Associate Director Regulatory Affairs CMC - Biologics

Company: Galderma Research & Development, LLC
Location: Boston
Posted on: November 12, 2024

Job Description:

Associate Director Regulatory Affairs CMC - Biologics
Location: Boston, MA (Hybrid 3/days week in office)
Description
The Associate Director RA CMC -Biologics will report to the Head of Regulatory Affairs CMC. The Associate Director Regulatory Affairs CMC- Biologics will be responsible for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (focused on biologics and combination products). Develop CMC regulatory strategies and establish data requirements worldwide and prepares CMC sections for investigational and commercial products (CTIS, IND, MAA, NDA). Participates in new CMC activities from initial project plan to registration.
Key Responsibilities

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• Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include CMC information.
  
• Writes/assembles CMC sections of regulatory submissions including clinical trial and variations/supplements as well as registration submission worldwide ensuring alignment with regulations, guidelines, policies and procedures.
  
• Manage answers to questions from the Authorities in a timely and effective manner to ensure early approval.
  
• Participate in interactions with Competent Authorities if needed.
  
• Develop and maintain project plans and schedules for CMC submissions.
  
• Evaluate proposed manufacturing changes for global impact and provide regulatory strategies that support change implementation.
  
• Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them.
  
• Provide guidance on ICH, FDA and EU CMC guidelines.
  
• Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory objectives.
  
• Represent the Regulatory Affairs CMC function on assigned cross-functional project teams.
  
• Responsible for management of the service provider contracted to support a project, if appropriate.
  
• Ensures all CMC dossiers and relevant regulatory information are stored in the appropriate database according to company's guideline.
  
  Key Qualifications
  
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  • BSc, MSc in a scientific discipline or Pharmacist required.
    
  • 10+ years in CMC Regulatory Affairs for biologics.
    
  • Global Experience Highly Preferred.
    
  • Experience with biologics and/or combination products.
    
  • Experience in interactions with Health Authorities (FDA/EMA).
    
  • Focused on effective delivery of objectives, even when working with tight deadlines.
    
  • Planning, organizing and time management skills.
    
  • Problem solving and analytical skills.
    
  • Ability to identify opportunities/major issues and to communicate impact.
    
  • Demonstrated ability to deal with rapid change.
    
  • Effective verbal and written communication skills in a cross-functional environment and with external partners.
    
  • Fluent in English.
    
    What we offer in return
    You will be working for an organization that embraces diversity & inclusion and believes we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.
    Next Steps
    
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    • If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
      
    • The next step is a virtual conversation with the hiring manager.
      
    • The final step is a panel conversation with the extended team.
      
      Our people make a difference
      At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
      Employer's Rights:
      This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
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Keywords: Galderma Research & Development, LLC, Portland , Associate Director Regulatory Affairs CMC - Biologics, Executive , Boston, Maine