Senior Director, Regulatory Affairs

Company: NeuroTech X
Location: San Francisco
Posted on: March 19, 2023

Job Description:

Senior Director, Regulatory Affairs
Regulatory - South San Francisco, CA, United States (Remote) - Full time
At Alector, our mission is to develop therapies that empower the immune system to combat neurodegenerationand cancer. Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partnerswho share in our commitment to bettering the lives of patients.
The Senior Director of Regulatory Affairs will develop and lead regulatory strategies while supervising regulatory colleagues responsible for the execution of outputs critical to the company's business goals.
During your first year, your responsibilities and goals will include:

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• Develop global regulatory strategies for innovative programs, in both early and mid-stage development, that enable efficient and timely development and licensing of innovative drug products in the field of neurodegenerative diseases.
  
• Manage and mentor regulatory professionals who are assigned to pipeline projects and responsible for key product development outputs and associated submissions.
  
• Represent Regulatory Affairs on project team(s). Serving as the single point of contact for regulatory issues for the assigned project(s). Liaising with Regulatory sub-functions to coordinate work in support of Program Lifecycle Team goals.
  
• Ensure the development and execution of robust regulatory strategies for assigned program(s), including input on development plans, Target Product Profile (TPP), landscape reviews, regulatory risk assessments, resource planning, and associated regulatory submissions/health authority interactions (e.g. clinical trial applications, marketing applications) in collaboration with multi-disciplinary development teams and/or Alector Regulatory Affairs management
  
• Serve as the Regulatory Lead and drive the global regulatory strategy. Lead health authority interactions, including pre-meeting preparation.
  
  We'd love to hear from you if you have:
  
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  • 10+ years of pharmaceutical industry experience in R&D or related product development functions with at least 6 years working in Regulatory Affairs.
    
  • Excellent communication skills. This position is based in the San Francisco Bay Area.
    
  • Advanced degree is preferred (MS/PhD/PharmD).
    
  • Experience in CNS drug development is desirable, along with experience working with rare diseases.
    
  • Direct experience with the FDA Office of Neuroscience is preferred (Division of Psychiatry and/or Division of Neurology I/II).
    
    Knowledge, Skills, and Other Experience
    
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    • Ability to work well and foster collaboration within cross-functional teams and collaborations.
      
    • Ability to influence decision-making without authority and contribute to decision-making during both the design and execution of clinical development programs.
      
    • Prior mentorship and training experience.
      
    • Demonstrated regulatory leadership on projects and in interactions with regulatory agencies.
      
    • Proven knowledge and understanding of sophisticated, evolving scientific and regulatory topics and ability to apply to novel situations.
      
    • Excellent verbal communication and writing skills.
      
    • Develops collaborative relationships to facilitate the accomplishment of work goals.
      
    • Outstanding ethics and integrity.
      
    • Phenomenal teammate valuing transparency and collaboration.
      
      #LI-BL1
      #LI-Hybrid
      Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.
      Alector was named on Fortune's ""top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022.
      Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits.Come join us!
      At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other's assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.
      Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief.
      We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
      Please to apply.
      

Keywords: NeuroTech X, San Francisco , Senior Director, Regulatory Affairs, Executive , San Francisco, California