Orion Pharma is currently hiring a Regulatory Affairs Specialist within the Oncology Therapy Area for its Research & Development team. This exciting opportunity is based in Cambridge, Massachusetts, offering a hybrid work model for professionals looking to grow their careers in global pharmaceutical regulatory affairs.
This role is ideal for early-career regulatory professionals with at least two years of experience in pharma or biotech regulatory affairs, especially those interested in contributing to innovative oncology research and development programs.
About Orion Pharma
Orion Corporation (commonly known as Orion Pharma) is a globally recognized Nordic pharmaceutical company headquartered in Espoo, Finland. With more than 100 years of pharmaceutical innovation, Orion focuses on improving patient well-being through the development of human and veterinary medicines.
Company Highlights
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Over 4,000 employees across 35+ countries
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Global R&D sites in Finland, the UK, and the United States
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Strong focus on oncology, pain management, neurological diseases, respiratory disorders, and women’s health
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A culture rooted in Nordic values such as trust, transparency, collaboration, and ethical conduct
Orion continues to invest heavily in research and development to advance innovative therapies for serious diseases, particularly in oncology.
Job Details – Regulatory Affairs Specialist
Company: Orion Pharma
Department: Research & Development – Regulatory Affairs
Role: Regulatory Affairs Specialist (Oncology Therapy Area)
Experience Required: Minimum 2 years in Regulatory Affairs
Qualification: Bachelor’s degree in Life Sciences, Pharmacy, Public Health, or related field (advanced degree preferred)
Location: Cambridge / Boston, Massachusetts, USA
Work Type: Full-time, Hybrid
Role Overview
The Regulatory Affairs Specialist will support global regulatory activities for development-stage pharmaceutical programs, particularly in oncology. The position involves working closely with cross-functional teams to support clinical development and regulatory submissions.
This is an excellent opportunity for professionals who want to gain hands-on experience with regulatory strategy, submissions, and health authority interactions.
Required Skills & Qualifications
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Minimum 2 years of experience in regulatory affairs within the pharma or biotech industry
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Knowledge of U.S. FDA and/or EU regulatory frameworks for clinical development
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Experience with regulatory submissions and documentation
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Familiarity with eCTD publishing and submission workflows
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Strong organizational and documentation skills
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Excellent written and verbal communication abilities
Preferred Skills
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Experience in oncology development programs
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Exposure to INDs or CTAs
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Experience collaborating with CROs or regulatory vendors
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Familiarity with regulatory systems and submission management tools
Key Responsibilities
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Prepare and compile regulatory submissions including INDs, amendments, annual reports, and CTAs
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Coordinate eCTD publishing and document lifecycle management
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Perform quality checks on submission-ready regulatory documents
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Support regulatory strategy implementation and intelligence gathering
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Collaborate with Clinical Development, Medical Writing, CMC, and Operations teams
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Assist in preparations for interactions with health authorities
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Maintain submission trackers, timelines, and documentation archives
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Support process improvements and regulatory best practices
Salary and Benefits
Expected Salary Range: $100,000 – $150,000 per year
(Final compensation depends on experience, qualifications, and skills.)
Benefits Include
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Hybrid work flexibility
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Global exposure in pharmaceutical R&D
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Opportunities for professional development and career growth
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Collaborative and inclusive Nordic work culture
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Participation in innovative oncology research programs
Application Process
Candidates interested in the Orion Pharma Regulatory Affairs Specialist role should submit:
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Updated CV
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Cover Letter
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Salary expectations
Application Deadline: March 22, 2026
Applications should be submitted through the official Orion Pharma careers portal or LinkedIn job posting.
Background Context: Regulatory Affairs Careers in Oncology
Regulatory Affairs professionals play a critical role in bringing new medicines to market. In oncology R&D, regulatory teams coordinate with clinical researchers, regulatory authorities, and global development teams to ensure therapies meet strict safety and efficacy standards.
Major regulatory agencies overseeing drug approvals include:
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U.S. Food and Drug Administration
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European Medicines Agency
These authorities evaluate clinical trial data, regulatory submissions, and manufacturing processes before approving new therapies for patient use.
With the rapid growth of oncology research worldwide, demand for experienced regulatory professionals continues to rise.
Why Join Orion Pharma?
Working at Orion Pharma offers a unique combination of Nordic corporate values and global pharmaceutical innovation.
Employees benefit from:
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A culture of trust, openness, and collaboration
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Opportunities to work on high-impact oncology therapies
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A supportive environment encouraging continuous learning and professional growth
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Participation in projects that directly improve patient lives
For regulatory professionals seeking meaningful work in drug development, Orion provides a platform to grow while contributing to life-saving therapies.
FAQs
What experience is required for this role?
Candidates must have at least 2 years of regulatory affairs experience in the pharmaceutical or biotech industry.
Is oncology experience mandatory?
No, but oncology exposure is preferred.
Is the role remote?
The position follows a hybrid model based in Cambridge, Massachusetts.
What is the application deadline?
Applications must be submitted by March 22, 2026.