Senior Manager, Regulatory Affairs Labeling Product Leader

Johnson & Johnson Innovative Medicine • Horsham, PA

10d • $137,000 - $235,750 • Hybrid

About The Position

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, Regulatory Affairs Labeling Product Leader. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA. The Senior Manager, Regulatory Affairs Labeling Product Leader will be responsible for driving 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. This role will take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners (clinical, safety, market access, commercial, medical affairs) to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned products. The role will lead target labeling development and 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. Additionally, the role will 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. The Senior Manager will lead Health Authority (HA) labeling strategy discussions and development of contingency labeling plans and content. They will 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. This role will lead cross-functional Labeling Working Group (LWG) and strategic labeling discussions leading to development of target and primary labeling. The Senior Manager will represent global labeling in Global Regulatory teams and other cross-functional teams, as appropriate, and present at governance meetings, such as Labeling Committee, to seek endorsement of labeling. They will provide advice and guidance about labeling content, processes, timelines, and scientific integrity, coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation, and ensure high quality and compliant labeling documents. The role will contribute to the continuous improvement of the end-to-end labeling process and support global labeling inspections and audits for assigned products, as applicable. This role may collaborate with external partners.

Requirements

• A minimum of a Bachelor’s degree in a scientific discipline is required.
• 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.
• 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.
• Exceptional verbal and written communication skills.
• Strong organizational, negotiation, and partnering skills.
• Ability to work independently.

Nice To Haves

• Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.
• Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred.
• Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.
• Ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred.
• Ability to drive a collaborative, customer-focused, learning culture is preferred.

Responsibilities

• 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.
• Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners (clinical, safety, market access, commercial, medical affairs) to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned 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.
• Coordinate 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.
• Contribute to the continuous improvement of the end-to-end labeling process.
• Support global labeling inspections and audits for assigned products, as applicable.
• Collaborate with external partners.

Benefits

• 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
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior