Job Description

Regulatory Affairs Manager

The 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.

Responsibilities

• Advise clients on current FDA regulations, policies, and guidance's applicable to CDER and CBER.
• Provide regulatory strategy and guidance on FDA requirements for meetings and applications.
• Serve as the US agent or Regulatory Contact on behalf of the Sponsor for FDA interactions.
• Lead the regulatory process for FDA Meetings, ODDs, DMFs, INDs and any regulatory submissions for product life cycle management.
• Provide leadership to Subject Matter Experts (SMEs) in multidisciplinary teams and manage day-to-day operations of project tasks/activities to ensure deliverables are met in a timely manner within budget.
• In collaboration with the SMEs, identify critical regulatory issues that may impact the development process and provide strategies to address them.
• Provide document formatting, preparation and quality assessment of regulatory documents to ensure compliance with FDA guidelines.
• Collaborate in multidisciplinary proposal development and following up with outstanding proposals.
• Engagement and managing the use of affiliates, when appropriate.
• Sharing 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.
• Provide project coverage for team members, when necessary.
• Support business development activities and build client relationships to generate referrals.
• Other duties as assigned.
• Develop experience in the following areas: General understanding of marketing applications (BLAs, NDAs, ANDAs, Biosimilars).

Requirements

• Bachelor's degree or advanced degree in life science, biology, regulatory affairs or healthcare field.
• 5+ years of regulatory experience in the biotech, pharmaceutical or drug development industry.
• 2 or more years of supporting cross-functional project teams.
• Strong project management and organizational skills.
• Working knowledge of FDA regulatory guidelines and ICH regulations related to drugs and biologics.
• Intermediate experience of eCTD modules, regulations, submissions, and the drug development processes.
• Experience with multiple electronic software/platforms (such as Vantagepoint, Starting Point 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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