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Manager Global Labeling Operations Jobs in Delaware

Rubrik

Senior Manager, Global Deal Desk

Dover, DE · On-site

$168K - $253K/yr

Senior Manager, Global Deal Desk - AMER Location: AMER We are seeking a Senior Manager, Global Deal ... Effectively resolve and champion conflicts arising between internal operational processes and ...

New

AMS Fulfillment

Senior Operations Manager

Bear, DE · On-site

$90K - $125K/yr

... senior management position responsible for all areas of assigned operations and requires heavy ... Including the accompanying skills of EDI labeling, charge back avoidance, routing guide adherence ...

Rubrik

Global Solutions Architect

Dover, DE · On-site

Act as the field's most credible voice into Product Management and Engineering, backed by evidence ... Work with PS Operations and leadership to turn field learning into better scoping models, estimates ...

New

MSD Malaysia

Operations Manager

Millsboro, DE · On-site

We work in the local plant connected to our global manufacturing network to ensure the highest ... Inventory Management * Manufacturing Quality Control * Operational Excellence * Packaging ...

Merck & Co., Inc.

Operations Manager

Millsboro, DE · On-site

We work in the local plant connected to our global manufacturing network to ensure the highest ... Management, Manufacturing Quality Control, Operational Excellence, Packaging Operations, People ...

MSD

Operations Manager

Millsboro, DE · On-site

We work in the local plant connected to our global manufacturing network to ensure the highest ... Management, Manufacturing Quality Control, Operational Excellence, Packaging Operations, People ...

Merck & Co.

Operations Manager

Millsboro, DE · On-site

We work in the local plant connected to our global manufacturing network to ensure the highest ... Management, Manufacturing Quality Control, Operational Excellence, Packaging Operations, People ...

Merck & Co.

We work in the local plant connected to our global manufacturing network to ensure the highest ... Management, Manufacturing Quality Control, Operational Excellence, Packaging Operations, People ...

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Manager Global Labeling Operations information

What is a Manager Global Labeling Operations?

A Manager Global Labeling Operations oversees the development, review, and maintenance of product labeling for pharmaceuticals or medical devices on a global scale. They ensure that labeling meets regulatory requirements in different countries and manage cross-functional teams to align labeling content with company and legal standards. This role often involves coordinating updates, supporting product launches, and handling label changes due to regulatory or safety updates. Strong project management and regulatory knowledge are essential for this position.

What are the key skills and qualifications needed to thrive as a Manager Global Labeling Operations?

To thrive as a Manager Global Labeling Operations, you need expertise in regulatory affairs, labeling requirements, and project management, often supported by a relevant science degree and experience in the pharmaceutical or medical device industry. Familiarity with regulatory submission systems, labeling management software, and knowledge of global health authority regulations are typically required. Strong leadership, cross-functional communication, and problem-solving skills help you navigate complex international projects and teams. These competencies ensure timely, compliant labeling that supports product approvals and global market success.

What are some common challenges faced by a Manager Global Labeling Operations, and how can they be effectively addressed?

A Manager Global Labeling Operations often contends with challenges such as coordinating labeling requirements across multiple international markets, ensuring compliance with frequently changing regulations, and managing cross-functional collaboration with regulatory, quality, and supply chain teams. Staying organized and maintaining clear communication channels are key to overcoming these hurdles. Leveraging robust project management tools and keeping up-to-date with global regulatory trends can help streamline processes and minimize errors, ensuring timely and accurate label updates.

What is the difference between Manager Global Labeling Operations vs Labeling Specialist?

AspectManager Global Labeling OperationsLabeling Specialist
CredentialsTypically requires a bachelor’s degree in life sciences, pharmacy, or related field; often with project management certificationsUsually holds a relevant degree or certification in life sciences or regulatory affairs
Work EnvironmentManages teams across multiple regions, oversees global labeling strategies, and collaborates with regulatory agenciesFocuses on creating, reviewing, and updating labeling content within a specific project or region
Employer & Industry UsageCommonly employed by pharmaceutical and biotech companies in global regulatory operationsFound within pharmaceutical companies, focusing on labeling content and compliance

The Manager Global Labeling Operations oversees global labeling strategies and manages teams, while the Labeling Specialist handles the detailed creation and review of labeling content. The manager has broader responsibilities, including strategic planning and cross-regional coordination, whereas the specialist focuses on day-to-day labeling tasks within specific projects.

What are popular job titles related to Manager Global Labeling Operations jobs in Delaware?

For Manager Global Labeling Operations jobs in Delaware, the most frequently searched job titles are:

What job categories do people searching Manager Global Labeling Operations jobs in Delaware look for?

The top searched job categories for Manager Global Labeling Operations jobs in Delaware are:

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Cities in Delaware with the most Manager Global Labeling Operations job openings:

Manager Global Labeling Operations jobs near you
Infographic showing various Manager Global Labeling Operations job openings in Delaware as of August 2026, with employment types broken down into 66% Full Time, and 34% Contract. Highlights an 84% In-person, and 16% Remote job distribution.

Sr Manager, Regulatory Operations

Newark, DE • On-site

Hologic
Health Care and Social Assistance • 5 - 10K employees
Learn more about Hologicexternal

Full-time

Posted 21 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

Job description


Job Summary:
The Senior Manager, Regulatory Operations provides strategic and operational leadership to ensure compliant, efficient and scalable regulatory processes. This role is responsible for key regulatory operational areas including labeling, post-market regulatory reporting, state licensing and regulatory agency account maintenance, and Unique Device Identification (UDI) governance. This role ensures global compliance with regulatory requirements while enabling efficient, scalable processes that support a growing medical device portfolio. Provides counsel to and manages the regulatory team. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
Establishes operational objectives and work plans, and delegates assignments to subordinate managers. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect. Manages activities of two or more sections of departments. Exercises supervision in terms of costs, methods, and staffing. In some instances, this manager may have subordinate supervisors.
Essential Duties and Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
  • Serve as the Divisional labeling process owner and ensure compliance with global labeling requirements (FDA, EU, and other international regulations). Oversee end-to-end labeling processes, including development, review, approval, and lifecycle management of product labeling.
  • Establish and maintain labeling procedures, systems, and controls to ensure accuracy, consistency, and traceability and manage external vendors for translations. Partner with Quality and Commercial teams to support timely product launches, updates, and changes.
  • Lead regulatory post-market summary reporting activities including managing timely submission of reports to regulatory authorities (i.e., Periodic Safety Update Report, Health Canada summary report)
  • Manage regulatory establishment registrations and device listings, oversee US state licensing requirements and maintain regulatory data integrity within external databases including FURLS and Eudamed.
  • Serve as process owner for UDI compliance and governance across global markets. Oversee UDI data creation, validation, and submission to regulatory databases (e.g., GUDID, Eudamed).
  • Leads global standards management process and drives cross-functional collaboration with R&D, Quality, Clinical, and Manufacturing teams to identify, assess, and implement applicable international and regional medical device standards (e.g., ISO, IEC, FDA-recognized); ensures effective communication of requirements, alignment on compliance strategies, and integration of standards into product development and lifecycle processes
  • Develop, implement and maintain procedures and processes for regulatory operations
  • Responsible for planning, assigning, and directing work, performance management, facilitating employee development, mentoring and coaching to maximize engagement and productivity. Directs activities as well as sets goals and objectives for the Regulatory function.
  • Updates job knowledge by studying trends and developments in Regulatory and Quality.

Qualifications:
Education
  • Preferred Minimum Non-Technical Degree: BA/BS Degree
  • Preferred Minimum Technical/Advanced Degree: Master's Degree

Experience
  • Preferred Minimum Non-Technical Degree: 10+ Years
  • Preferred Minimum Technical/Advanced Degree: 7+ Years with Master's Degree, 5+ Years with PhD

Skills
  • Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, EU MDD/MDR regulations and relevant global regulations related to medical devices.
  • Strong knowledge in medical device labeling requirements and previous experience leading a labeling function preferred
  • Computer literate; able to use word processing, spreadsheet programs, databases.
  • Excellent ability to read, analyze and interpret professional journals, technical procedures, and government regulations.
  • Strong ability to effectively present information and respond to questions from senior management, function heads, managers, supervisors, and all levels of employees.
  • Excellent interpersonal skills to interact with all levels of the company, sometimes in an adversary role.
  • Demonstrated success in management role.
  • Ability to work effectively in a strongly matrixed team-oriented structure.
  • Excellent communication, interpersonal and relationship management skills
  • Experience in medical device, pharmaceutical or equivalent regulated industry
  • QA and/or RA certification is beneficial.

Ready to make a difference in women's health? Apply today and join our team of passionate innovators at Hologic!
Additional Info:
The annualized base salary range for this role is $145,000 to $241,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms, or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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