[Hiring] Manager / Senior Manager – Global Regulatory Labelling @Nexiva

Role Description

Client is seeking an experienced Manager/Senior Manager in Global Regulatory Labelling to support its Core Labelling Strategy Team on a contract basis. The ideal candidate will have strong expertise in global regulatory labelling, including the development and maintenance of Company Core Data Sheets (CCDS), US Prescribing Information (USPI), and EU Summary of Product Characteristics (SmPC).

This role will collaborate with cross-functional teams, including Global Regulatory Affairs, Medical, Safety, and Clinical, to ensure product labelling complies with applicable global regulatory requirements and supports overall product and regulatory strategy.

• Lead and manage global regulatory labelling activities for assigned products and portfolios.
• Develop, review, and maintain global core labelling documents, including CCDS, Target Product Labelling (TPL), and Core Patient Information.
• Support the development and maintenance of regional labelling documents, including USPI and EU SmPC.
• Partner with Global Regulatory Affairs, Medical, Safety, and Clinical teams to develop effective labelling strategies.
• Evaluate clinical and non-clinical data to ensure labelling accuracy, scientific relevance, and regulatory compliance.
• Assess differences between company core labelling and regional product information and support responses to health authority requests.
• Lead or participate in Product Labelling Teams (PLTs) and escalate significant issues to the Global Labelling Committee (GLC), as appropriate.
• Conduct competitive labelling analysis and assess regulatory precedents to support product strategy.
• Review promotional and non-promotional materials for consistency with approved product labelling and applicable regulations.
• Support regulatory submissions and review relevant documents, including Investigator's Brochures (IBs), clinical study reports (CSRs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).
• Monitor evolving global regulatory guidelines and provide recommendations on labelling strategy.

Qualifications

• Bachelor's degree in Science, Medicine, Pharmacy, or a related field.
• Typically 7–10+ years of regulatory affairs experience, including significant hands-on regulatory labelling experience.
• Demonstrated experience developing and maintaining global core labelling documents, particularly CCDS.
• Strong knowledge of USPI and EU SmPC requirements.
• Experience supporting global regulatory labelling strategy and product lifecycle management.
• Understanding of FDA and EMA regulatory requirements.
• Experience collaborating with cross-functional teams in a matrixed environment.
• Strong communication, analytical, presentation, and stakeholder management skills.
• Ability to work independently and manage complex regulatory labelling issues.

Requirements

• Advanced degree such as MSc, PharmD, or PhD.
• Experience supporting NDA, BLA, or MAA regulatory submissions.
• Experience with Target Product Labelling (TPL) development.
• Background in competitive labelling analysis and regulatory precedent assessment.
• Experience participating in Product Labelling Teams (PLTs) and Global Labelling Committees (GLCs).

Ideal Candidate Profile

The ideal candidate is a seasoned regulatory labelling professional at the Manager or Senior Manager level who can independently manage global core labelling activities, influence cross-functional stakeholders, and support strategic labelling decisions across the product lifecycle.