Labelling Strategy Associate Director

Labelling Strategy Associate Director

Alternate/Related Job Titles

• Labeling Strategist
• Labeling Manager
• Labeling Specialist (Strategy-focused)
• Regulatory Affairs Labeling Associate Director

Location

Gaithersburg, MD

Onsite Flexibility

Remote

Contract Details

• Position Type: Contract
• Contract Duration: 12 months (no possible conversion)
• Pay Rate: $65.00 $72.00 / Hour (USD)
• Shift / Schedule: 8 AM 5 PM; willingness to accommodate occasional early-morning or late-afternoon calls to coordinate with international colleagues
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

The Labelling Strategy Associate Director provides regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET) and cross-functional Product Labelling Teams (PLT). This individual leads the development and implementation of the labelling strategy and maintenance of Core Product Information and United States (US)/European Union (EU) Market Product Information (MPI) for assigned marketed or pipeline products. The individual contributes to the development of the labelling group by sharing knowledge and mentoring peers.

The role focuses on strategic scientific and regulatory wording/content that goes into the Prescribing Information (Package Insert) for US Labeling, Company Core Data Sheet (CCDS/Core Labeling), and EU Labeling (SmPC) this is not an artwork/graphics role; the focus is on drafting and agreeing on actual regulatory text. The primary system used is ERV, an internal electronic repository based on Veeva Vault.

Key Responsibilities

• Ensures that the labelling process is followed through the lifecycle of the product.
• Ensures all work is performed in accordance with established procedures, regulatory requirements, and GxPs.
• Leads the development of the labelling strategy, in line with the overall regulatory strategy for the product, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider portfolio.
• Leads the PLT in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
• Leads the development of labelling negotiation strategies, anticipating HA perspectives.
• Provides labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance.
• Provides clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigations.
• Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling.
• Ensures appropriate communication across Labelling subfunctions.
• Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision-making.
• Leads the development of target labelling documents as appropriate.
• Assists in the development of labelling policies, procedures and SOPs.
• Organizes and chairs Product Labelling Team meetings.
• Collaborates cross-functionally across Regulatory Affairs, Clinical, Safety/Pharmacovigilance, and Commercial to reach consensus on labeling language.
• Performs document research, justifies proposed label text, guides changes through governance committees, and manages labeling documents through final approval.
• Manages strategic labeling deliverables across one or more assigned commercial or development products (depending on product complexity).

Required Skills

• Minimum of 3+ years of direct experience in regulatory pharmaceutical labeling strategy (developing prescribing information, core data sheets, or US/EU package inserts); must be able to hit the ground running without needing training on core labeling concepts.
• Direct experience within a GxP/regulated pharmaceutical or biotech industry environment.
• Knowledge of labelling regulations and guidances.
• Excellent verbal and written communication skills; ability to interact confidently and effectively with senior leadership to get labels approved.
• Keen attention to detail and accuracy.
• Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
• Ability to assimilate clinical and scientific information and present it in a concise manner.
• Ability to think strategically, appropriately assess risks and formulate strategies to manage risk.
• Building Relationships: works well across formal and informal networks.
• Negotiation Skills: good listener; able to build a consensus.
• Critical Information Seeking: works well across formal and informal networks.
• Rational Persuasion: able to distill an issue to its key components and suggest solutions.
• Interpersonal Awareness: aware of how actions affect other people.
• Proven ability to drive meetings, influence decisions, and build consensus among cross-functional scientific and commercial stakeholders.

Preferred Skills

• Experience in labelling development and/or maintenance.
• Knowledge of major markets' labelling regulations.
• Veeva Vault experience; prior experience in Veeva Vault (or ERV setup) is an asset (though training will be provided).
• Global/international experience: experience collaborating with international teams across different time zones (US, Europe, Spain, Sweden, Canada, India) and working with external pharmaceutical partner companies.
• Schedule flexibility: willingness to accommodate occasional early-morning or late-afternoon calls to coordinate with international colleagues.

Education Requirements

• University Degree in Science or related discipline (minimum Bachelor's degree; hands-on experience is prioritized).
• Advanced academic training is highly desirable (PharmD, PhD).

Required Experience

• 3 to 5 years of pharmaceutical experience, including regulatory experience, preferably working with labelling.
• Minimum of 3+ years of direct, hands-on experience in regulatory pharmaceutical labeling strategy.

Nice-to-Have Experience

• Experience in labelling development and/or maintenance.
• Experience collaborating with international teams across different time zones and working with external pharmaceutical partner companies.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Important Notes

• Interview Process: 1-round virtual video interview via Microsoft Teams (approximately 1 hour) with the hiring manager and one colleague.
• Target Start: As soon as possible (aiming for the beginning of the new year / January).

About the Client

This global biopharmaceutical company operates across more than 100 countries and is driven by a defining mission to push the boundaries of science and deliver life-changing medicines that transform the lives of patients worldwide. The organization focuses on three core therapy areas oncology, cardiovascular and metabolic disease, and respiratory and immunology while also advancing treatments in rare diseases and vaccines, with a pipeline consistently regarded as one of the most productive in the industry.

Employing tens of thousands of scientists, clinicians, and business professionals globally, this organization combines the resource depth of a top-tier pharma company with a genuine culture of scientific curiosity. Research programs span small molecules, biologics, cell therapy, and RNA technologies, giving employees exposure to the full frontier of modern drug development. In 2026, employees voted this organization onto Glassdoor's Best Places to Work list, and it holds an overall Glassdoor rating of 4.0 stars from nearly 8,000 reviews, with 79% of employees saying they would recommend working here to a friend.

The organization has built a strong reputation for scientific career development, with structured pathways for researchers, clinical professionals, and commercial staff. Teams here span oncology researchers, clinical trial specialists, regulatory scientists, and commercial and market access professionals.

About GTT

GTT is an NMSDC-certified Minority Business Enterprise (MBE) headquartered in Portsmouth, New Hampshire. GTT is a subsidiary of Chenega Corporation, an Alaska-based company and one of the largest Alaska Native-owned corporations. An Inc. 5000 honoree and one of SIA's Best Staffing Firms to Work For, GTT connects professionals with Fortune 500 organizations across IT, engineering, construction, utilities, life sciences, financial services, and healthcare throughout the U.S. and Canada. We're committed to diverse, inclusive workplaces and to placing people in roles where they can do their best work.

Job Number:

26-18590