Responsibilities: Uses knowledge of Food & Drug Administration (FDA) and International Council for Harmonization (ICH) regulations and guidelines to review documents for the development of the Company's novel drug products.
Maintains the Investigational New Drug (IND) lifecycle, including drafting all administrative forms and cover letters, publishing of eCTD documents for all electronic transmissions with the health authorities. Maintains tracking of regulatory and quality commitments with submission material documentation. Manages the progress of all regulatory submissions including drafting all administrative FDA forms and cover letters, final approval of all electronic submissions with FDA, and record keeping of all submission materials.
Assists in drafting responses to FDA comments and interrogatories. Prepares IND/Master File submissions, material, amendments, annuals, and safety reports. Reviews Institutional Review Board (IRB) submission documentation for initial approval.
Point of contact between the Company and eCTD vendors for regulatory submissions. Prepares and publishes final eCTD documents for regulatory agencies. Develops Standard Operating Procedures (SOPs) to manage regulatory submissions and obligations.
Participates in the creation, review, and finalization of company-wide SOPs and ensures ongoing compliance. Supports health authority inspections of both clinical and manufacturing sites. May serve as an escort for health authority inspectors.
Participates in inspection close-out meetings and supports written responses to inspection observations. Supports the generation of regulatory, clinical, non-clinical, and CMC documentation to health authorities.
Reviews clinical protocols, informed consents, investigator brochures, pharmacy manuals, serious adverse event reports, and clinical start-up documents ensuring submission to regulatory authorities.
Reviews quality and manufacturing changes needed to support change control. Provides support and regulatory strategy for implemented changes. Serves as a Regulatory Affairs representative on assigned project teams to provide direction and address regulatory compliance issues. . REQUIRED QUALIFICATIONS Bachelor's or master's degree in biology, chemistry, microbiology, biochemistry, or related 8-10 years of related industry experience, preferably FDA regulated 2+ years of regulatory affairs experience Knowledge of FDA, EMA, cGCP, cGMP, cGLP regulations, and ICH guidelines Biopharmaceutical drug development Regulatory submission management Health agency communication Microsoft Office Word, Excel, PowerPoint, Adobe, Outlook Common Technical Document (CTD) and Electronic CTD format and publishing BENEFICIAL QUALIFICATIONS Regulatory submission requirements for drug development including Target Product Profile (TPP) Medical Device/combination product experience Clinical trial management Regulatory Affairs Certification (RAC) Candidates should be in the local Pittsburgh and surrounding areas and able to easily interview and relocate to the Pittsburgh area. #LI-LC1 EEO Employer Apex is an Equal Employment Opportunity/Affirmative Action Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . VEVRAA Federal Contractor We request Priority Protected Veteran & Disabled Referrals fo
Apex Systems, Inc