Regulatory Affairs SpecialistUSAntibiotics, 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 supporting the preparation, publishing, validation and submission of regulatory documents to the FDA. Will be responsible for product and submission lifecycle management under the direction of department Director. 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. Interface with cross-functional teams to author, review, and compile high-quality regulatory dossiers (such as CTD Modules 2 and 3) to secure and maintain product approvals from health authorities such as FDA.Manage controlled regulatory documents within document management systems.
Roles and Responsibilities:
Author, review and compile FDA Submissions (e.g., NDA/ANDA Filings, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages and Periodic Adverse Drug Experience Reports (PADERs)) as agreed upon with change control review/approval and management and in accordance with FDA and ICH guidelines Publish electronic submissions using eCTD publishing software ensuring accuracy and completeness of submissions. Build and validate eCTD sequences and perform technical validation check prior to submission. Resolve any publishing validation errors and submission deficiencies. Assessment of regulatory impact of proposed changes to manufacturing facilities and processes, raw material sources, packaging components, and/or controlled documents. Support interactions with FDA and other regulatory agencies. Additional responsibilities as assigned by management.
Knowledge, Skills and Abilities:
Competency with regulations, policies, and procedures relating to company and regulatory guidelines. Understanding of ICH guidelines, FDA/EMA regulations, and cGMP requirements related to drug substance and drug product manufacturing.
Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema is preferred. Regulatory publication experience using eCTD software is preferred.
Ability to multitask and manage multiple projects with interdisciplinary teams.
Effective communication (verbal and written) with external and internal customers, vendors, and regulators. Exceptional technical writing and document-authoring capabilities.
Solid interpersonal (verbal and written) communication skills at all levels.
Knowledge in working with post-approval CMC submissions to FDA.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.
Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry is a plus.
Experience with FDA ESG, SPL submissions/drug listing is preferred.
Experience in the use of PC-based word processing software, databases, spreadsheets, and Adobe Acrobat, including database management and support. SAP experience a plus.
Qualifications:
Bachelor's degree in a scientific area of interest required (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing).Minimum of one years' experience plus a Regulatory Affairs Certification or two years of direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated environment.
Travel Requirements & Working Conditions:
May require occasional travel as needed.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of office work.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or inspect; write; type; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and smell.
The employee may infrequently lift or move up to 30 pounds.
Job requires close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
EEO Statement:
We are an Equal Opportunity Employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under the law.
