Director Regulatory Labeling Strategy 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

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;

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.

Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation

Knowledge of assigned therapeutic areas/disease areas is preferred

Regulatory Affairs Professional Certification preferred

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

Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership – Leveraging our collective expertise to connect people to products and services.

Maintains current knowledge of regulations and guidelines (FDA, ICH, and others as required).

5-10 years experience in regulatory CMC

Coordinate and lead the task of drafting responses to CMC-related questions from FDA or foreign health authorities.

Work with functional groups to provide timely responses to CMC questions from regulatory authorities.

Coordinates activities for meetings with FDA and other regulatory authorities.

Coordinates with cross-functional teams to define contributions to submissions.

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.

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!

Preparing submission plans and manage timelines for regulatory submissions

2+ years of regulatory experience in a biotech/pharma company, preferably in biologics

Knowledgeable in FDA and ICH guidelines

Knowledge of Good Clinical Practice and current Good Manufacturing Practices (GMP) preferred

Assisting in coordination and preparation for regulatory agency meetings and associated briefing document preparation,

Managing regulatory submission process, documentation, submission logs and archiving

Provides strategic guidance on global regulatory requirements to management and project teams

Detailed knowledge of FDA/EMA/ICH regulations and guidance for global drug development, preparation and management of IND/CTA/MAA/BLA/NDA applications

Regulatory experience and detailed knowledge outside the US (Japan and/or EU) is preferred

Manages preparation of all regulatory submissions (IND/CTA/MAA/BLA/NDA)

Master's degree preferred and 15+ years of related experience, OR

PhD and 12+ years of related experience OR

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.

Scientific background, Ph.D., M.D., PharmD. , MS or commensurate experience

Significant experience in regulatory affairs (at least 3-5 years)

Direct experience in developing strategy and leading teams through interactions with FDA.

Extensive experience in initiating and conducting successful interactions within FDA.

Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities

Provide strategic direction (and content input) on US Labeling

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

•Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.

Reports to labeling management in Regulatory Operations and Innovation.

•Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE,, etc.).

3) STRONG TECHNICAL KNOWLEDGE OF SYSTEMS/SOFTWARE: LIFT, ALiCE, Veeva Vault, TVT,

4. Experience and/or Familiarity with Structured Content is preferred

•May be responsible for managing projects, processes, or programs with manager oversight.