Senior Manager for Core Labelling Strategy Team

Dear Applicant,

Please let me know if interested.

Job Title: Senior Manager for Core Labelling Strategy TeamLocation: Remote EST time zoneJob Type: - ContractJob Description:-POSITION PURPOSE

A brief summary of the purpose this position must fulfill.

Provide global regulatory labelling expertise and leadership to ensure Product Information (labelling) for both

existing and new products is developed, maintained, and implemented in compliance with applicable

regulatory requirements.

The role is responsible for the development and maintenance of Core Labelling (including CCDS and

associated patient information) and supports Global Ad Promo and Medical/Commercial material review and

approval in line with company principles and procedures.

Additionally, the role contributes to strategic labelling activities across the product lifecycle, including Target

Product Labelling (TPL), competitive labelling analysis, and regulatory precedent assessment to support global

regulatory strategy and major submissions (e.g. USPI, EU SmPC).

All activities are performed in accordance with applicable SOPs, regulatory requirements, and company

policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this position successfully, an individual must satisfactorily perform each essential duty.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential

duties.

· Accountable for management and delivery of labelling activities across assigned products/portfolio.

· Leads development, preparation, review, and approval of global labelling documentation (e.g. TPL,

CCDS, Core Patient Information) and territorial labelling (e.g. EU SmPC, USPI) based on clinical and

non-clinical data.

· Leads or supports development of labelling strategy in partnership with Global Regulatory, ensuring

alignment with overall regulatory strategy and business objectives.

· Contributes to development and maintenance of Target Product Labelling (TPL) to support early

development, regulatory positioning, and cross-functional alignment.

· Establishes strong cross-functional partnerships with Regulatory Strategists, Medical, Safety, and

Clinical teams to ensure proactive and effective labelling development.

· Leads labelling updates and development, critically evaluating supporting data to ensure scientific

accuracy, clinical relevance, and regulatory acceptability.

· Assesses and reconciles deviations from Company Core Position (e.g. CCDS) and supports responses

to Health Authority requests.

· Chairs or actively contributes to Product Labelling Teams (PLTs), ensuring appropriate cross-functional

input. Escalates key issues to the Global Labelling Committee (GLC) as required.

· Maintains strong awareness of competitor labelling, evolving regulatory requirements, and external

trends to inform labelling strategy.

· Manages complex regulatory and scientific labelling issues, balancing compliance, business needs,

and risk.

· Contributes to interpretation and application of emerging regulatory guidelines impacting labelling.

· May represen in external forums (e.g. industry groups, EMA/FDA workshops).

· Reviews and approves promotional and non-promotional materials for alignment with CCDS and

applicable codes and requirements.

· Reviews and advises on key scientific and regulatory documents (e.g. IB, protocols, CSR, PSURs,

RMPs) as appropriate.

· Provides labelling expertise in cross-functional and regulatory team discussions.

· Performs other labelling-related duties as assigned.

QUALIFICATIONS

The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE

• Regulatory experience with strong knowledge of global labelling across development and lifecycle

management.

• Understanding of PLT and GLC governance frameworks and EU/US labelling requirements (SmPC,

USPI, CCDS).

• Experience with TPL development and competitive labelling analysis.

• Experience supporting labelling for regulatory submissions in major markets (e.g. US, EU).

• Prior leadership experience or demonstrated ability to lead and influence others in a matrix environment.

SKILLS AND ABILITIES

Highly developed interpersonal, presentation and communication skills. Ability to provide innovative

approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with

relevant laws and regulations. The ability to influence effectively in a matrixed, cross-functional team

environment

SUPERVISION

Position functions autonomously. The position may directly supervise employees. Carry out supervisory

responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may

include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising

performance; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION/EXPERIENCE

• Bachelor’s degree (or equivalent) in Science, Medicine, Pharmacy, or related field with typically 7–10

years of experience, including significant labelling experience.

• Demonstrated experience in development and maintenance of global core labelling (e.g. CCDS) and

major market labelling (e.g. USPI, EU SmPC).

• Experience supporting regulatory submissions (e.g. NDA/BLA/MAA) preferred.

• Advanced degree (MSc, PharmD, PhD) is advantageous but not required.

• Experience in TPL development, competitive labelling benchmarking, and regulatory strategy support is

an advantage.

LICENSES/CERTIFICATIONS

None required.

LANGUAGE SKILLS

Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports

and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to

present to a high level of the organization and groups outside of the organization.

MATHEMATICAL SKILLS

Ability to perform computations such as percentages, ratios, and rates.

REASONING ABILITY

Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require

some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve

moderately complex problems.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to

successfully perform the essential duties of this position. Reasonable accommodations may be made

to enable individuals with disabilities to perform essential duties.

Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required.

May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of

arms.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee

encounters while performing the essential duties of this position. Reasonable accommodations may be

made to enable individuals with disabilities to perform essential duties.

Normal office situation with flexible working.