Exciting pharma jobs opportunity in the US! Orion Pharma is recruiting a Regulatory Affairs Specialist in the Oncology Therapy Area for its Research & Development team.
This hybrid role in Boston/Cambridge, Massachusetts, suits early-career professionals eager to gain hands-on experience in regulatory affairs jobs, clinical development, and oncology-focused submissions. Join a mission-driven Nordic pharmaceutical leader advancing innovative medicines.
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About the Company
Orion Pharma is a globally operating Nordic pharmaceutical company with over 100 years of history, dedicated to building well-being through innovative human and veterinary pharmaceuticals, generics, and consumer health products.
Headquartered in Finland, it employs more than 4,000 people (“Orionees”) across 35+ countries, with key R&D sites in Espoo and Turku (Finland), Cambridge and Nottingham (UK), and Cambridge, MA (USA). The company focuses on core therapy areas like oncology, pain, neurological diseases, respiratory diseases, and women’s health.
Orion invests heavily in R&D to develop proprietary products for cancer and other serious conditions. Recognized for its inclusive, respectful culture rooted in Nordic values of trust, openness, collaboration, continuous learning, and ethical conduct, Orion fosters professional growth, diversity, safety, and a sense of purpose—empowering employees to contribute to meaningful healthcare advancements.
Job Details
- Company Name: Orion Pharma
- Experience: At least 2 years in Regulatory Affairs (pharma/biotech industry)
- Qualification: Bachelor’s degree in life sciences, pharmacy, public health, or related field (advanced degree preferred)
- Location: Boston/Cambridge, Massachusetts, United States (Hybrid; based in Cambridge, MA)
- Work Type: Full-time, Hybrid
Job Description
This role supports U.S. and global regulatory activities for development-stage pharmaceutical programs, with a focus on oncology (preferred but not required). Ideal for early-career regulatory professionals seeking to build expertise in submissions, strategy, and cross-functional work under senior guidance.
Regulatory Affairs Specialist, Oncology Therapy Area, Research & Development
- Department: Research & Development (Regulatory Affairs)
- Role: Regulatory Affairs Specialist
- Key Focus: Support clinical development programs, regulatory submissions, and interactions for oncology and other therapies
- Experience: Minimum 2 years in regulatory affairs; exposure to INDs, CTAs, or oncology programs preferred
- Qualification: Bachelor’s in life sciences/pharmacy (advanced degree a plus)
Skills & Qualifications
- At least 2 years of regulatory affairs experience in pharmaceutical/biotech industry
- Basic knowledge of U.S. (FDA) and/or EU regulatory frameworks for clinical development
- Experience supporting regulatory submissions, documentation, or eCTD publishing
- Strong attention to detail, organizational skills, and multitasking ability
- Excellent written and verbal communication
- Preferred: Familiarity with oncology programs, INDs/CTAs, eCTD workflows, CRO/vendor collaboration, regulatory systems (document management/submission tools)
- Quality mindset, collaborative approach, curiosity, and eagerness to learn in a fast-paced environment
Key Responsibilities
- Prepare, compile, and maintain regulatory submissions (INDs, amendments, annual reports, briefing documents, CTAs)
- Coordinate eCTD publishing and document lifecycle with Regulatory Operations/vendors
- Perform QC checks on submission-ready documents
- Support execution of regulatory strategies, intelligence gathering, and commitment tracking
- Collaborate with Clinical Development, Operations, Medical Writing, CMC, and partners for inputs and reviews
- Assist in health authority interaction preparations (FDA/EMA) and document outcomes
- Maintain trackers, timelines, submission plans; support inspection readiness and archiving
- Contribute to process improvements, templates, and best practices
Benefits & Perks
- Inclusive, respectful, and collaborative work environment
- Opportunities for professional growth, development, and continuous learning
- Mission-driven culture focused on patient well-being and societal impact
- Valued employees with trust, appreciation, and voice in decision-making
- Global exposure in a responsible, ethical Nordic-rooted organization
- Contribution to innovative oncology and pain therapies
How to Apply
Submit your application in English, including latest CV, cover letter, and salary request, by March 22nd, 2026.
Apply via the official Orion Pharma careers portal or the LinkedIn posting: Regulatory Affairs Specialist – Orion Pharma
Expected salary range: $100,000–$150,000 per year (final offer based on skills, experience, and qualifications).
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Orion Pharma Page.
For more pharma jobs in regulatory affairs, oncology, or R&D, explore Pharma Recruiter or visit www.orionpharma.com/careers.
Act now—deadline approaching for this rewarding role in Cambridge, MA!
Why Join Orion Pharma?
Orion Pharma combines Nordic values with a global mindset, offering a supportive culture where employees feel heard, trusted, and inspired. With a strong emphasis on R&D innovation in oncology and pain, you’ll contribute to transformative medicines while growing professionally in a diverse, ethical environment.
It’s a chance to make a real difference in patients’ lives through high-impact regulatory work in a collaborative, learning-focused setting.
FAQs
What experience is required for this regulatory affairs job?
Minimum 2 years in regulatory affairs within pharma/biotech; oncology exposure preferred but not mandatory.
Is this role fully remote or hybrid?
Hybrid, based in Cambridge, MA (Boston area), with flexibility for on-site and remote work.
What is the application deadline and salary range?
Apply by March 22nd, 2026; expected salary $100,000–$150,000 annually, depending on qualifications.
Does Orion Pharma support career growth in regulatory and oncology?
Yes—strong focus on professional development, learning, and advancement in R&D and regulatory functions within a mission-driven global company.
