Senior Regulatory Strategy Lead – Global Pharma (Hybrid)

Orion Pharma; Turku; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Orion Pharma is seeking a Regulatory Affairs Lead to shape regulatory strategies and lead activities across a diverse product portfolio. Based in Finland, the role collaborates with internal teams, partners, and authorities to deliver effective lifecycle solutions.

The position is permanent and full-time, based at Espoo or Turku with Orion's hybrid working model. Ideal candidates bring about 10 years of regulatory experience, strong communication skills, and fluency in English (Finnish is a

Qualifications

• A suitable academic background, such as an M.Sc. in Pharmacy, Life Sciences or a related field.
• Approximately 10 years of experience in regulatory affairs for pharmaceutical products, including marketing authorisation applications or variations.
• Strong knowledge of European pharmaceutical legislation, guidance and regulatory procedures, together with curiosity about the evolving regulatory environment.
• Excellent communication and teamwork skills, with the ability to build effective relationships in an international setting.
• A proactive, solution-oriented mindset, sound decision-making skills and strong personal leadership.
• Fluent written and spoken English; fluent Finnish is a strong advantage.

Responsibilities

• Regulatory Intelligence: provide strategic regulatory insights for product lifecycle management and help navigate evolving regulations.
• Regulatory Guidance: offer clear, practical regulatory guidance to lifecycle teams.
• Regulatory Compliance: develop and continuously improve regulatory processes, ensuring GxP practices comply with guidelines.
• Regulatory Interactions: coordinate activities with authorities and partners, lead cross-functional teams.

Skills

Regulatory affairs

Regulatory strategy

Communication

Leadership

Teamwork

English fluency

Finnish language

Education

M.Sc. in Pharmacy

Life Sciences degree

Job description

Orion Pharma is seeking a Regulatory Affairs Lead to shape regulatory strategies and lead activities across a diverse product portfolio. Based in Finland, the role collaborates with internal teams, partners, and authorities to deliver effective lifecycle solutions.

The position is permanent and full-time, based at Espoo or Turku with Orion's hybrid working model. Ideal candidates bring about 10 years of regulatory experience, strong communication skills, and fluency in English (Finnish is a