Senior Associate, Regulatory Affairs - US

General Description:

The Senior Associate plans, tracks, and executes U.S. regulatory submissions to the FDA for investigational and commercial products. The position supports IND, NDA, and BLA filings and serves as a key operational liaison between U.S. Regulatory Strategy, Regulatory Publishing, and cross‑functional stakeholders to ensure submissions are delivered accurately, on time, and in compliance with FDA requirements.

The role assumes end‑to‑end execution responsibility for assigned U.S. submissions and requires strong communication skills, exceptional organizational discipline, and a proactive, hands‑on mindset, as well as the ability to operate as a flexible, collaborative team player who is open to learning and adapting in a fast‑paced, deadline‑driven environment.

This role requires prior Regulatory Affairs experience, including hands‑on support of U.S. IND preparation and working knowledge of NDA submissions and related amendments or supplements; it is not an entry‑level position .

Essential Functions of the Job:

• Coordinate preparation and execution of US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements) in compliance with FDA regulations and guidance.

• Draft regulatory submission documents (e.g., IND components) as required.

• Review regulatory documentation to ensure accuracy, consistency, and completeness, and supports the effective execution of regulatory submissions to health authorities.

• Serve as the primary execution lead and cross‑functional coordinator for assigned U.S. regulatory submissions, ensuring clarity of roles, timelines, and deliverables.

• Partner with U.S. Regulatory Strategists to translate regulatory plans into executable submission timelines and deliverable strategies.

• Collaborate with Clinical, CMC, Safety, Nonclinical, Medical Writing, Labeling, and to collect and organize FDA submission-ready documents.

• Perform Quality control (QC) checks to ensure accuracy, consistency, and compliance with eCTD technical specifications and FDA requirements.

• Liaise with Regulatory Publishing to support on‑time, first‑cycle‑quality FDA submissions.

• Maintain IND, NDA, and BLA submission archives ensuring version control, document integrity, and inspection readiness.

• Request FDA application numbers via the CDER NextGen Portal and support FDA correspondence tracking.

• Utilize regulatory tracking tools (e.g., Veeva Vault RIM, submission trackers) to monitor milestones, deliverables, and risks.

• Monitor FDA guidance updates and contribute to continuous improvement of US submission processes.

Supervisory Responsibilities:

• None

Computer Skills:

• Familiarity with regulatory systems such as Veeva Vault BRIM and document management tools.

• Proficiency in Microsoft Office (Word, Excel, PowerPoint)

• Ability to manage submission timelines, trackers, and Master Document Lists.

• Proficiency in Microsoft Office.

Education & Experience Required:

• BA/BS degree, preferably in a scientific or health‑related discipline with 2+ years OR 5+ year of Regulatory Affairs experience, including hands‑on support of U.S. IND preparation (required)

Other Qualifications:

• 3+ years of direct experience preparing and executing FDA submissions (IND, NDA, BLA) and lifecycle management activities.

• Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional.

• Understanding of FDA structure and working knowledge of FDA and ICH regulatory guidance and regulations is desirable.

• Assist regulatory affairs team/strategist in supporting strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.

• Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.

• Demonstrates sound judgment and practical business awareness in supporting regulatory activities and execution decisions.

• Demonstrates ability to function as a trusted cross‑functional partner in a matrixed regulatory environment.

• The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.

• Hands‑on, execution‑driven mindset with accountability for deliverables and outcomes.

• Clear written and verbal communication with cross-functional teams.

• Ability to work independently and collaboratively under tight FDA-driven timelines.

• Strong organizational and documentation skills

• Ability to manage multiple US submissions and priorities simultaneously

Travel : N/A

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.