Job Description

Overview:

Support regulatory activities under the direction of department management. Responsibilities may include, but are not limited to:

• Compilation and review of Annual Reports, original applications, amendments, supplements, and product labeling.
• Assessment of proposed changes to manufacturing facilities, processes, and controlled documents.

Roles & Responsibilities:

• Compile and review FDA submissions, including NDA/ANDA filings, amendments, supplements, annual reports, DMF updates, and labeling packages.
• Participate in change control review and approval processes.
• Ensure compliance with regulatory policies, procedures, and industry guidelines.
• Support post-approval FDA submissions and review advertising/promotional materials for regulatory compliance.
• Assist with regulatory assessments related to product manufacturing changes.
• Perform additional responsibilities as assigned by management.

Qualifications:

Education:

• Bachelor’s degree in a scientific field (e.g., Chemistry, Microbiology/Biology, Pharmacy, Premed, Nursing).

Experience:

• Minimum of two years of regulatory affairs experience plus a Regulatory Affairs Certification OR
• Minimum of four years of direct pharmaceutical industry experience in a cGMP and/or FDA-regulated environment.
• Solid Oral Dosage

Knowledge, Skills, & Abilities:

• Strong understanding of FDA regulations, policies, and procedures.
• Ability to manage multiple projects across interdisciplinary teams.
• Effective verbal and written communication skills for interactions with internal/external stakeholders, vendors, and regulatory agencies.
• Experience with post-approval FDA submissions, advertising/promotional material reviews, and labeling/marketing regulatory compliance.
• Strong planning, organizational, and project management skills.
• Ability to work under deadlines, adapt to shifting priorities, and drive projects to completion with minimal guidance.
• Experience with electronic regulatory submissions, including eCTD software and FDA/ICH Common Technical Document (CTD) XML-compliant schema (preferred).
• Proficiency in Microsoft Office Suite, Adobe Acrobat, and database management; SAP experience is a plus.
• Experience with metrics management and reporting.
• Regulatory publication experience (preferred).

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