Regulatory Affairs Lead

Orion

. Develop and implement regulatory strategies across Orion Pharma’s human pharmaceutical product portfolio .

Posted 10/22/2026full-timeEspoo • FinlandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory affairs for pharmaceutical products, with a strong focus on European pharmaceutical legislation and compliance. Proven ability to lead cross-functional teams and effectively communicate with regulatory authorities and partners.

Highest-signal resume keywords

Regulatory Affairs ExperienceEuropean Pharmaceutical LegislationProduct Lifecycle ManagementExcellent Communication SkillsFluent English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategies DevelopmentMarketing Authorisation ApplicationsGxP ComplianceRegulatory ProceduresRegulatory Insight and Guidance

Soft Skills

Teamwork SkillsProactive MindsetDecision-Making SkillsRelationship BuildingPersonal Leadership

Certifications & Qualifications

Approved Medical ExaminationSecurity Clearance

Industry Keywords

Pharmaceutical ProductsRegulatory AffairsLifecycle ManagementInternational SettingRegulatory Authorities

About the role

Key responsibilities & impact

Develop and implement regulatory strategies across Orion Pharma’s human pharmaceutical product portfolio
Lead regulatory activities throughout product lifecycle management
Provide strategic regulatory insight and guidance to product lifecycle teams
Develop and improve regulatory affairs working processes
Ensure GxP practices, regulatory procedures, systems and processes comply with relevant guidelines
Coordinate regulatory affairs activities internally and externally
Lead communications and meetings with regulatory authorities and partners
Lead cross-functional teams and represent regulatory affairs in teams and projects
Work closely with internal functions, external partners and regulatory authorities
Report to the Head of Global Regulatory Affairs, LCM

Requirements

What you’ll need

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
Excellent communication and teamwork skills
Ability to build effective relationships in an international setting
Proactive, solution-oriented mindset
Sound decision-making skills
Strong personal leadership
Fluent written and spoken English
Fluent Finnish is a strong advantage
Approved medical examination including drug testing required prior to employment
Security clearance required prior to employment

Benefits

Comp & perks

Permanent, full-time position
Hybrid working model
Development opportunities aligned with role and experience
Opportunities to deepen regulatory expertise and build new capabilities
Career paths and development opportunities
Collaborative team and international working environment
Safe working environment
Diversity, friendliness, respect and mutual appreciation culture