Associate Director, Global Regulatory Affairs – Labeling
Job Description:
• Provides global labeling leadership in support of the development, registration, and life-cycle management of Ultragenyx products for rare diseases.
• Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources.
• Demonstrate the ability to work in a matrix environment communicating label concepts and key messaging during label development consistent with program strategy and understanding and educating the impact to downstream activities (i.e., for commercial, and promotional educational purposes).
• Build strong collaboration with key internal stakeholders, including Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain, and other functions to support development of draft label text.
• Interact with the cross functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes in local product information that are consistent with the company’s position defined in the CCDS and in compliance with local labeling regulations.
• Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables that meet regulatory standards, and corporate and program milestones. Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution of complex label issues and ability to drive consensus utilizing current standard operating procedures, best practices and/or work instructions including work requests associated with partner companies and vendors.
• Facilitate and lead target label strategies with cross functional labeling team incorporating key messaging aligned with target product profile and thorough understanding of competitive landscape environment. Provide necessary label output for HA interactions (i.e., FDA/EMA/PMDA/HC briefing book, scientific advice, and/or other key submission readiness milestones).
• Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available and accessible for global submissions and inspection readiness.
• Contribute to the review and approval of artwork supporting global submissions.
• Implement and maintain a quality control measure during all stages of label development.
• Maintain knowledge base of current global rules, regulations, and relevant guidance (draft or final) governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s).
• Initiate or contribute to local and/or global process and/or system improvements which have a significant impact on business.
Requirements:
• Minimum BA/BS degree in life sciences. Advanced degree preferred.
• Strong scientific background with 8 years’ experience in the biotechnology and/or pharmaceutical industry including at least 4+ years in a global regulatory/labeling position.
• Excellent attention to detail with solid coordinating, task planning and time management skills.
• Excellent verbal, written and interpersonal communication skills.
• Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
• Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making in a collaborative way, and implementing plans and risk mitigation strategies.
• Thorough understanding of global drug development regulations and guidelines.
• Willingness to work in a dynamic, fast paced and changing corporate environment where roles and responsibilities are not well defined.
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
Apply tot his job
Apply To this Job
• Provides global labeling leadership in support of the development, registration, and life-cycle management of Ultragenyx products for rare diseases.
• Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources.
• Demonstrate the ability to work in a matrix environment communicating label concepts and key messaging during label development consistent with program strategy and understanding and educating the impact to downstream activities (i.e., for commercial, and promotional educational purposes).
• Build strong collaboration with key internal stakeholders, including Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain, and other functions to support development of draft label text.
• Interact with the cross functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes in local product information that are consistent with the company’s position defined in the CCDS and in compliance with local labeling regulations.
• Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables that meet regulatory standards, and corporate and program milestones. Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution of complex label issues and ability to drive consensus utilizing current standard operating procedures, best practices and/or work instructions including work requests associated with partner companies and vendors.
• Facilitate and lead target label strategies with cross functional labeling team incorporating key messaging aligned with target product profile and thorough understanding of competitive landscape environment. Provide necessary label output for HA interactions (i.e., FDA/EMA/PMDA/HC briefing book, scientific advice, and/or other key submission readiness milestones).
• Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available and accessible for global submissions and inspection readiness.
• Contribute to the review and approval of artwork supporting global submissions.
• Implement and maintain a quality control measure during all stages of label development.
• Maintain knowledge base of current global rules, regulations, and relevant guidance (draft or final) governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s).
• Initiate or contribute to local and/or global process and/or system improvements which have a significant impact on business.
Requirements:
• Minimum BA/BS degree in life sciences. Advanced degree preferred.
• Strong scientific background with 8 years’ experience in the biotechnology and/or pharmaceutical industry including at least 4+ years in a global regulatory/labeling position.
• Excellent attention to detail with solid coordinating, task planning and time management skills.
• Excellent verbal, written and interpersonal communication skills.
• Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
• Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making in a collaborative way, and implementing plans and risk mitigation strategies.
• Thorough understanding of global drug development regulations and guidelines.
• Willingness to work in a dynamic, fast paced and changing corporate environment where roles and responsibilities are not well defined.
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
Apply tot his job
Apply To this Job