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Senior Director/Director of Regulatory Affairs

Verge Genomics

Verge Genomics

Legal, Sales & Business Development
Posted on Saturday, October 21, 2023
Who We Are
Technology has transformed almost every single aspect of our lives. Yet, it still takes 12 years to develop a drug. Today thousands of diseases affecting hundreds of millions of people have no effective treatment. Accelerating the pace of bringing effective, new medicines to patients is one of the greatest opportunities for humanity. Our mission is to develop better drugs, faster using technology. We have built an end-to-end technology-driven drug discovery platform centered around one of the field’s largest human genomics databases in neuroscience. We use aspects of machine learning to map the complex causes of disease and turn those insights into promising drug candidates on our internal biology and chemistry platforms.
We are developing drugs to treat some of the biggest medical challenges today: ALS, Parkinson’s Disease, and Alzheimer’s Disease. Our first drug entered the clinic in October 2022 as a new treatment for ALS and was discovered entirely from our platform. We have raised $134M from top tier investors (e.g. BlackRock, Eli Lilly, Merck, Section 32, Threshold Ventures, Y Combinator, etc) and in 2021 we announced a $706M deal with Eli Lilly. We are a team of data scientists, neuroscientists, and drug developers united around an audacious vision: to build the next Genentech of the digital age.
Who You Are
The Senior Director/Director of Regulatory Affairs will support all regulatory activities for Verge Clinical Development Programs. The Senior Director/Director will lead regulatory strategy and collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications in alignment with the regulatory strategy. The Director will successfully support Clinical Development projects in an innovative and results-oriented environment to help advance the development of new medicines for the patients who can’t wait. The company is based in the San Francisco area and the position can be on site or remote from anywhere in the United States.

What You'll Do...

  • Develop clinical and CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA).
  • Identify regulatory opportunities as well as risks across regions and implement mitigation plans.
  • Provide guidance for regulatory CMC aspects of product development projects.
  • Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines.
  • Lead Regulatory discussions and interactions with health authorities to facilitate planning, review, and approval of submissions.
  • Establish regulatory processes, procedures, and SOPs at Verge to build the appropriate foundation for GCP and CMC components of regulatory submissions.
  • Resource access to submission templates and submission vendors.
  • Provides CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls.
  • Provide interpretation of regulatory guidance documents and regulations.
  • Advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs.

You'll Have...

  • Director Level Qualifications
  • BA/BS degree in a scientific/engineering discipline
  • 6-8+ years of experience in the pharmaceutical industry
  • Knowledge of current US and EU regulations and GCP and cGMP
  • Experience with CTD format and content regulatory filings
  • Senior Director Level Qualifications
  • BS, MS or Doctoral degree in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field is desirable.
  • 8-10+ years of experience in regulatory in the pharmaceutical/biotech industry
  • Knowledge of current US and EU regulations and GCP and cGMP
  • Experience in Regulatory CMC is desirable

Additional Considerations...

  • A key skill is exceptional written and oral communication skills to effectively collaborate across functions, especially clinical, quality and safety. To ensure compliance with regulatory guidelines across regions/Countries, the Director/Senior Director of Regulatory Affairs must work closely with clinical, quality, safety, and manufacturing teams.
  • A key goal is to support Regulatory Compliance and set up the company foundation for successful future regulatory submissions in coordination with the Quality function.
  • The Director/Senior Director will be asked to set up a unified platform for Regulatory Information Management to properly store and track and update information and connect business processes and people while providing real-time data and insights into the organization.
Compensation & Benefits at Verge Genomics:
Our target starting salary for successful US-based applicants for this role is $158,000 to $240,000. To determine starting pay, we consider multiple job-related factors including a candidate’s skills, education and experience, the level at which they are actually hired, market demand, business needs, and internal parity. We may also adjust this range in the future based on market data.
This role is eligible for participation in our Annual Performance Bonus Plan (based on company targets by role level and annual company performance) and all employees are offered Equity, subject to the terms of those plans and associated policies.
In addition, Verge Genomics also provides our employees:
*Excellent medical, dental, and vision coverage
*401(k) plan with employer matching for contributions
*Disability insurance, Life insurance, Dependant Care FSA and Healthcare FSA
*Unlimited paid time off
*Paid parental leave
*Access to free onsite fitness center
*Free snacks and lunch for employees who work onsite
*WFH stipend for employees who work remotely
Help us revolutionize the way drugs are discovered & developed:
The startup nature of Verge Genomics provides multiple growth opportunities into other areas of the company. As one of the early employees at Verge, your work will have a direct impact on the foundation of a groundbreaking new drug development model.