Senior Manager, Regulatory Affairs Labeling Product Leader

The Senior Manager, 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.

Qualifications:

• 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.

Johnson & Johnson is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.  We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.  If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

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

The anticipated base pay range for this position is :

$137,000.00 - $235,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits