Senior Regulatory Affairs Specialist

USAntibiotics, LLC
United States, Tennessee, Bristol
Apr 30, 2025
Overview USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We're always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence. Responsible for support of regulatory affairs activities under direction of department management. Activities may include but are not limited to: Compilation/review of Annual Reports, original applications, amendments, supplements and product labeling. Assessment of proposed changes to manufacturing facilities, processes, and/or controlled documents. ROLES & RESPONSIBILITIES: Product support activities: Compilation and review of FDA Submissions (e.g., NDA/ANDA Filings, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with change control review/approval and management. Additional responsibilities as assigned by management. QUALIFICATIONS: Bachelor's degree in a scientific area of interest required (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing). Minimum of two years experience plus a Regulatory Affairs Certification or four years of direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated environment. KNOWLEDGE, SKILLS AND ABILITIES: Competency with regulations, policies, and procedures relating to company and regulatory guidelines Ability to multitask and manage multiple projects with interdisciplinary teams Effective communication (verbal and written) with external and internal customers, vendors, and regulators. Participation and familiarity with post-approval submissions to FDA, and with ad/promo materials to FDA as well as hands-on experience reviewing and approving labeling and marketing regulatory materials. Strong planning and organizational / project / workload management skills. Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects. Strong ability to work independently as well as in a team environment. Ability to drive projects to completion with minimal guidance. Solid interpersonal (verbal and written) communication skills at all levels. Formal project management skills are a plus. Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry is a plus. Regulatory publication experience using eCTD software is a plus. Experience in the use of PC-based word processing software, databases, spreadsheets, and Adobe Acrobat,including database management and support. SAP experience a plus. Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema is preferred. Experience with metrics management and reporting. Proven negotiation skills with internal and external stakeholders. EEO Statement USAntibiotics is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender, gender identity and expression, national origin, age, disability or protected veteran status. We celebrate diversity and are committed to creating an inclusive environment for all of our associates.