Director of Regulatory Affairs (FDA)

Director Us Regulatory Affairs

The Director US Regulatory Affairs supports the contract development and manufacturing of client cell therapy products for the US market. This individual collaborates cross-functionally to support client projects, including support for submissions, coordinating pre-approval inspections, and managing compliant licensing for all facilities supplying the US market. This individual also creates and maintains systems by which regulatory documentation is created, approved, submitted, and maintained.

Essential Functions and Responsibilities:

• Coordinate projects and activities across regulatory support functions in Europe and Japan in order to formalize and harmonize regulatory processes, procedures, and infrastructure across the network.
• Responsible to maintain up to date knowledge of regulatory requirements for cell therapy products in both clinical and commercial phases and communicate changes in requirements through the organization.
• Plan, coordinate, author, and review any submissions to FDA to ensure company requirements and relevant FDA requirements are met.
• Liaise with Project Managers and participate on global client project teams to properly plan for and support client submissions to regulatory agencies, including but not limited to strategies for technology transfer, process and method validation, and stability.
• Participate in due diligence activities for potential licensing opportunities and acquisitions.
• Manage GMP licensing for North America sites and supports global sites in obtaining appropriate licenses to market product in the US.
• Critically review complex reports and change control documentation for regulatory and risk mitigation strategies.
• Ensure compliance to Pharmacopeia through monitoring of changes and careful implementation at sites.
• Develop relationships with Health Authorities through external engagement via professional organizations, conferences, and committees.
• Coordinate across Global Quality and across Sites to support inspection coordination in order to obtain the appropriate GMP certifications for each site.
• Work with the Global Head of Quality and Regulatory to plan for the long-term strategy and development of the Regulatory Affairs Department, including the development of client service offerings.
• Provide regulatory training to site level associates as a Subject Matter Expert Partner with the Global Quality Systems organization in order to maintain the accuracy of the Global Quality Manual and Standards.
• Provide review of Global Quality Manual and Standards, as well as global and regional SOPs as required in order to verify compliance to regulatory expectations and standards.

Competencies:

• Excellent collaboration, agility, and adaptability
• Strong leadership skills including influencing ability, driving results, commitment and execution, working in teams and a matrix environment
• Demonstrated history of strong decision making
• Well organized, adept at planning and working effectively within cross-disciplinary teams
• Excellent oral, written, and verbal communication skills are required
• Strong computer skills are required

Qualifications:

• BA/BS in the Life Sciences is required.
• MS or PhD in chemistry or biology and/or Regulatory Affairs is strongly preferred.
• Minimum 7-10 years in Regulatory Affairs in an FDA Regulated Industry is required.
• Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required.
• Knowledge of European and Japanese Health Authority requirements is strongly preferred.
• Chemistry and Manufacturing Control (CMC) Regulatory experience is a must.
• Regulatory Affairs Certification preferred.
• Ability to work independently with minimal supervision is required.
• Proven interpersonal skills with face to face and remote teams.
• Minimum Required Training Incumbent will be expected to complete all assigned GxP and Compliance related training in accordance with assigned due dates.