Senior Associate, US Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee, assess, and execute regulatory projects in alignment with company objectives

• Organize and supervise regulatory activities pertaining to assigned projects across technical fields, including clinical, non-clinical, and CMC

• Assist in formulating and executing strategies aimed at achieving the earliest possible approvals/clearances for regulatory submissions

• Manage the preparation, writing, compilation, review, and timely submission of regulatory dossiers

• Ensure that regulatory submissions comply with all regulatory requirements

• Support and coordinate the preparation of meeting requests and briefing documents

• Oversee the preparation, review, and submission of all elements of regulatory submissions

• Contribute as a member of project teams by providing expertise on regulatory issues

• Develop and sustain up-to-date regulatory knowledge while advising management on significant developments

• Prepare and maintain a regulatory archive

• Collaborate with external regulatory consultants and CROs as needed

⛳️ Requirements

• A BA/BS in Health Science is preferred, along with a minimum of 2+ years of experience in the pharmaceutical industry

• Required experience and knowledge in the preparation of INDs and desirable knowledge of NDAs

• Familiarity with CTD/eCTD

• Experience in publishing documents using Adobe Acrobat Professional

• Solid understanding of FDA and ICH regulatory guidelines and regulations

• Comprehension of the FDA's structure and functions

• Knowledge and experience with regulatory requirements for other regions is also a plus

• Familiarity with GMP, GLP, and GCP regulations

• Exceptional oral and written communication skills

• The ideal candidate should be detail-oriented, a self-starter, and capable of managing broad responsibilities within a fast-paced, entrepreneurial, small company environment

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness