Regulatory Affairs Manager

Job description

The Senior Manager of Regulatory Affairs 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: Senior Manager of Regulatory Affairs:

• Responsible for regulatory submissions and maintaining submission information in a proper Regulatory Affairs systems.

• The incumbent works cross-functionally 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.

Key Duties: Senior Manager of Regulatory Affairs:

Regulatory Submissions:

• Work cross-functionally with internal departments and external resources (e.g., CROs, CMOs) to ensure that source documents are received in a timely manner for submissions.

• Prepares original ANDAs and NDAs, amendments ensuring these are in compliance with applicable FDA regulations.

• Performs documents formatting and publishing to ensure that submission documents adhere to FDA eCTD requirements and company SOPs.

• Has responsibility for archiving of all original submissions in a secure system and maintains and keeps an up-to-date record of all correspondence with FDA.

Labeling and Artwork:

• Work cross-functionally with internal departments and external resources to ensure that labeling and artwork are received, reviewed and approved in a timely manner for submissions.

• Prepares contents of labeling for new registration and/or revised labeling of drug products in accordance with RLD and applicable FDA regulations (e.g., 21 CFR 201 and 208).

• Proofreads, reviews and approves labeling printer proofs to ensure accuracy of contents, completeness and integrity.

• Monitors RLD labeling updates and initiates change requests, if necessary, for labeling of all new registration and marketed products in accordance with RLD.

Technical Competencies: Senior Manager of Regulatory Affairs

• 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.

Job Type: Full-time

Salary: $100,000.00 - $180,000.00 per year

Benefits:

• 401(k)

• 401(k) matching

• Dental insurance

• Employee assistance program

• Health insurance

• Life insurance

• Paid time off

• Retirement plan

• Vision insurance

Schedule:

• 8 hour shift

• Monday to Friday