Regulatory Affairs Specialist, Oncology Therapy Area

Orion

Regulatory Affairs Specialist at Orion Pharma supporting EU and global regulatory activities for oncology programs. Join a collaborative global team to deepen experience in regulatory submissions.

Posted 5/27/2026full-timeEspoo • 🇫🇮 FinlandJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

Regulatory Submissions: Support the preparation, compilation, and maintenance of regulatory submission packages (e.g. Clinical Trial Applications (CTAs) via CTIS, INDs, amendments, annual reports, briefing documents). Coordinate eCTD publishing and document lifecycle management in collaboration with Regulatory Operations or external vendors. Perform quality control checks to ensure submission documents are complete, accurate, and compliant.
Regulatory Strategy Support: Execute regulatory strategy tasks as defined by senior team members (Regional Regulatory Leads/Global Regulatory Leads). Gather regulatory intelligence to support development decisions. Track regulatory commitments, key milestones, and health authority feedback for ongoing projects.
Cross-Functional Collaboration: Collaborate closely with Clinical Development, Clinical Operations, Nonclinical Development, Medical Writing, CMC, and external partners to gather necessary data and documents for submissions. Assist in coordinating internal review cycles, consolidating feedback, and ensuring timely approvals of documents. Actively participate in relevant meetings and document key decisions and action items.
Health Authority Interactions: Assist in preparing for health authority meetings and correspondence, primarily with European authorities (EMA) and FDA. Support the team in developing meeting briefing packages, rehearsing meeting content, and documenting outcomes and follow-up actions from agency interactions.
Operational & Process Excellence: Maintain internal regulatory trackers, timelines, and submission plans to ensure on-time execution. Support inspection readiness activities and proper archiving of regulatory documents. Contribute to continuous improvement of internal processes, templates, and best practices within the regulatory affairs function.

Requirements

What you’ll need

Education: Bachelor’s or Master’s degree in life sciences, pharmacy, or a related field
Experience: Approximately 2+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry (clinical development stage focus / CRO preferred). Experience supporting oncology or other complex therapeutic area development programs is preferred.
Regulatory Knowledge: Basic understanding of European regulatory frameworks for drug development (e.g. CTA process and CTIS) and familiarity with global requirements (such as US IND process). Experience in preparing or supporting regulatory submissions or documentation is required. Exposure to eCTD structure and electronic publishing workflows. Experience using regulatory document management systems or submission tracking tools. Prior experience working with CROs or external regulatory vendors.
Skills: Strong attention to detail, excellent organizational abilities, and the capacity to manage multiple tasks in parallel under tight timelines. Clear written and verbal communication skills in English are essential. Ability to work effectively in cross-functional teams and adapt in a dynamic, fast-paced environment. A proactive, quality-driven mindset with eagerness to learn and adopt regulatory best practices.

Benefits

Comp & perks

Impactful Work: An opportunity to be part of a mission-driven organization where your contributions in regulatory affairs help advance new treatments for patients and society.
Collaborative Culture: A supportive, inclusive work environment rooted in Nordic values of trust, openness, and collaboration. We value each team member’s input and foster continuous learning and development. We provide continuous support and comprehensive onboarding to help you develop your capabilities and succeed as part of the team.
Growth & Development: Opportunities for professional growth, mentoring from experienced regulatory leaders, and exposure to innovative oncology and pain therapy area R&D projects in a global setting.
Competitive Compensation: A competitive salary and benefits package aligned with your experience and local market standards, plus flexible/hybrid working arrangements.

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsclinical trial applicationseCTD publishingquality controlregulatory strategyregulatory intelligencesubmission trackingregulatory document management systemsoncology development programsEuropean regulatory frameworks

Soft Skills

attention to detailorganizational abilitiesclear communicationcross-functional collaborationadaptabilityproactive mindsetquality-driven mindsetcapacity to manage multiple taskseagerness to learnparticipation in meetings