Global Regulatory Lead - Strategy & Lifecycle (Hybrid)

Orion Corporation; Espoo; Hybrid; EUR 110,000 - 150,000; Full time

Job summary

Orion Pharma is seeking a Regulatory Affairs Lead to develop and implement regulatory strategies for a broad human pharmaceutical portfolio. You will provide regulatory direction, coordinate authorities, and lead cross-functional teams in lifecycle management.

The role is permanent and full-time, based in Espoo or Turku with Orion’s hybrid working model, reporting to the Head of Global Regulatory Affairs, LCM, and requiring about 10 years in regulatory affairs and an MSc in Pharmacy or Life

Qualifications

• M.Sc. in Pharmacy, Life Sciences or related field.
• About 10 years in regulatory affairs for pharmaceutical products.
• Strong knowledge of European pharmaceuticals legislation and procedures.
• Excellent communication and teamwork in international settings.
• Fluent written and spoken English; Finnish is a plus.

Responsibilities

• Shape regulatory strategies across a broad product portfolio.
• Lead regulatory activities and interactions with authorities.
• Develop and improve regulatory processes and ensure GxP compliance.
• Coordinate cross-functional teams and partner with external bodies.

Skills

Regulatory affairs

Pharmaceutical knowledge

Regulatory strategy

English proficiency

Finnish language

Education

M.Sc. in Pharmacy/Life Sciences

Job description

Orion Pharma is seeking a Regulatory Affairs Lead to develop and implement regulatory strategies for a broad human pharmaceutical portfolio. You will provide regulatory direction, coordinate authorities, and lead cross-functional teams in lifecycle management.

The role is permanent and full-time, based in Espoo or Turku with Orion’s hybrid working model, reporting to the Head of Global Regulatory Affairs, LCM, and requiring about 10 years in regulatory affairs and an MSc in Pharmacy or Life