Regulatory Affairs Specialist, Oncology Therapy Area, Research & Development

Orion Corporation; Espoo; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Competitive salary and benefits

Opportunities for professional growth

Collaborative culture

Job summary

Orion Corporation in Espoo, Finland is seeking a Regulatory Affairs Specialist to support EU and global regulatory activities for oncology and pain programs.

The role involves preparing regulatory submissions and collaborating with cross-functional teams to ensure compliance. Ideal candidates will have 2+ years of experience in Regulatory Affairs and possess strong communication skills in English.

This position offers a hybrid work model, competitive compensation, and opportunities for professional growth.

Qualifications

• Approximately 2+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
• Basic understanding of European regulatory frameworks for drug development.
• Experience in preparing or supporting regulatory submissions or documentation.

Responsibilities

• Support preparation, compilation, and maintenance of regulatory submission packages.
• Execute regulatory strategy tasks as defined by senior team members.
• Collaborate closely with cross-functional teams to gather necessary data.

Skills

Attention to detail

Organizational abilities

Written communication in English

Verbal communication in English

Ability to work in teams

Education

Bachelor’s or Master’s degree in life sciences, pharmacy, or related field

Tools

Regulatory document management systems

eCTD structure and electronic publishing workflows

Job description

Regulatory Affairs Specialist, Oncology Therapy Area, Research & Development

Espoo, Finland and 2 more (Hybrid)

Job Description

Orion Pharma’s Research and Development is looking for a Regulatory Affairs Specialist to support EU and global regulatory activities for our oncology and pain development‑stage pharmaceutical programs.

In this role, you will work under the guidance of senior regulatory professionals to prepare and manage regulatory submissions and contribute to cross‑functional project teams within R&D. This is an excellent opportunity for a junior‑to‑mid level regulatory professional to deepen hands‑on experience in clinical development and regulatory submissions. You will be part of a global team with colleagues based in the United States, United Kingdom, and Finland.

Key Responsibilities

• 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.

Qualifications

• 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

• 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.
• 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.

Location

This role can be based in our R&D locations within the United Kingdom or Finland. The position is offered on a hybrid basis at Espoo, Finland and additional locations.