Senior Manager, Regulatory Affairs

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

📋 Description

• Oversee and coordinate regulatory activities for designated projects encompassing clinical, non-clinical, and CMC technical domains.

• Aid in crafting and executing strategies aimed at achieving the earliest possible approvals or clearances for regulatory submissions.

• Manage the preparation, writing, assembly, review, and timely submission of regulatory documents for product investigation and registration in both the US and international markets.

• Ensure that regulatory submissions adhere to all relevant compliance standards.

• Assist in the preparation of meeting requests and briefing materials.

• Supervise the preparation, review, and submission of INDs and their amendments, BLAs/NDAs and their supplements, annual reports, safety reports, and other submission elements.

• Collaborate with cross-functional project teams and provide regulatory insights.

• Continuously develop and update regulatory knowledge and inform management about significant industry developments.

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

• Work with external regulatory consultants and CROs as necessary.

⛳️ Requirements

• A minimum of 7 years of relevant experience.

• Bachelor's degree (BA/BS).

• Proven experience and knowledge in the preparation of INDs (mandatory).

• Familiarity with NDAs (preferred).

• Experience in preparing supporting amendments and supplements related to manufacturing, nonclinical, and clinical aspects.

• Proficient in CTD/eCTD formats.

• Experience with document publishing using Adobe Acrobat Professional.

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

• Knowledge of FDA's structure and function.

• Awareness of regulatory requirements for other regions (preferred).

• Working knowledge of GMP, GLP, and GCP regulations.

• Comprehension of the pharmaceutical product lifecycle.

• Exceptional oral and written communication abilities.

• Strong planning capabilities.

• Detail-oriented and self-motivated, with comfort in handling broad responsibilities within an entrepreneurial, fast-paced, small company environment.

🏝️ Benefits

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

• Qualification for an incentive compensation plan for Commercial roles.

• Opportunity for discretionary equity awards.

• Option to voluntarily participate in the Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account (FSA/HSA).

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness programs.