Associate Director, Regulatory Affairs Labeling Product Leader
About The Position
About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Labeling Product Leader. This position is a hybrid role and will be located in Raritan, NJ; Titusville, NJ; or Horsham, PA. The Associate Director, Regulatory Affairs Labeling Product Leader will be responsible for the following: 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 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.
- Must have exceptional verbal and written communication skills.
- Must have strong organizational, negotiation, and partnering skills.
- Must have the 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.
- 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.
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
- This role may collaborate with external partners.
Benefits
- medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- consolidated retirement plan (pension) and 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 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
- Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave - 10 days
- Volunteer Leave - 4 days
- Military Spouse Time-Off - 80 hours
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
