(Sr.)/Regulatory Affairs Specialist (Remote)

About the Role

We are seeking a Senior Associate with substantial experience planning and managing regulatory authority submissions. In this role, you will independently manage multiple clinical programs with limited supervision, contribute to major submissions and responses to regulatory authorities related to IND/NDA submissions and amendments, support the preparation of briefing packages for FDA meetings, and prepare and submit routine regulatory documents such as Annual Reports/DSURs, Investigator Packages, and SUSARs.

You will represent Regulatory Affairs on cross-functional teams, working closely with other team members to support corporate and departmental objectives. Key aspects of this role include planning and managing submissions, maintaining meticulous attention to detail in written correspondence and regulatory files, and collaborating with diverse internal and external stakeholders.

Responsibilities

• Plan and oversee IND-related activities, including Annual Reports, Orphan Drug Reports, DSURs, and other CTA activities for ongoing studies or study start-ups.
• Manage the planning, compilation, quality control, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.
• Prepare routine IND and CTA amendments, such as Annual Reports/DSURs, Investigator Packages, and SUSARs.
• Independently manage vendors/CROs for planning and tracking source documents to ensure high-quality, timely delivery of IND, IND amendments, CTA, and EU-CTR submissions.
• Support the implementation of regulatory strategy for assigned projects and programs across all stages of development (IND through NDA/BLA approval and commercialization).
• Collaborate with submission authors and reviewers to ensure complete source document planning and on-schedule approval of high-quality documents, adhering to regulatory guidelines, styles, and processes.
• Represent Regulatory Affairs and provide regulatory expertise to cross-functional teams on specified projects and topics.
• Independently manage submission trackers for multiple products.
• Maintain logs of IND and CTA submissions and correspondence with the FDA or other regulatory agencies.
• Prepare templates or shells for specific submissions based on company standards.
• Compile and prepare effective presentations for external and internal audiences as needed.
• Perform other duties as assigned.

Qualifications

• BS degree required; advanced degree (PharmD, PhD, Master’s) preferred.
• Strong scientific or research background, with a focus in pharmacy, chemistry, or biology, preferred (or relevant experience).
• Minimum of 8 years’ experience in regulatory affairs or a related function in drug/biologic development.
• Experience managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format is a plus.
• Understanding of U.S. and ex-U.S. (including international) regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.

Skills

• Advanced skills in Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
• High attention to detail and accuracy.
• High level of motivation and proactiveness to engage with both in-person and remote team members.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to work independently with minimal supervision or direction.
• Comfortable in a fast-paced, small-company environment with minimal direction and able to adjust workload based on changing priorities.