Hybrid Associate Director, Regulatory Affairs – EMEA

at Ultragenyx

• Job title: Associate Director, Regulatory Affairs – EMEA
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Basel, Switzerland

About the role

• Associate Director, Regulatory Affairs managing EMEA regulatory strategies for products at Ultragenyx Pharmaceutical. Focusing on regulatory objectives aligned with corporate goals and product development efforts.

Responsibilities

• Provides strategic and technical input on regulatory requirements to development teams
• Participates in regulatory strategy development and executes the strategy
• Provides input on development plans
• Reviews regulatory documents
• Coordinates sections of major applications (IND, NDA, BLA, MAA etc)
• Assists in preparing label text
• Tracks PMCs/PMRs
• May be Primary liaison with Regulatory Agencies
• Manages planning, preparation and execution of agency meetings
• Leads Agency response processes
• Manage the coordination between global and local regulatory partners

Requirements

• Minimum BS/BA in life sciences
• Advanced degree preferred
• At least 8 years regulatory experience
• Sound knowledge of global regulatory framework, drug development and post approval requirements
• Specific knowledge and experience of the regulatory requirements in the GCC region is required
• Travel requirements less than 10%
• Fluent in English, Arabic is a plus
• This position can be located either in UK, Switzerland or Dubai (Applicants must be in possession of a valid work permit for the location)

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