Regulatory Affairs Manager

Responsibilities

• Advises clients on current FDA regulations, policies, and guidance’s applicable to CDER and CBER.
• Provides regulatory strategy and guidance on FDA requirements for meetings and applications.
• Serves as the US agent or Regulatory Contact on behalf of the Sponsor for FDA interactions.
• Leads the regulatory process for FDA Meetings, ODDs, DMFs, INDs and any regulatory submissions for product life cycle management.
• Provides leadership to Subject Matter Experts (SMEs) in multidisciplinary teams and manages day-to-day operations of project tasks/activities to ensure deliverables are met in a timely manner within budget.
• In collaboration with the SMEs, identifies critical regulatory issues that may impact the development process and provides strategies to address them.
• Provides document formatting, preparation and quality assessment of regulatory documents to ensure compliance with FDA guidelines.
• Collaborates in multidisciplinary proposal development and follows up with outstanding proposals.
• Engages and manages the use of affiliates, when appropriate.
• Shares regulatory intelligence and experience with regulatory affairs.
• Participates in continued education to maintain current regulatory knowledge through active participation in conferences and training.
• Provides mentoring and training opportunities for colleagues.
• Participates in developing and maintaining internal processes and SOPs.
• Provides project coverage for team members, when necessary.
• Supports business development activities and builds client relationships to generate referrals.

Qualifications

• 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.