Regulatory Affairs Specialist, Oncology Therapy Area, Research & Development

Orion Pharma•Boston, MA

3d•$100,000 - $150,000

About The Position

We are seeking a Regulatory Affairs Specialist to support U.S. and global regulatory activities for development-stage pharmaceutical programs. This role is well suited for an early-career regulatory professional looking to deepen hands-on experience across clinical development, regulatory submissions, and cross-functional collaboration, with exposure to oncology programs preferred but not required. The successful candidate will work under the guidance of more senior regulatory team members and contribute to the preparation, maintenance, and execution of regulatory deliverables across multiple development programs. This role is based in Cambridge, Massachusetts, US. At Orion Pharma, your work contributes to improving health and well-being for patients and society. We foster a culture of respect, diversity, and collaboration, offering: Inclusive work environment Opportunities for professional growth and development A chance to be part of a mission-driven organization Learn more about our values and working culture: https://www.orion.fi/en/careers/orion-asan- employer/ Orion Pharma’s pharmaceutical innovations are created within its R&D organization. We employ around 400 top professionals in the field of drug discovery and development. We work globally: in Espoo and Turku in Finland, in Cambridge and Nottingham in England and in Cambridge, MA, USA. Orion R&D and the Innovative Medicines business division are dedicated to making a transformation to become a global player in the pain and oncology therapy areas.

Requirements

Bachelor’s degree in life sciences, pharmacy, public health, or a related field (advanced degree a plus).
At least 2 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
Basic understanding of U.S. and/or EU regulatory frameworks for clinical development.
Experience supporting regulatory submissions or regulatory documentation.
Strong attention to detail, organizational skills, and ability to manage multiple tasks in parallel.
Clear written and verbal communication skills.
The ideal candidate is detail-oriented with a strong quality mindset, collaborative and comfortable working in cross-functional teams.
They are curious and motivated to grow their regulatory expertise, able to operate effectively in a fast-paced development environment, and receptive to feedback with a genuine eagerness to learn and adopt regulatory best practices.

Nice To Haves

Experience supporting oncology development programs (preferred but not required).
Familiarity with INDs, CTAs, or global clinical trial applications.
Exposure to eCTD structure and publishing workflows.
Experience working with CROs or external regulatory vendors.
Working knowledge of regulatory systems (e.g., document management systems, submission tracking tools).

Responsibilities

Regulatory Submissions & Documentation Support preparation, compilation, and maintenance of regulatory submissions (e.g., INDs, amendments, annual reports, briefing documents, CTAs).
Assist with eCTD publishing coordination and document lifecycle management in collaboration with Regulatory Operations or external vendors.
Perform quality control (QC) checks to ensure regulatory documents are complete, accurate, and submission-ready.
Regulatory Strategy Support Contribute to the execution of regulatory strategies as defined by Regional Regulatory Experts or Global Regulatory Leads.
Assist with regulatory intelligence gathering (e.g., guidance review, precedent research) to support development decisions.
Track regulatory commitments, milestones, and agency feedback.
Cross-Functional Collaboration Work closely with Clinical Development, Clinical Operations, Medical Writing, CMC, and external partners to gather required inputs for submissions.
Support coordination of internal review cycles and comment reconciliation.
Participate in cross-functional meetings and maintain clear documentation of decisions and action items.
Health Authority Interactions (Supportive Role) Assist in preparation of materials for health authority interactions (e.g., FDA, EMA).
Support documentation of meeting outcomes and follow-up actions.
Operational & Process Support Maintain regulatory trackers, timelines, and submission plans.
Support inspection readiness activities and document archiving.
Contribute to continuous improvement of regulatory processes, templates, and ways of working.