The Director, Regulatory Affairs will head the Regulatory function at MaxCyte. The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements. Utilizes knowledge of regulatory requirements and regulations to maintain current regulatory filings; interpret, plan, and communicate requirements; and maintain regulatory compliance to ensure governmental approvals are obtained.
Job Responsibilities:
Researches and interprets regulations, guidance's, and precedents to support interdepartmental project teams in developing strategies, policies, and procedures that ensure regulatory compliance with global regulatory agencies
Maintains and updates existing Master Files in various countries
Creates and implements effective regulatory strategies to deliver an efficient and robust development plan
Partners closely with Legal, Quality, Manufacturing, Engineering, Business Development, Commercial, and other areas of the organization to ensure timely and strategic submissions
Supports projects and product teams to prioritize and identify issues that may increase regulatory risks and propose strategies to address such risks. Suggests solutions for regulatory concerns regarding country specific regulations, guidelines, and precedents
Develops regulatory processes and procedures and implements best practices
Effectively plans, organizes, and participates in meetings with regulatory agencies
Leads and or participates in communications and meetings with various global Regulatory Authorities to ensure the review and acceptance of master file and development plans, the timely resolution of issues, and the approval of client marketing applications
Identifies and diminishes quality and regulatory risks in collaboration with other colleagues and stakeholders
Interfaces with consultants, auditors, regulatory advisors
Assess impact of changing regulations on submission and product development strategies and updates internal/external stakeholders in a timely manner
Complies with all applicable policies regarding health, safety, and the environment
Requirements:
BS/BA in science or engineering field with at least 8-10 years of leadership experience and at least 8 years of relevant regulatory experience within biologics drug development, ideally in cell and gene therapy. Experience in life sciences tools and enabling technologies preferred
Advanced degrees (MA/MS/Ph.D.) preferred
Solid understanding of global regulatory and legal liability issues. Demonstrated knowledge of regulatory standards and processes, predominantly in FDA-regulated environments
Hands-on experience in global DMF filings and compliance
Proven track record of success in problem solving and developing risk-based solutions
Strong verbal and written communications skills and the ability to convey complex regulatory requirements in a straightforward and practical manner
Displays good business acumen
Proven track record of success in problem solving and developing risk-based solutions
Experience working on cross-functional teams to driving change and successful implementation
Understands relevant industry trends and regulatory developments and changes
Strong written and oral communication skills
Builds and cultivates strong relationships
The compensation package for this role includes a base salary range of $210,000 - $229,000 (depending on experience), annual bonus, and equity. MaxCyte also offers a comprehensive benefits package including health, dental, vision, life, and disability insurance and generous time off.
MaxCyte is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
