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Full-timeDescriptionThe 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
Salary Description$210k - $229k depending on experience
