Regulatory

  • location: Lexington, MA
  • type: Permanent
  • salary: $168,000 - $252,000 per year

description

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Regulatory Labeling Strategy Team Lead (Director Level)

Skill Set

  • Candidate needs to have solid Labeling background
  • Strong Technical Skills
  • Strong Management skills
  • Hands on
  • $168,500 - $210,600 - $252,800

Job Description:

  • Helps to establishes and manage Shire Global Labeling function.
  • Provides 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, i.e., US and EU (CP, MRP, and DCP).
  • 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.
  • Provides expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance.
  • Helps to establishes and manage Shire Global Labeling function.
  • Provides 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, i.e., US and EU (CP, MRP, and DCP).
  • 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.
  • Provides expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance.

Responsibilities

45%of Responsibilities

  • Oversees the development of the US and EU label and the labeling process
  • 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 the Shire document management system

35% of Responsibilities

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

  • Assesses resources necessary to properly support US and EU labeling
  • 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 Shire business and products (liaising with Regulatory Intelligence colleagues as appropriate).
  • Develops and directs Shire'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 Shire employee awareness of, and adherence to, Shire Labeling processes via regulatory training. Design and deliver labeling training programs
  • Leads the Labeling Teams in the development of labeling. Prepares final proposed labeling for review by the Labeling Team and ELC prior to internal approval and/or submission to health authorities.
  • Drives the development of the labeling strategy and backup strategy for label negotiations.
  • Oversees the preparation of submission-ready labeling components; consults with affiliates on Health Authority communications regarding labeling

20% of 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 and 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 guidance 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

Key Skills, Abilities, and Competencies

  • Global experience is strongly desired.
  • Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
  • Excellent analytical, technical and problem-solving skills.
  • A self-starter who motivates, has tact, diplomacy, leadership skills and who has a flexible and positive approach.
  • Demonstrated leadership ability.
  • Ability to manage complex projects and timelines in a matrix team environment.
  • Strong attention to detail and accuracy is a must.
  • Ability to present information effectively to senior management, regulatory authorities, public groups and other departments.
  • Demonstrated ability to integrate planning efforts across departments to ensure organizational effectiveness.
  • Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships.
  • Demonstrated ability to proactively maximize relationships to enable successful collaboration.
  • Demonstrated ability to facilitate a beneficial resolution of conflict.
  • Ability to articulate a clear vision and help others understand their relationship between their roles, the roles of others and the overall goals of Shire.
  • Ability to articulate the reason behind organizational changes and demonstrate flexibility, energy and resilience throughout change efforts.
  • Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to work in diverse teams to optimize decision-making
  • Demonstrated ability to provide coaching and feedback to foster professional development while also supporting business goals.
  • Must have the ability to understand and interpret Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines. Familiarity with operational, financial, quality assurance, and human resource procedures and requirements.
  • Applicable knowledge of the drug development process.
  • Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
  • Strong interpersonal, managerial and organizational skills.
  • Ability to evaluate issues relating to interpretation of scientific and clinical data and devise strategies to develop and maintain labeling to deliver corporate goals for new and mature products.
  • Ability to establish and implement company policy.
  • Maintains knowledge of current regulation, guidance and enforcement and communicates changes within regulatory and to cross-functional teams.

Complexity and Problem Solving

  • Consistently works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors across functional areas of the business.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Requires good knowledge of the functional area, business strategies, and the company's goals.

Internal and External Contacts

Internal (within GRA)

  • Regulatory Affairs Leadership Team
  • All levels within Regulatory - especially Manager through Director levels

Internal (within Shire / Outside of GRA)

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