Director, Regulatory Affairs

5 days ago

Rockville MD United States MaxCyte Inc 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




Compensation details: 00 Yearly Salary



PIad9-2728

  • Regulatory Affairs Director

    2 weeks ago

    Rockville, Maryland, United States GlaxoSmithKline Full time

    Job Title: Regulatory Affairs DirectorAt GlaxoSmithKline, we are committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are seeking a highly skilled Regulatory Affairs Director to join our team and play a key role in ensuring the development and execution of our regulatory strategy.Key...

  • Regulatory Affairs Director

    3 weeks ago

    Rockville, Maryland, United States MaxCyte Inc Full time

    Job Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies to ensure...

  • Global Regulatory Affairs Director

    3 weeks ago

    Rockville, Maryland, United States GlaxoSmithKline Full time

    Job Overview: We are seeking an Associate Director, Global Regulatory Affairs to join our team at GlaxoSmithKline. **Job Summary:** As an Associate Director, Global Regulatory Affairs, you will be responsible for developing regulatory strategies for assigned assets and ensuring compliance with internal processes and regulatory requirements. **Key...

  • Regulatory Affairs Director

    3 weeks ago

    Rockville, Maryland, United States MaxCyte Inc Full time

    Job Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies to ensure...

  • Director of Global Regulatory Affairs

    2 weeks ago

    Rockville, Maryland, United States GSK Full time

    Director, Global Regulatory Affairs - RNA VaccinesLead Regulatory Strategy for RNA VaccinesGSK is seeking a highly skilled Director, Global Regulatory Affairs to lead the regulatory strategy for our RNA vaccines portfolio. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory plans to ensure compliance...

  • Regulatory Affairs Director

    2 weeks ago

    Rockville, Maryland, United States MaxCyte Inc Full time

    Job Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs, safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies and plans to ensure...

  • Regulatory Affairs Director

    1 week ago

    Rockville, Maryland, United States MaxCyte Full time

    Job Title: Director, Regulatory AffairsMaxCyte is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs while ensuring safety, quality, and regulatory compliance.Key Responsibilities:Develop and implement regulatory compliance strategies to maintain...

  • Regulatory Affairs Director

    2 weeks ago

    Rockville, Maryland, United States MaxCyte Inc Full time

    Job Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced and skilled Director, Regulatory Affairs to lead the Regulatory function and develop and implement regulatory compliance and strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and...

  • Regulatory Affairs Director

    7 days ago

    Rockville, Maryland, United States MaxCyte Inc Full time

    Job Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies to ensure...

  • Regulatory Affairs Director

    2 weeks ago

    Rockville, Maryland, United States MaxCyte Inc Full time

    Job Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs, safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance and strategies to ensure...

  • Director, Regulatory Affairs

    3 weeks ago

    Rockville, United States MaxCyte Inc Full time

    Job DescriptionJob DescriptionDescription: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...

  • Global Regulatory Affairs Director

    2 weeks ago

    Rockville, Maryland, United States GSK Full time

    Job Title: Global Regulatory Affairs DirectorAt GSK, we are committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are seeking a highly skilled Global Regulatory Affairs Director to join our team and play a key role in ensuring the development and execution of our regulatory...

  • Director of Regulatory Affairs

    2 weeks ago

    , MA, United States Proclinical Staffing Full time

    Director, Global Regulatory Affairs, Development StrategyProclinical Staffing is seeking a seasoned professional to fill the role of Director, Global Regulatory Affairs, Development Strategy for a leading global biotechnology company.Key Responsibilities:Develop and implement a comprehensive US regulatory development strategy to ensure successful...

  • Director of Lifecycle Regulatory Affairs

    4 weeks ago

    Orlando, FL, United States VirtualVocations Full time

    A company is looking for a Director of Regulatory Affairs, Lifecycle. Key Responsibilities Oversee the Lifecycle Regulatory team and manage personnel activities Develop and execute global regulatory strategies for commercialized products Ensure compliance with regulatory Conditions of Approval and oversee advertising and promotion reviews Required...

  • Director of Regulatory Affairs CMC

    2 weeks ago

    , MA, United States GSK Full time

    Job Title: Director of Regulatory Affairs CMCWe are seeking a highly skilled and experienced Director of Regulatory Affairs CMC to join our team at GSK. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring the timely and successful submission of CMC regulatory documents to support the development,...

  • Associate Regulatory Affairs Director

    4 weeks ago

    Gaithersburg, MD, United States AstraZeneca GmbH Full time

    EMPLOYER: AstraZeneca Pharmaceuticals LPTITLE: Associate Regulatory Affairs DirectorLOCATION: Gaithersburg, MDHOURS: Full-Time; Mon-Fri (40 hours/week)DUTIES: Lead the end-to-end planning, coordination, and execution of assigned deliverables. Contribute to regulatory submission strategy, identifying submission risks and opportunities. Lead regulatory...

  • Associate Director Regulatory Affairs CMC

    2 weeks ago

    Rockville, Maryland, United States Arcellx, Inc. Full time

    About Arcellx, Inc.Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.Job SummaryWe are seeking an...

  • Associate Director Regulatory Affairs CMC

    7 days ago

    Rockville, Maryland, United States Arcellx, Inc. Full time

    About Arcellx, Inc.Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.Our TeamOur team members are...

  • Head of Regulatory Affairs

    2 weeks ago

    Rockville, United States Proclinical Staffing Full time

    Head of Regulatory Affairs - Permanent - Fully remote Proclinical is seeking a Head of Regulatory Affairs to lead strategic regulatory decisions for an innovative biotech portfolio. Primary Responsibilities:This role will be responsible for leading the strategic regulatory decisions for their cutting-edge portfolio. As a core member of the leadership team,...

  • Head of Regulatory Affairs

    2 weeks ago

    Rockville, United States Proclinical Staffing Full time

    Head of Regulatory Affairs - Permanent - Fully remote Proclinical is seeking a Head of Regulatory Affairs to lead strategic regulatory decisions for an innovative biotech portfolio. Primary Responsibilities:This role will be responsible for leading the strategic regulatory decisions for their cutting-edge portfolio. As a core member of the leadership team,...