The Regulatory Affairs Associate is responsible for regulatory submissions and maintaining submission information in a proper Regulatory Affairs systems. The incumbent work cross-functional with internal departments and external resources on source documents and Regulatory related issues, ensuring those are in compliance with FDA regulations and company SOPs. The incumbent is also responsible for preparation of labeling and artwork, eCTD compilation and submission for ANDAs and NDAs registration and maintenance.

Responsibilities: Regulatory Affairs Associate:

• Interacts effectively with cross functional teams to coordinate/facilitate procurement of documentation required for regulatory submissions, ensuring that departmental timelines are met.
• Create documents in accordance with eCTD specifications.
• Prepare and submit regulatory submissions using eCTD software, publishing tool to FDA.
• Author, compile and review technical documents (CMC) for accuracy and acceptability in New Applications (i.e. ANDAs or NDAs), Amendments, Supplements, PADER, Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA.
• Coordinate preparation of SPL for drug products and update labelling, annual drug listing.
• Reviews and signs-off on change control documentation. Assesses changes and their impact on the business based on an understanding of product, regulatory guidelines and applicable federal laws.
• Update and maintain the internal database as needed.
• Comply with FDA guidelines/Company Policies of Data Integrity.
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.

Technical Competencies: Regulatory Affairs Associate:

• Knowledge/Experience of Chemistry, Manufacturing and Control sections of original Abbreviated New Drug Applications (ANDA), amendments, supplements, and annual reports.
• Knowledge/Experience of Chemistry, Manufacturing and Control sections of New Drug Applications (NDA), amendments, supplements, and annual reports.
• Review of Drug Master Files (DMF), amendments, supplements and annual reports.
• Strong knowledge of United States of Pharmacopoeia.
• Expert knowledge of Title 21 of Code of Federal Regulations, various US FDA guidance and ICH guidelines
• Comply with FDA guidelines/Company Policies of Data Integrity.
• Proficient with use of technologies (e.g. Adobe Acrobat, ESG, XML, SPL) and eCTD publishing tools
• Strong working experience in ANDA, NDA eCTD submissions.
• Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidance.
• Must demonstrate strong leadership skills
• Possess strong attention to details.
• Excellent multi-tasking skills and ability to manage multiple competing projects while meeting project timelines
• Good written and oral communication skills
• Experience in statistical analysis, process capability reviews with software
• Ability to act independently
• Excellent interpersonal, verbal and written communication skills

Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws.