Associate Director / Director, CMC Regulatory Affairs
Viridian Therapeutics
Boulder, Colorado
director
cmc
cmc regulatory affairs
regulatory
regulatory
cmc
team
lead
product development
communication
regulatory requirements
coordinate
patients
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November 27, 2022
Viridian Therapeutics
Boulder, Colorado
- Job Type Full-time Description At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today s therapies.
- Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases.
- We strive for data-driven decisions, strategic risk-taking, and efficient use of time and funds to best position our ideas for success.
- We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.
- Viridian Therapeutics currently seeks an Associate Director / Director, CMC Regulatory Affairs to lead the CMC regulatory function, provide guidance to broader CMC functions, and drive CMC regulatory activities that support the company s product development strategies.
- This individual will ensure all applicable CMC regulatory requirements are considered and appropriately incorporated into clinical and commercial product development plans.
- The incumbent will work collaboratively with senior leadership and key stakeholders to develop CMC regulatory objectives for one or more programs, lead the preparation and filing of regulatory CMC submissions, and manage the preparation for interactions with Health Authorities.
- Responsibilities: Lead the development of CMC regulatory strategy for assigned clinical-stage programs, identifying key issues, necessary remediation activities, and opportunities for acceleration throughout project/product life cycle.
- Assess and communicate CMC regulatory requirements to ensure all global development activities comply with applicable regulations and guidelines in each jurisdiction.
- Facilitate the preparation for CMC-focused meetings with FDA, EMA, or national competent authorities, and participate in or lead the interactions with these agencies.
- Serve as the regulatory representative at internal CMC team meetings.
- Work within a cross-functional team to coordinate and prepare high quality, timely correspondence and CMC regulatory submissions (e.g., original INDs, CMC amendments, annual reports, Agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development.
- Provide regulatory review and input on core product development documentation (e.g., stability protocols and reports, method or process validation protocols and reports, specifications, technical assessments, etc
- Coordinate with appropriate team members and stakeholders to resolve outstanding CMC regulatory issues.
- Work directly with external contractors and collaborators, managing the chain of communication and updating regulatory project plans as necessary for accuracy and success.
- Coordinate and conduct CMC regulatory project review sessions, determine frequency and content of status reports, and deliver routine updates including presentations to Regulatory department, Product Development Team Lead, or executive management, as required.
- Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities.
- Provide input on project related budgets and ensure projects operate within capital and expense budget guidelines.
- Requirements Suitable candidates will have an undergraduate or advanced degree in a scientific discipline with a minimum 8+ years of experience working in Regulatory Affairs and Quality in the pharmaceutical industry.
- Clear record of success as a Regulatory Affairs and Quality Manager in a biopharma environment.
- Experience managing complex regulatory projects that span multiple years, systems and regulatory standards.
- Thorough knowledge of the drug development process.
- Must possess and demonstrate an excellent understanding of FDA and international regulatory requirements and guidelines.
- Detailed familiarity with the content and structure of regulatory submissions, including the eCTD.Adept at prioritizing and completing tasks in a high-pressure environment.
- Proven leadership within a cross-functional project team.
- Demonstrated ability to anticipate and address regulatory issues related to drug development.
- Exceptional oral and written communication skills including excellent technical writing abilities.
- Solid foundation of scientific knowledge to facilitate understanding of all regulatory issues.
- Occasional domestic and international travel required (typically less than 25%).
- Viridian offers a flexible work environment.
- This position can have a hybrid work model based out of our Waltham, MA location.
- Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.
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