Director, Regulatory Affairs Job at MaxCyte, Inc, Rockville, MD

ZHUrV0g5bE5jS3duQ3hYYUtJM3BHaUxiOWc9PQ==
  • MaxCyte, Inc
  • Rockville, MD

Job Description

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


  • 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.

Salary Description


$210k - $229k depending on experience MaxCyte, Inc

Job Tags

Full time,

Similar Jobs

Nava Software Solutions LLC

Data Analyst - Remote Job at Nava Software Solutions LLC

 ...business process SMEs a phone call away. Requirements: Mid-level and more data analytics than PM Parts/Industry experience From the client: I'd add B2B experience this is a plus, not a hard requirement. Project Management experience + data... 

HealthTrust Workforce Solutions HCA

Travel Nurse RN - Rehabilitation - $1,877 per week Job at HealthTrust Workforce Solutions HCA

 ...900-0730), rotating weekends and must float to Med/Surg if needed. Must have AZ License, BLS and 2 years + Rehab experience. Cerner preferred, 3/12's(1900-0730), rotating weekends and must float to Med/Surg if needed. rxCS882906 About HealthTrust Workforce Solutions... 

Work In Biotech

Laboratory Technician Job at Work In Biotech

 ...visit , and follow us on LinkedIn and Twitter .As an emerging, global biotech with locations in Boston, Massachusetts, Basel, Switzerland, London, England and Oslo, Norway, we take advantage of diverse scientific depth and insights which makes ARTBIO a unique place... 

Joanna Rubin

Remote Wedding Planner Job at Joanna Rubin

 ...We are seeking a passionate and detail-oriented Wedding Planner to join our team. As a Wedding Specialist, you will play a vital role in helping couples plan and coordinate their dream weddings. You will work closely with clients to ensure that every aspect of their special... 

JEVS Human Services

JEVS Internship Opportunities - Spring Semester Job at JEVS Human Services

 ...? Let us know what you're interested in and we'll try to match you with an opportunity! All JEVS internships are hybrid and part-time. How does this program work? We take your interests and match them with our programs? So what work will I be doing? We...