Associate Manager, Regulatory Affairs

About the Role: The Regulatory Affairs Associate Manager manages, evaluates, and completes regulatory projects consistent with company goals. You will be responsible for the timely planning and coordination of regulatory submissions, provide guidance to cross-functional teams on regulatory strategy and tactics, and assist in the authoring and preparation of annual reporting while managing the regulatory archive.

What You'll Do

• With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical and non-clinical.
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
• Manage the preparation, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
• Ensure regulatory submissions are maintained in compliance with regulatory requirements, and support the preparation of meeting requests and briefing documents.
• Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc.
• Develop and maintain current regulatory knowledge, advise management of significant developments, and work with external regulatory consultants/CRO's as required.

What You Bring

• BA / BS in Health Science (preferred).
• 4+ years of experience in the pharmaceutical industry.
• Proficiency in computer skills: Word, Excel, PowerPoint.
• Global competencies: Entrepreneurial mindset, analytical thinking/data analysis, results-oriented, and the ability to communicate with clarity.
• Ability to foster teamwork and act inclusively within cross-functional project teams.

Benefits

• Salary Range: $103,000.00 - $138,000.00 annually.
• Opportunity to work remotely in a fast-paced environment fighting cancer.