Senior GRA Labeling Manager

Job Title: Senior GRA Labeling Manager

Job Description

The Senior Manager / Associate Director, Global Regulatory Affairs (GRA) Labeling will serve as a Global Labeling Lead within the Regulatory Affairs organization, reporting to the Head of Labeling. This role has been created to support continued growth in products and regulatory submissions, resulting in increased global labeling development and lifecycle maintenance activities. The position holds full ownership of labeling strategy and execution for two products, including an Oncology product, and requires an experienced labeling professional who can quickly operate independently and partner closely with cross-functional teams to drive strategic decisions. The focus will be on leading global labeling strategy and content development for Company Core Data Sheets (CCDS), U.S. Prescribing Information (USPI), and European labeling, with an initial emphasis on the US and EU. This is a highly visible and collaborative role that requires strong leadership, the ability to lead cross-functional discussions, and confidence in presenting and defending labeling strategy in a regulatory submissions environment.

Responsibilities

• Serve as the Global Labeling Lead for assigned products, including an Oncology product and an additional product, with full accountability for labeling strategy and execution.
• Own the development, revision, and maintenance of Company Core Data Sheets (CCDS), U.S. Prescribing Information (USPI), European labeling, and related global labeling documents.
• Lead cross-functional labeling meetings and decision-making forums to ensure alignment on labeling content and strategy.
• Drive labeling strategy by interpreting applicable regulations, guidance, and precedent to support permissible claims and clear, compliant product information.
• Present labeling content, rationale, and strategic recommendations to internal stakeholders, including Senior leadership and cross-functional teams.
• Gather, evaluate, and address cross-functional feedback on labeling proposals and guide teams toward alignment and timely decisions.
• Plan, organize, and execute labeling changes through established governance structures, review committees, and approval workflows.
• Support global regulatory submissions by providing high-quality labeling content and ensuring consistency across core and local labels.
• Author, review, and manage labeling documents within an electronic document management system as part of the regulatory submissions lifecycle.
• Collaborate closely with Product Teams and Global or Regional Regulatory Leads to ensure labeling strategy is integrated with overall product and regulatory plans.
• Independently manage global labeling deliverables, timelines, and priorities in a fast-paced environment.

Essential Skills

• Proven prior experience functioning as a Labeling Lead with primary ownership of labeling deliverables, not only in a support capacity.
• Demonstrated ability to independently manage global labeling deliverables across development, maintenance, and lifecycle management.
• Strong knowledge of US and EU labeling regulations, guidance, and requirements, including Core Data Sheets and their role in global labeling strategy.
• Ability to lead cross-functional teams, facilitate discussions, and drive consensus on complex labeling issues.
• Confidence in making labeling decisions and presenting clear, well-justified recommendations to stakeholders.
• Strong organizational, planning, and execution skills with the ability to operate effectively in a fast-paced, evolving environment.
• Minimum of 3+ years of direct sponsor-side Regulatory Labeling experience.
• Pharmaceutical or biotechnology industry experience in a sponsor environment.
• Experience serving as a Global or Product Labeling Lead.
• Background in content labeling (clinical and safety content) rather than packaging labeling.
• Regulatory Affairs Background, with experience focused on regulatory labeling rather than quality-focused roles.
• Experience with global labeling lifecycle management, including updates driven by new data, safety findings, and regulatory feedback.

Additional Skills & Qualifications

• Bachelor’s degree in a scientific discipline is required, with biosciences preferred.
• Advanced degree such as MS, PharmD, or PhD is a plus.
• Experience working within an electronic document management system for authoring, reviewing, and managing labeling documents is strongly preferred.
• Exposure to Rest of World labeling is beneficial, even though the initial focus will be on US and EU.
• Experience in an environment with growing product portfolios and increasing regulatory submissions is advantageous.
• Strong communication skills, including the ability to clearly explain complex regulatory and scientific concepts to diverse stakeholders.
• Demonstrated ability to collaborate effectively with cross-functional partners such as clinical, safety, medical, and commercial teams.

Work Environment

This is a remote position aligned to East and Central time zones. The role operates within a highly collaborative Global Regulatory Affairs and Labeling function, working extensively in electronic systems for document authoring, review, and lifecycle management. The environment is fast paced and growth oriented, with high visibility to leadership and significant strategic impact on key products, particularly in Oncology. The culture emphasizes cross-functional collaboration, accessible leadership, and opportunities to shape labeling strategy within an evolving regulatory organization.

This is a Contract position based out of Wilmington, DE.

The pay range for this position is $80.00 - $80.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on May 5, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.