IT Governance, Risk and Compliance Analyst managing compliance initiatives like NIST and ISO standards in technology and security operations.
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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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