Senior Manager, Core Labeling Strategy

Adecco Healthcare & Life Sciences is seeking an experienced Senior Manager, Core Labeling Strategy to support its Global Regulatory Affairs team on a six-month contract assignment. This role will lead global regulatory labeling strategy and ensure product labeling for existing and new products meets applicable regulatory requirements and company standards.

The ideal candidate will bring extensive pharmaceutical labeling experience, strong scientific and regulatory expertise, and the ability to collaborate across global, cross-functional teams.

Location: 100% remote, US based
Employment Type: 6-Month Temporary Contract
Schedule: Full-Time Commitment
Start Date: ASAP
Compensation: Salary commensurate with experience

Key Responsibilities

• Lead the development, review, approval, and maintenance of global core labeling documents, including Company Core Data Sheets (CCDS), Target Product Labeling (TPL), and core patient information.

• Oversee territorial labeling requirements, including U.S. Prescribing Information (USPI) and European Summary of Product Characteristics (SmPC).

• Develop and implement labeling strategies aligned with global regulatory objectives and business priorities.

• Evaluate clinical and nonclinical data to ensure labeling accuracy, scientific integrity, and regulatory compliance.

• Partner with Regulatory Affairs, Medical, Drug Safety, and Clinical teams to support labeling decisions and product lifecycle management.

• Assess labeling differences across regions and support responses to Health Authority questions.

• Lead or participate in Product Labeling Teams (PLTs) and escalate key issues to the Global Labeling Committee (GLC) as appropriate.

• Monitor competitor labeling, emerging regulatory guidance, and industry trends to inform labeling strategy.

• Review promotional and non-promotional materials for consistency with approved labeling and applicable regulatory requirements.

• Provide labeling expertise for regulatory submissions and scientific documents, including NDA/BLA/MAA submissions, investigator brochures, clinical study reports, and risk management plans, as applicable.

Required Qualifications

• Bachelor's degree or equivalent in Science, Medicine, Pharmacy, or a related field.

• Typically 7–10 years of relevant experience, including significant pharmaceutical regulatory labeling experience.

• Demonstrated expertise in developing and maintaining global core labeling, including CCDS, USPI, and EU SmPC.

• Strong understanding of U.S. and European labeling regulations and global regulatory requirements.

• Experience developing Target Product Labeling and conducting competitive labeling assessments.

• Experience supporting regulatory submissions and product lifecycle management.

• Proven ability to lead projects and influence cross-functional stakeholders in a matrixed environment.

• Excellent written, verbal, presentation, and stakeholder management skills.

• Strong analytical skills and the ability to interpret complex scientific and regulatory information.

Preferred Qualifications

• Advanced degree in a relevant discipline, such as an MSc, PharmD, or PhD.

• Experience supporting NDA, BLA, or MAA submissions.

• Experience with global labeling governance, regulatory strategy, and Health Authority interactions.

Pay Details: $70.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.