Project Manager, Regulatory Affairs

Employer
Retrophin
Location
San Diego, California
Posted
Oct 10, 2020
Ref
R-100071
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
At Retrophin, our mission is to identify, develop and deliver life-changing therapies to people living with rare disease. Giving patients a chance, providing hope, is what drives us.

Retrophin recognizes that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of patients. Our work is rewarding, professionally and personally because we are making a difference and we are passionate about what we do.

We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast paced environment and share in our mission to help others. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland.

Position Summary:

The Project Manager, Regulatory Affairs is responsible for facilitating regulatory submissions and regulatory planning for R&D and commercial programs. This position works with the Regulatory Affairs Strategy leaders to create regulatory project timelines and dashboards, schedule internal meetings, track regulatory commitments, manage external vendor contracts and track spending against budget. In addition, this position will participate in program specific regulatory sub-teams and regulatory project planning.

Essential Functions:

  • Apply program management expertise to support regulatory project management and operations for multiple programs.
  • Facilitate and manage Regulatory Sub-team meetings and other regulatory meetings including scheduling, establishing agendas with Regulatory Leads, prepare/distribute minutes and ensure action item follow-up.
  • Create, maintain and manage regulatory project timelines and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies.
  • Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities.
  • Document project milestones/deliverables and report progress against team, department and corporate goals in dashboard format.
  • Facilitate and manage short and long-term regulatory project planning activities including Regulatory Plan development and execution.
  • Analyze internal Regulatory Affairs and Project Management processes and assist in the identification of opportunities for improvement.
  • Manage deliverables for the department and cross-functional project team members and ensure deliverables are completed on time for the Regulatory Leads.
  • Maintain archive to store project deliverables, meeting minutes and other pertinent documents.
  • Schedule regular check in meetings with Retrophin Program Management Team to leverage existing tools, align with program and regulatory project goals and reporting and ensure alignment with program timeline development.


Qualifications:

  • Bachelor's degree or higher degree, MS, Pharm D, PhD preferred in related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.
  • 5+ years of Project Management experience in Biotech or Pharmaceutical industry including some regulatory specific project management experience preferred.
  • Expertise with timeline development and management software required (e.g., MS Project).
  • Strong professional experience in a similar role within the pharmaceutical industry.
  • Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional team work environment.
  • Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
  • Successful record of creating and managing complex project plans, timelines, budgets and critical paths.
  • Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
  • Ability to travel less than 5% domestic and internationally.


Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer