Regulatory Affairs Manager Jobs

Manager, Regulatory Affairs

Responsibilities:

• Responsible for review, submission and tracking of PADERs, PSURs, PBRERs, DSURs and authoring as needed
• Coordinate the update, review, approval, submission and tracking of promotional review materials
• Represent Regulatory Affairs during regulatory authority inspections and audits
• Manage the review, approval, and maintenance of Company Core Data Sheets (CCDS) and USPI
• Complete assigned tasks in an efficient and timely manner.
• Share information that may be useful to all staff regarding trends or notable events.
• Manage the authoring, review, submissions and tracking of NDAs, IND/Amendments, Health Authority Meeting packages, Marketing Authorization Applications, Annual Reports
• Prepare and maintain SOPs (Standard Operating Procedures) in support of key regulatory processes.
• Maintain current awareness of evolving Health Authority regulations and interpretations, advisory letters, and policy issues affecting the pharmaceutical industry and determine relevance to the business
• Represent Regulatory function for new systems and process implementation and improvement.
• Serve as the regulatory liaison with Health Authorities where needed
• Work collaboratively with cross-functional colleagues in Pharmacovigilance, Quality, Legal, Medical Affairs, and Commercial to ensure practices are consistent with regulatory guidelines, company policies, and in support of business objectives
• Ensure compliance oversight of regulatory services vendor(s)
• Support a “culture of quality”
• Serve as the subject matter expert responsible for end-to-end regulatory lifecycle management of our products, including but not limited to regulatory submissions and tracking, Health Authority communications, labeling management, and promotional review

Requirements:

• Direct experience planning, authoring, reviewing, submitting, and/or tracking NDAs, IND amendments, PBRER/PSURs, DSURs, Health Authority meeting packages, Marketing Authorization Applications
• Must have exceptional problem solving, strategic and analytical thinking skills.
• Experience interacting directly with Health Authorities via verbal and written communication
• Prior vendor management experience preferred
• BS degree in pharmacy or other related scientific field, advanced degree preferred
• Strong project management skills and ability to manage multiple priorities simultaneously
• Primary work is remote.
• Understanding of Health Authority regulations relating to:
• Minimum 8 years relevant industry experience in a pharma/biotech setting.
• Experience with regulatory information management systems, label management solutions, submissions and tracking solutions/gateway platforms.
• Must be proficient with Microsoft Office applications (Word, Excel, PowerPoint, SharePoint)
• Must have strong scientific skills and a deep understanding of the subject of Drug regulation and required submissions.
• Must have exceptional verbal and written (i.e., technical writing) communication.

1. NDAs, Annual Reports, INDs/Amendments, PADERs, PSURs/PBRERs, DSURs, Post-marketing commitments, NDA transfers
2. Advertising and promotion of prescription products, including experience interacting with Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB)