Senior Manager, Regulatory Affairs

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

📋 Description

• Oversee, assess, and finalize regulatory initiatives aligned with the organization's objectives.

• Strategically plan and coordinate regulatory submissions while offering insights on regulatory strategies and tactics.

• Serve as the Regulatory Affairs representative on interdisciplinary project teams.

• Provide regulatory insights to project teams.

• Lead the authorship and preparation of annual reports.

• Manage regulatory submissions across clinical, non-clinical, and CMC technical domains.

• Formulate and execute strategies aimed at securing early approvals or clearances for regulatory submissions.

• Prepare, draft, compile, review, and submit regulatory dossiers for product investigation and registration both domestically and internationally.

• Ensure regulatory submissions adhere to compliance with regulatory standards.

• Draft, review, and submit meeting requests and briefing materials.

• Prepare, review, and submit INDs, amendments, BLAs/NDAs, supplements, annual reports, and safety documentation.

• Engage in project teams, contributing regulatory expertise.

• Stay informed on current regulatory trends and advise management on significant changes.

• Ensure adherence to departmental standards and maintain the regulatory archive.

• Collaborate with external regulatory consultants and CROs as necessary.

⛳️ Requirements

• A minimum of 7 years of relevant experience with a BA/BS degree is required.

• Proven experience and knowledge in preparing INDs is essential.

• Experience in preparing NDAs is preferred.

• Familiarity with supportive amendments and supplements related to manufacturing, nonclinical, and clinical sectors.

• Proficient in CTD/eCTD.

• Experience in publishing documents using Adobe Acrobat Professional.

• Solid understanding of FDA and ICH regulatory guidelines and regulations.

• Awareness of the FDA's structure and functions.

• Knowledge or experience with regulatory stipulations in other regions is a plus.

• Working familiarity with GMP, GLP, and GCP regulations.

• Comprehension of the pharmaceutical product lifecycle.

• Exceptional oral and written communication abilities.

• Outstanding planning capabilities.

• Detail-oriented and self-motivated.

• Comfortable handling extensive responsibilities in a dynamic, fast-paced small company setting.

🏝️ Benefits

• Eligibility for an annual bonus plan for Non-Commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account.

• Life insurance coverage.

• Paid Time Off.

• Wellness program.