Senior Director, Global Regulatory Affairs – Labeling
Ultragenyx
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $243,800 - $301,100 per year
Job Level
About the role
- Lead the Global Labeling function for Ultragenyx and serve as an internal expert on health agency regulations and guidelines.
- Accountable for oversight of the labeling process at Ultragenyx for all programs in development through commercialization.
- Provide strategic and operational leadership in accordance with business goals and objectives, regulations, and guidelines.
- Guide, develop and author draft labeling text (e.g., USPI, PPI, MedGuide, EU SmPC, EU PIL) to support marketing applications and labeling updates of approved package inserts to support product lifecycle management.
- Ensure labeling strategy is aligned with overall regulatory and program strategy by working closely with the regulatory head, strategy lead and development and project teams.
- Confirm labeling is compliant with US and EU regulatory requirements.
- Develop and maintain CCDS.
- Provides strategic regulatory guidance and expert advice on current labeling requirements, templates, tools and Health Authority-issued guidance across the portfolios globally.
- Chairs the process to obtain labeling approval by Senior Management providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.
- Ability to lead, manage, motivate, mentor and develop a diverse team of Global Labeling Strategy Leads accountable for developing and reviewing and finalizing labeling across all development programs through commercialization.
- Ability to lead, manage, motivate and develop Global Labeling Operations Leads accountable for overseeing packaging and artwork strategies across all commercial product lifecycles.
Requirements
- BSc Degree preferred and advanced scientific degree (MSc, PhD, or PharmD) a plus.
- A minimum of 12 years’ experience in the biotechnology or pharmaceutical industry with extensive global labeling experience.
- Significant pharmaceutical background with focus on regulatory and/or both development and post-marketing phases in the US and EU.
- Strong understanding of global labeling processes, and implications across the organization.
- Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals.
- Crisp decision making following appropriate consultation, even in times of ambiguity.
- Strong writing skills, able to process scientific data and effectively summarize into the appropriate detail for labeling content.
- Strong oral and written communication skills, negotiation skills, integrity and adaptability
- Demonstrate leadership skills, ability to inspire colleagues and influence in a matrixed organization.
- Ability to work towards solutions with a collaborative mindset.
- Excellent teamwork and interpersonal skills, both internally and externally.
- Strategic thinker, open-minded and flexible in adopting new and creative ideas.
- Willingness to work in a dynamic and changing corporate environment.
- Rare disease experience is desirable.
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
labeling processlabeling textUSPIPPIMedGuideEU SmPCEU PILCCDSregulatory guidancelabeling compliance
Soft Skills
leadershipmentoringcollaborationdecision makingcommunicationnegotiationadaptabilityteamworkstrategic thinkingproblem solving
Certifications
BSc DegreeMScPhDPharmD