Senior Regulatory Affairs Specialist

Jackson Healthcare•Bristol, TN

73d

About The Position

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. Job Description Summary Responsible for supporting all aspects of regulatory compliance, submission preparation, and product lifecycle management under the direction of the department management. This role also provides cross-functional support to ensure compliance with pharmacovigilance (drug safety) reporting requirements in accordance with FDA and global regulatory standards. Activities may include but are not limited to: • Compilation/review of original applications (INDs, NDAs, ANDAs), amendments, supplements, annual reports and product labeling in accordance with FDA and ICH guidelines. • Assessment of regulatory impact of proposed changes to manufacturing facilities and processes. raw material sources, packaging components, and/or controlled documents.

Requirements

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.
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.
Experience in the use of PC-based word processing software, databases, spreadsheets, and Adobe Acrobat, including database management and support.
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.

Nice To Haves

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.
SAP experience a plus.

Responsibilities

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.
Compile, review, and format regulatory submissions including Annual Reports, original applications (INDs, NDAs, ANDAs), amendments, supplements, and product labeling in accordance with FDA and ICH guidelines.
Ensure regulatory submissions are accurate, complete, and submitted in electronic Common Technical Document (eCTD) format.
Support interactions with FDA and other regulatory agencies, including drafting responses to deficiency letters and managing agency correspondence.
Participate in regulatory intelligence monitoring and maintain awareness of evolving requirements impacting marketed and pipeline products.
Coordinate with internal and external partners to ensure timely submission of Individual Case Safety Reports (ICSRs), Periodic Adverse Drug Experience Reports (PADERs), and Field Alert Reports (FARs).

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