Senior Regulatory Affairs Associate

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

📋 Description

• Support the US Regulatory Lead (USRL) in various US regulatory activities, including the development and submission of Investigational New Drug (IND) applications, Biologic License Applications (BLAs), and New Drug Applications (NDAs), as well as preparations for advisory committee meetings.

• Collaborate with the USRL to provide and maintain documentation for IND/BLA/NDA, including annual reports and amendments.

• Create and manage product regulatory history documents in the regulatory document management system while ensuring proper archiving of all regulatory documents and communications with agencies.

• Review the US component of the Global Regulatory Strategic Plan (GRSP) and contribute to operational deliverables; conduct regulatory research to assist in developing content for the GRSP plan as assigned by the Global or US Regulatory Lead.

• Actively promote regulatory compliance and ensure that submissions to the US FDA meet all requirements.

• Assist the Global or US Regulatory Lead by preparing supporting documentation for regulatory deliverables, such as regulatory landscapes or research for regulatory strategies and target product labels.

• Coordinate the collection of functional documents needed for regulatory applications.

• Participate in Global Regulatory Teams (GRT) and aid Global Regulatory Leads in managing GRT meetings, including setting agendas and taking minutes.

• Help the USRL manage the process of responding to inquiries from the FDA.

• Oversee the Quality Check (QC) of regulatory documentation, such as briefing packages.

• Take primary authorship of routine regulatory correspondence, including annual reports.

• Prepare regulatory packages and cross-reference letters to support investigator-initiated studies.

• Complete regulatory forms necessary for agency communications, such as FDA form 1571.

• Support initiatives aimed at process improvement, development of standards, and metrics.

• Assist in the development and maintenance of templates.

• Respond to specific requests and communicate relevant issues to the GRT.

• Aid in the development and execution of GRT objectives.

⛳️ Requirements

• Master's degree.

• Alternatively, a Bachelor's degree with 2 years of regulatory or pharmaceutical experience.

• Or an Associate's degree with 6 years of regulatory or pharmaceutical experience.

• Or a High school diploma / GED with 8 years of regulatory or pharmaceutical experience.

🏝️ Benefits

• A comprehensive benefits package for employees, which includes a Retirement and Savings Plan with substantial company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.