Senior Manager, Regulatory Affairs Labeling Product Leader

About the role

The Senior Manager, Regulatory Affairs Labeling Product Leader will be responsible for:

• Driving the global labeling strategy
• Partnering with Global Regulatory Leads and other functional area partners to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned products
• Leading target labeling development
• Collaborating with functional areas to provide labeling input relevant to clinical study protocols and ensure alignment on endpoints and Patient-Reported Outcomes (PROs)
• Providing strategic labeling advice for local labeling in major markets
• Leading Health Authority (HA) labeling strategy discussions and development of contingency labeling plans and content
• Leading the development, revision, review, agreement, and maintenance of target labeling, primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents) for assigned compounds
• Leading cross-functional Labeling Working Group (LWG) and strategic labeling discussions leading to development of target and primary labeling
• Representing global labeling in Global Regulatory teams and other cross-functional teams, as appropriate
• Presenting at governance meetings, such as Labeling Committee, to seek endorsement of labeling
• Providing advice and guidance about labeling content, processes, timelines, and scientific integrity
• Cooking the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation
• Ensuring high quality and compliant labeling documents
• Supporting global labeling inspections and audits for assigned products, as applicable

Responsibilities

The Senior Manager, Regulatory Affairs Labeling Product Leader will be responsible for:

• Drive the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area, their development plans and status and knowledge of labeling aspects for labeling development and target labeling for new products.
• Lead target labeling development.
• Collaborate with functional areas to provide labeling input relevant to clinical study protocols and ensure alignment on endpoints and Patient-Reported Outcomes (PROs), with a label-as-driver approach.
• Provide strategic labeling advice for local labeling in major markets.
• Analyze relevant competitor labeling, leverage labeling guidance and trends to develop labeling strategy and content, including risk and mitigation identification and assessment.
• Lead Health Authority (HA) labeling strategy discussions and development of contingency labeling plans and content.
• Lead the development, revision, review, agreement, and maintenance of target labeling, primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents) for assigned compounds.
• Lead cross-functional Labeling Working Group (LWG) and strategic labeling discussions leading to development of target and primary labeling.
• Represent global labeling in Global Regulatory teams and other cross-functional teams, as appropriate.
• Present at governance meetings, such as Labeling Committee, to seek endorsement of labeling.
• Provide advice and guidance about labeling content, processes, timelines, and scientific integrity.
• Cook the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation.
• Ensure high quality and compliant labeling documents.
• Support global labeling inspections and audits for assigned products, as applicable.

Requirements

A minimum of a Bachelor’s degree in a scientific discipline is required. Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.

A minimum of 8 years of professional work experience is required. A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required. Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred.

Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required. An understanding of pharmaceutical drug development is required. Experience in discussing and communicating scientific concepts is required. Good understanding of worldwide regulatory guidelines and their application for guidance for labeling is required. Experience leading project teams in a matrix environment is required. Experience leading continuous improvement projects is required. Experience working with document management systems is required. Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.

Must have exceptional verbal and written communication skills. Must have strong organizational, negotiation, and partnering skills. Must have the ability to work independently. The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred. The ability to drive a collaborative, customer-focused, learning culture is preferred.

Qualifications

• A minimum of a Bachelor’s degree in a scientific discipline is required.
• An advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.
• A minimum of 8 years of professional work experience is required.
• A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required.
• Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred.
• Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
• An understanding of pharmaceutical drug development is required.
• Experience in discussing and communicating scientific concepts is required.
• A good understanding of worldwide regulatory guidelines and their application for guidance for labeling is required.
• Experience leading project teams in a matrix environment is required.
• Experience leading continuous improvement projects is required.
• Experience working with document management systems is required.
• Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.

Skills

• Analytical Reasoning
• Business Writing
• Compliance Risk
• Fact-Based Decision Making
• Industry Analysis
• Legal Support
• Mentorship
• Organizing
• Product Licensing
• Public Policies
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Risk Assessments
• Strategic Thinking
• Technical Credibility

Benefits

• Consolidated Retirement Plan (Pension)
• Savings Plan (401(k))
• Long-Term Incentive Program
• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year