Associate, Regulatory Affairs

Overview of Role:

The Associate of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, clinical studies, coordination of regulatory submission processes and maintenance of submission timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

Role and Responsibilities:

• Provide support of molecule and study-level regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the studies as necessary under direction of the Regulatory Affairs Lead.
• Prepare and coordinate routine and lifecycle submissions and related activities under the guidance of the RA Lead
• Support development of regulatory content for BLA, NDA and/or ex-US marketing applications
• Prepare and communicate regulatory status, timelines, risks, and action items to the RA lead and cross-functional study team.
• Maintain trackers for health-authority requests, responses, commitments, and due dates; coordinate subject-matter expert input under RA lead supervision.
• Collaborate with the Project Team representatives in the planning of regulatory documents, including Health Authority Meetings and responses to Health Authority queries
• Coordinate the review, finalization, and approval workflows for regulatory submissions
• Maintain accurate regulatory and, where applicable, ethics submission and approval trackers for assigned studies
• Maintain regulatory archives in collaboration with Regulatory Operations
• Support global regulatory submissions and strategic planning as applicable

• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• BA/BS degree in the biological or health related sciences required
• Relevant (bio) pharmaceutical industry experience, including experience in regulatory affairs
• Foundational understanding of the drug-development process and applicable regulatory concepts, including FDA regulations, ICH guidelines, and Good Clinical Practice; willingness to develop knowledge of ex-U.S. requirements.
• Proficient in written, oral, and interpersonal communications in English
• Ability to work in close collaboration with cross-functional colleagues
• Strong attention to detail and ability to organize, prioritize, and complete assigned work within established timelines.
• Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred as well as ex-US Health Authority interactions, meetings etc.
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Clear and concise oral and written communication skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to complete assigned work with appropriate guidance and escalate questions or risks promptly.
• Ability to work effectively in a dynamic, deadline-driven, and collaborative environment.