Sr Manager, Regulatory Affairs - Virology

Role Summary

You will typically act as the Regional Regulatory Lead on the assigned products, compounds, indications or projects in Virology. With guidance, you will define the regulatory strategy, plans and objectives for the assigned products or projects. You will typically lead the Regulatory Submissions Teams associated with assigned products or projects and represent Global TA Regulatory to cross-functional sub-teams. You may serve as a Gilead contact to / for regulatory authorities.

You will oversee and manage the work of less experienced colleagues supporting your work. You will coach and advise less experienced colleagues in completing their work and developing their regulatory capabilities. You will typically be assigned products, compounds, indications or projects of increasing complexity. You will also typically play a more active role in process improvements and other special projects that can carry significant value to multiple Regulatory Affairs activities and teams.

Position will be filled in either Foster City, CA or Parsippany, NJ.

• Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.
• Participates on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers).
• With guidance, defines the regulatory strategy for one or more Gilead products or projects.
• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans.
• Leads the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s).
• Leads cross-functional teams in the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
• Provides input to the content of the original label and label updates.
• Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets.
• Critically reviews documents for submission to regulatory authorities.
• Initiates or otherwise contributes to process improvements and/or other special projects within Regulatory Affairs.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

• Required:
  
  Doctorate and 2+ years of relevant experience OR
• Required:
  
  Master’s and 6+ years of relevant experience OR
• Required:
  
  Bachelor’s and 8+ years of relevant experience
• Preferred:
  Significant regulatory, quality, compliance or related experience supporting medicinal products.
• Preferred:
  Significant regulatory experience in the biopharma industry.
• Preferred:
  Experience setting the regulatory strategy and leading regulatory submissions and other activities for a medicinal product.
• Preferred:
  Experience successfully leading departmental and cross-functional teams without authority.
• Preferred:
  Experience authoring and implementing processes.
• Preferred:
  Experience working with one or more Gilead therapeutic areas and varying stages of drug development.
• Preferred:
  Demonstrated ability to be a fast learner and to be flexible and adaptable to change.
• Preferred:
  Demonstrates advanced knowledge of regulatory requirements and the role of regulatory affairs, including ICH standards and market requirements.
• Preferred:
  In-depth knowledge of relevant health authorities and demonstrated success in HA interactions.
• Preferred:
  Able to represent Gilead to regulatory authorities during standard or routine negotiations.
• Preferred:
  Strong analytical thinking, attention to detail, communication and writing skills, and project management skills.
• Preferred:
  Ability to lead and influence programs, projects and initiatives; strong interpersonal skills; ability to operate in a matrix environment.
• Preferred:
  When needed, ability to travel.