Our Cell and Gene Therapy Biotech client is seeking a Director, Regulatory Affairs who will support the CDMO 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.

• 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/or 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/or support client submissions to regulatory agencies, including but not limited to strategies for technology transfer, process/method validation, and stability.
• Participate in due diligence activities for potential licensing opportunities and/or 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/or regional SOPs as required in order to verify compliance to regulatory expectations and standards.
• Supervisory Responsibility
• This is an individual contributor role in a heavily matrixed environment.

REQUIREMENTS

• BA/BS Life Sciences is required. MS or PhD in chemistry or biology and/or Regulatory Affairs is strongly preferred.
• Regulatory Affairs Certification preferred
• 7-10 years experience 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
• CMC Regulatory experience in cell therapies is required
• Ability to work independently with minimal supervision is required
• Proven interpersonal skills with face to face and remote teams
• 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
• Phone conferences outside of normal working hours is occasionally required in order to interact with global counterparts.
• Travel less than 25% is required.

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey.

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