/

Associate Director CMC/Complex Biologics

Cambridge, MA or Remote USA

We are seeking an experienced and driven CMC Regulatory professional with experience in Cell and Gene Therapy products.


Position: Associate Director - CMC, Complex Biologics

Location: Remote work for site based in Cambridge, MA

 

Responsibilities:

(1) Chemistry, Manufacturing and Controls (CMC)

  • Participate as team member or lead consultant in a number of the company’s projects, in an international environment.
  • Participate in the definition and implementation of CMC regulatory strategies for development and registration of innovative drugs, mostly cell and gene therapies.
  • Participate in due diligence/gap analysis.
  • Provide advice on operational and technical CMC subjects (manufacturing, analytical development, validation, specification setting, stability, etc.).
  • Identify CMC regulatory risks and potential based on global regulations and guidances.
  • Remain current with CMC EU and US trends and requirements.
  • Direct interactions with global regulatory authorities; lead meetings and support CMC regulatory activities.
  • Manage, coach and develop consultants by transmitting knowledge of regulatory CMC.
  • Serve as in-house CMC regulatory expert for internal and external projects.
  • Participate in providing VCLS visibility by presenting at conferences/webinars and contribute to the writing articles.
  • Contribute to the development of the “CMC & Quality” activity, both by growing the existing projects, by generating and taking charge of new projects. This includes working closely with Business Development and Account Management and meeting with prospect clients, coordinating the writing of new proposals for collaboration, and developing an efficient working relationship with the clients.
  • Communicate with US-based companies seeking advice from VCLS, in order to promptly initiate new projects.

 

(2) Regulatory Sciences:

  • Write, review and assemble high quality regulatory submissions, including but not limited to: Quality Modules of Marketing Authorization Applications (MAA/BLA); Investigational New Drug (IND/IMPD); and Pre-IND briefing documents, Agency interactions.
  • Ensure compliance with regulations and applicable guidelines.

 

(3) Project Management:

  • As a project team member/leader/advisor, execute the prescribed activities for domestic/international client projects.
  • Adhere, monitor, prioritize and supervise projects’ strategy, timelines, and milestones and communicate them to the project team members.

 


The ideal candidate will possess the following qualifications (only candidates that meet the following criteria will be considered):

 

Experience

Knowledge of CMC Regulatory Sciences as demonstrated through a combination of work experience and academic background.

  • Prior professional CMC (cell or gene therapy) experience in biotech for multiple years.
  • Prior experience with regulatory submissions and interactions with the FDA and other regulatory agencies for a few years.
  • Direct interactions with the Health Authorities.
  • Experience in a consulting environment is a plus.
  • BS/BA in Regulatory Affairs or Life Sciences. MS and Ph.D. are a plus.

 

Personal attributes and skills

  • Strong attention-to-detail, organization/multitasking, project management (research, planning, scheduling, documentation, project control), teamwork, and communication skills.
  • Consulting skills: influencing, advising, facilitating, diplomacy, critical thinking, adaptable, and presenting.
  • Problem-solving abilities and a self-starter.
  • Professional and courteous work demeanor. A relationship builder with colleagues, clients, and regulatory authorities.
  • Ability to work under deadlines to meet project timelines, including the ability to modify work schedule (occasional varied and extended days/hours) when needed.
  • Computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) and Adobe Acrobat.
  • Maintains company values (People, Innovation, Passion, Excellence) and demands the highest standards of conduct from self and others.

 

Additional Information

  • Equal Opportunity Employer
  • All resumes are held in confidence
  • Must be eligible to work in the US