Senior Regulatory Labeling Manager Jobs

Project Management experience, experience managing individual and group projects of moderate complexity

Experience working in a Documentum-based document management system

Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends

Works with customer experience, human factors to create layouts with appropriate placement, meaning and tone

Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies

Manages the review and approval of core DHCP letters

Proven successful project management leadership skills

Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

Develop team members to increase business acumen and functional skills.

Bachelor's Degree and related Labeling experience

Master's Degree and 6-8 years of related Labeling experience

Experience working in medical device, pharmaceutical or FDA regulated industry

Conduct high level proof-reading capabilities.

Maintain current knowledge of U.S. FDA submission standards.

Normal office situation or remote.

Key responsibilities for this role include:

The minimum qualifications for this role are:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Strong interpersonal, project management, communication, negotiation and problem solving skills.

Represent GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products.

Serve as the labeling lead for all labeling related topics.

Present to GLC on CDS changes.

Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.

Contribute to the creation of high quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries

Education, Knowledge, Skills, & Abilities

Self-directed with excellent time management skills.

Responsible for measuring costs associated with each initiative as well as the management of the Product & Package Development budget.

Bachelor’s degree in Design, Visual Arts, Packaging or similar discipline is required. OTC packaging experience a benefit.

Manage routing process including feedback from clients and resolving issues, preflight projects, including review of proofs, color correction and production changes.

Manage complex projects and deliver innovative packaging solutions within the appropriate timelines.

Functional/Technical Knowledge, Skills and Abilities

Commitment to learn and stay abreast of global medical devices regulatory requirements.

Minimum 7 years' experience in related work experience

Experience with regulatory documentation is preferred

Excellent communication and interpersonal skills

Serve as company-wide labeling SME working with various workstreams to maintain compliant labeling needs.

Provide strategic project management insights on short and long term global regulatory projects

Must have medical device experience and knowledge (Class 1 and/or Class 2 a plus)

Bachelor's Degree with 3-5 years of regulatory experience or Master's degree/PhD with 2-3 years of regulatory experience

Supplying regulatory advice and updates to both internal and external stakeholders

Lead post approval submission amendments and yearly reporting for regulatory compliance

Develop new systems to continuously improve and drive change

Experience leading the management of projects/timelines and collaborating with team members

Advanced technical skills in best business practices for electronic regulatory document preparation and submission, and document and life cycle management systems

Expertise in the use of document management and eCTD publishing systems

Previous experience developing work instructions and generating SOP’s that are consistent with global regulatory requirements and company business practices

Proven ability to manage, streamline and collaborate to improve document preparation and management systems

Minimum of 5 years prior experience in a Regulatory Operations group within the industry, Pharmaceutical or Biotech Company preferred.

8+ years of program / project management experience

Manage a team of highly skilled program and project managers

Strong track of organizational management, budgeting, and resource management

Manage our multi million dollar budget from planning to monthly reporting in alignment with our quarterly forecast

Manage our vendors and negotiate contracts

A seasoned people manager with a passion for growing others

Creating and Maintaining SPLs for products in alignment with changing technical requirements.

Education: Bachelor's or Associate’s degree in a scientific discipline or English.

Req Title: Regulatory Affairs Specialist; Labeling

Client: A major pharma company

Work Address: 100 College Road West, 08540, Princeton, NJ

Supporting and prioritizing launch labeling components readiness for a successful launch.

Strong computer, organizational, and project management skills.

Contributes to the completion of all technical and operational activities for Labeling Operations projects through management of internal and external resources.

Manages complex processes across functions and interacts effectively with team members to ensure product labeling meets regulatory requirements.

Owns quality records such as CAPAs, Deviations, and Change Management related to labeling.

Strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents.

Evaluates the flow of projects through the artwork development process against established timelines and prioritizes activities based on changing requirements.

Must be capable of interfacing with executive level of management and health care professionals

Providing guidance, as required, on requirements

Demonstrating a broad knowledge of product development process

Knowledge of global medical device labeling regulations and standards (i.e. FDA, ISO 1485, EU MDR, etc.)

Additional qualifications that could help you succeed even further in this role include:

Providing leadership and direction to the Labeling team

Follows Global Labeling procedures and maintains relevant databases and document management systems for assigned products.

Manages compounds with a high degree of complexity from a labeling perspective.

Works with customer experience, packaging engineering, and branding, HF, and artwork center to create layout templates for use in HF studies.

5+ years of experience in global and/or local regulatory labeling within the pharmaceutical industry.

Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.

Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!

Knowledge of global regulatory requirements

Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

Responsible for regulatory compliance with pre- and post-approval filings and reporting requirements

Minimum 10+ years’ regulatory strategy background with experience in the MDS, AML, or MM space

Preferences include recent successful NDA experience, as well as experience within a matrix environment

Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.

Excellent project management, and critical thinking skills

Reviews domestic and/or international labeling for compliance to labeling requirements including content, format and regulatory submissions

10+ years of relevant experience

Advanced knowledge of the scientific principles of the drug development process

Advanced, broad knowledge of regulations pertaining to drug product labeling

Excellent oral and written and written communication skills