Manager, Regulatory Affairs

August 30

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Ultragenyx

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Rare mission. Fearless team. Incredible possibilities.

rare disease • ultra-rare disease

501 - 1000

Description

• The Manager, Regulatory Affairs, coordinates regulatory deliverables and interactions for select programs. • Assist in developing regional regulatory strategies. • Represent Regulatory in appropriate sub team meetings, serving as the point of contact for assigned products. • Provide regulatory guidance and input throughout product clinical development. • Lead cross functional teams in Regulatory Filings (e.g. INDs, BLAs, CTAs, MAAs). • Drive submissions on select programs. • Review clinical documentation for GCP and Agency compliance. • Manage and direct contractors/vendors as needed.

Requirements

• BA/BS in a scientific field of study or BA/BS in another field of study and 4-6 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry • Strong knowledge and experience in interpretation of regulations and guidelines related to drug development • In depth understanding and application of industry standards and international regulations and guidelines. • Experience in communicating regulatory strategy, submission documents and plans both internally and externally • The desire and ability to work in a fast-paced, start-up environment • Strong collaboration, team work, organizational skills at attention to detail • Excellent written and verbal communication skills

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