Ultragenyx

Manager, Global Regulatory Strategy

Ultragenyx

full-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $132,400 - $163,600 per year

About the role

  • Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met.
  • Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development program.
  • Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks.
  • Develop and/or review regulatory documents to ensure that all submissions are of high quality.
  • Provide critical review of documents (SOPs, protocols, and reports) related to clinical, nonclinical or manufacturing, as necessary.
  • Interface with functional areas (Nonclinical, Clinical, Commercial) to identify and obtain information required for regulatory submissions.
  • Prepare/coordinate/file/manage IND/CTAs, annual reports, and information amendments in multiple countries for multiple protocols.
  • Prepare/coordinate/file/manage regulatory applications (IND/CTA, NDA/BLA/MAA).
  • Interface with global regulatory authorities and consultants.
  • Coordinate, prepare for and conduct Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages.
  • Maintain knowledge of current global rules, regulations, and guidances governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area.

Requirements

  • BA/BS degree in life sciences or experience in drug development that allows for sufficient knowledge in this area.
  • Strong scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
  • Prior experience with product development in a project management role with relevance to early phase non-clinical and clinical drug development.
  • Excellent attention to detail with solid coordinating, task planning and time management skills.
  • Outstanding verbal, written and interpersonal communication skills.
  • Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
  • Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies.
  • Thorough understanding of global drug development regulations and guidelines.
  • Proven ability to successfully manage major submissions and critical projects to deadlines.
  • Proven ability to successfully interact with regulatory authorities.
Benefits
  • Generous vacation time and public holidays observed by the company
  • Volunteer days
  • Long term incentive and Employee stock purchase plans or equivalent offerings
  • Employee wellbeing benefits
  • Fitness reimbursement
  • Tuition sponsoring
  • Professional development plans
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory submissionsregulatory strategyregulatory documentsIND/CTA managementNDA/BLA/MAA applicationsproject managementrisk mitigation strategiesclinical drug developmentnonclinical drug developmentattention to detail
Soft Skills
communication skillsleadershipnegotiationproblem-solvingstrategic thinkingtime managementtask planningindependenceteam collaborationinterpersonal skills
Certifications
BA/BS degree in life sciences