Director, European Commercial Regulatory Affairs

Cytokinetics (Switzerland) GmbH; Zug; On-site; CHF 200,000 - 250,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

Leadership

Cross-functional collaboration

Veeva PromoMats

Communication skills

Tools

Veeva PromoMats

Job description

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.