Senior Director, Regulatory Affairs

Job Type

Full-time

Description

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

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.

Salary Description

210k - $229k depending on experience

Salary : $210,000 - $229,000