to determine compensation. We actively monitor pay equity through our annual Gender Equality Index and are committed to maintaining fair and transparent pay practices. In compliance with Switzerland pay transparency legislation, compensation for this role is based on objective criteria and is aligned with our company-wide salary register. We are committed to ensuring equal pay for work of equal value.

Our employees come from different backgrounds, and we celebrate those differences.

If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.