Senior Regulatory Affairs Manager

Company: Regulatory Affairs Professionals Society
Location: Alexandria
Posted on: November 1, 2024

Job Description:

Senior Regulatory Affairs Manager Level of Position: Senior Regulatory Affairs Manager Reports to: Business Unit Lead, Regulatory Affairs The Senior Regulatory Affairs Manager is the primary point of contact and responsible for facilitating regulatory oversight and management in all phases of drug development. Managing multidisciplinary teams and client interactions to ensure key regulatory milestones and timelines are met. A critical component for senior level roles is the capability to provide clients with strategic regulatory advice along with training and mentoring opportunities for other team members. The Senior Regulatory Affairs Manager will be responsible for overseeing regulatory compliance, assisting with regulatory submissions, and providing ongoing maintenance support for FDA applications. The role involves collaborating with cross-functional teams and staying current on regulations and industry trends. Key Responsibilities:

• Advise clients on current FDA regulations, policies, and guidance applicable to CDER and CBER.
• Provide strategic regulatory advice and guidance on FDA requirements for meetings and applications.
• Lead the regulatory process for FDA Meetings, ODDs, DMFs, INDs, marketing applications (BLAs, NDAs, ANDAs, Biosimilars) and any regulatory submissions for product life cycle management.
• Provide leadership and regulatory oversight on multidisciplinary projects.
• In collaboration with the SMEs, identify critical regulatory issues that may impact the development process and provide strategies to address them.
• Serve as the US agent or Regulatory Contact on behalf of the Sponsor for FDA interactions.
• Provide document formatting, preparation, and quality assessment of regulatory documents to ensure compliance with FDA guidelines.
• Proposal development review and support for large multidisciplinary RFPs.
• Share regulatory intelligence and experience with regulatory affairs.
• Participate in continued education to maintain current regulatory knowledge through active participation in conferences and training.
• Provide mentoring and training opportunities for colleagues.
• Participate in developing and maintaining internal processes and SOPs.
• Support business development activities and build client relationships to generate referrals. Qualifications & Competencies:
  • Bachelor's degree or advanced degree in life science, biology, regulatory affairs or healthcare field.
  • 7 - 10 years of regulatory experience in the biotech, pharmaceutical or drug development industry.
  • Demonstrated experience leading and managing multidisciplinary teams through complex regulatory preparation and FDA interactions.
  • Expert knowledge of FDA regulatory guidelines and ICH regulations related to drugs and biologics.
  • Experience with late-stage development, marketing and post-approval activities required, specifically with pre-BLA and BLA strategies.
  • Familiarity with CDER NextGen Portal, CDER Direct, SPLs, Establishment Registrations, Lot Distribution Report requirements, etc. are strongly preferred.
  • Expert level of understanding of eCTD modules, regulations, submissions, and product development processes.
  • Advanced project management and leadership skills.
  • Experience with multiple electronic software/platforms (such as Vantagepoint, StartingPoint templates (or similar regulatory templates), Smartsheet, MS Office suite or other project management programs).
  • Advanced Word formatting skills required.
  • Demonstrated ability to handle multiple ongoing projects in various stages of development.
  • Ability to drive projects to completion by proactively coordinating the efforts of external and internal partners.
  • Ability to work effectively both independently and in a team environment.
  • Excellent time management skills with the ability to prioritize responsibilities and multitask.
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