Senior Director, Regulatory Affairs Global Labeling

Location
Cambridge, MA, United States
Posted
Oct 26, 2018
Ref
R-00978
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Senior Director, Regulatory Affairs Global Labeling

Company:
Ipsen Bioscience, Inc.

Job Description:

Senior Director, Regulatory Affairs Global Labeling

Purpose & Scope

The Senior Director of Regulatory Affairs Global Labeling is responsible for establishing and managing IPSEN Global Labeling function. This person will report to the Vice President of Regulatory Affairs, North America and will provide regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling. Ensures that there is Labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans. Formulates regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information. Provides expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidances.

This position will have global responsibility, providing oversight to other Regulatory personnel including regional labeling leads who are responsible for developing or managing labeling content and ensure consistency across product labels. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process. This position will liaise heavily with the Global Project Teams, Submission Teams, and Benefit:Risk Team.

Essential Job Responsibilities

Establishes IPSEN Global Labeling function

• Oversees the direction, management and implementation of the global labeling processes, templates, tools and systems to improve efficiency, productivity, quality and consistency across products and compliance tracking with regulatory labeling guidance

• Assesses resources necessary to properly support global processes. Global Labeling function budget planning, and goals settings

• Formulates and implements regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products

• Formulates and implements regulatory strategy for cross-functional labeling teams

• Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio.

• Maintains awareness of regulatory legislation pertaining to labeling, assessing and communicating impact on IPSEN business and products (liaising with Regulatory Intelligence colleagues as appropriate).

• Develops and directs IPSEN's labeling policy and standard development and interpretation of regulations

• Influences cross functional Labeling Teams to achieve successful development, regulatory approval, and implementation of labeling strategies

• Ensures IPSEN employee awareness of, and adherence to, IPSEN Labeling processes via regulatory training. Designs and delivers labeling training programs

• Ensures global labeling compliance with all changes related to safety via overseeing implementation of safety label changes

• Development of system to ensure packaging materials comply with current product labeling.

Management of IPSEN Global Labeling function

• Oversees Labeling Teams involved with the creation, review approval, dissemination and archival of Global (CCDSs) and regional labeling documents
• Manages and facilitates review of CCDSs and regional labeling via the Labeling Team and Executive Labeling Committee (ELC).
• Facilitates consensus among labeling teams and ELC and secures appropriate approvals on labeling decisions. Ensures stakeholder awareness of proposed and newly approved labeling changes
• Identifies and resolves conflicts/issues to reach labeling decisions
• Communicates CCDS updates and timelines for submission of revisions to Health Authorities
• Ensures compliant version control of product labeling and other related documentation within IPSEN document management system
• Oversees other Regulatory personnel including regional labeling leads who are responsible for developing or managing labeling content and ensure consistency across product labels.
• System owner for label specific systems and business lead for use of other systems (e.g. submission management) as it pertains to system requirements to manage labels.

Other responsibilities:
• Mentoring employees/consultants
• Interviewing, hiring and training employees/consultants
• Planning, assigning and directing work
• Setting objectives and appraising performance
• Managing performance assessments and career development activities

Education & Experience Requirements:
• Bachelor's degree in a scientific discipline or closely related field is required
• Minimum of 10-12 years of regulatory experience in the pharmaceutical/biotechnology industry
• Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling
• Expertise in developing Company Core Data Sheet
• Knowledge of global guidances relevant to labeling, drug development, and commercialization of prescription medicines
• Excellent knowledge of EU and US labeling requirements and guidance for legacy and PLR labels and ability to communicate and resolve issues during labeling reviews and conversations.
• Understanding of SPL format, requirements and guidance for legacy and PLR labels and ability to communicate and resolve issues during labeling reviews and conversations
• Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation

• Excellent oral and written communication skills

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.