Associate Director, Regulatory Affairs, EMEA

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Ultragenyx is seeking an experienced and highly motivated Associate Director, Regulatory Affairs (Clinical/Nonclinical Strategy), EMEA who is a team player and enjoys a fast paced, dynamic work environment.  The Associate Director will be responsible for developing key EMEA regulatory strategies and executing submissions while monitoring and assessing EMEA regulations including Gene Therapy guidance and regulation changes. This position will report to the Vice President, Head of Regulatory Affairs, EMEA. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Or

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Interfaces with EMEA regulatory agencies as appropriate on select programs. 
• Independently researches options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership. 
• Represent EMEA Regulatory in sub team meetings, serving as the point of contact for the assigned products in the EMEA region, and interfacing with functional areas including Research, Development and Clinical in strategic development for early and late-stage products. 
• Provide regulatory guidance for the EMEA region and input throughout product development to the regulatory sub team. 
• Lead cross functional teams in EMEA Regulatory Filings (e.g. CTAs, GMOs, MAAs) 
• Lead select Regulatory vendor meetings in alignment with product programs and Regulatory-driven projects 
• Maintain CTAs ensuring Agency compliance 
• Review clinical documentation, including protocols, DSUR’s, Investigator Brochures, Investigator Packages and General Investigational Plans to ensure GCP and Agency compliance 
• Lead teams in the development of briefing documents for EMEA Agency meetings 
• Manage and direct contractors/vendors as needed on programs 
• Keep current with EMEA Agency guidelines and regulations 
• Prepare comments on draft documentation sent out for consultation from the health authority 
• Contribute to creation of local labels as needed 
• Coordinate submission schedule with Publishing, ensuring delivery of high-quality documents 
• Participate on cross-functional committees and sub-teams in accordance with company initiatives, as necessary 
• Provides supervision and mentoring to junior regulatory professionals on the team, if applicable 

Requirements:

• BA/BS in a scientific field of study or BA/BS in another field of study and 8 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry, including preferred experience with Gene Therapies and other compounds for the treatment of rare diseases 
• Strong knowledge and experience in interpretation of EMEA 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, teamwork, organizational skills at attention to detail 
• Requires initiative, creative problem-solving ability and excellent verbal and written communication skills 

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