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Director Regulatory Global Labeling - United States  

Company managed [?] Still accepting applications

Posted on : 07 May 2017

Project Description

Description
  • Our company  is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. 
  • These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. 
  • Our company will continue to focus on advancing therapies that are the first or best of their kind.        
  • Our company’s Development Sciences group is responsible for everything from research and discovery to post-market clinical development. 
  • Development Sciences involves all bench and clinical research and the associated groups that support those endeavors. 
  • Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. 
  • Come join our team and make a meaningful impact on patients’ lives.       



SUMMARY
  •  The Director of Regulatory Global Labeling (REG-GL) is a strategic role leading the development of labeling for products worldwide. 
  • Responsibilities may include developing the strategy for labeling content for Target Product Profiles, Company Core Data Sheets, Prescribing Information, Patient Labeling, and Instructions for use. The incumbent will be responsible for regulatory compliant, competitive, and up-to-date labeling. 
  • The Director/Senior Director of REG-GL provides regulatory labeling leadership to the labeling team and cross functional teams where Reg labeling membership is required. Manage the strategic regulatory labeling health authority interactions labeling negotiations worldwide. 
  • The Director/Senior Director is responsible for ensuring the execution of global regulatory labeling are aligned with the global regulatory strategy and corporate goals. Oversees and mentors labeling professionals to achieve regulatory objectives.       



RESPONSIBILITIES
  • Providing regulatory strategic guidance and oversight of global labeling activities for company  commercial products and development products in the metabolism and endocrinology, cell and gene therapy other therapeutic areas as assigned.         
  • An active member on regulatory, development, and commercial teams supporting the strategy and identify requirements to ensure labeling claims support the regulatory plans and are in-line with corporate goals.         
  • Lead the labeling teams, which will include participants around the globe.         
  • Ensuring commercial product labeling is compliant with the worldwide regulations and company procedures.           
  • Create and lead the development of labeling processes at the company.
  • Present strategic global labeling issues to Regulatory Management and Executive Management on an ad-hoc/issue-driven basis for assigned projects/products.         
  • Provide strategic input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices, and align with global strategic labeling plan.         
  • Responsible for the development of labeling negotiations strategic plan for the assigned therapeutic area(s) and conduct health-authority reviews and label negotiations (in writing, phone or in person as needed). Lead US and EU labeling negotiations for the assigned products.  Guide/ support REG International for all labeling related HA negotiations and participate in labeling negotiation meetings or teleconferences with HAs, as needed.         
  • Oversight and leadership of the International labeling and compliance with CCDS, local requirements, business strategies, and overall quality.          
  • Lead or direct the creation of high quality documents supporting changes to the CCDS or local labeling with internal and/or external experts including responses to labeling-related Health Authority queries.  Review of summary documents such as clinical overviews to ensure the labeling message is consistent with the overall representation of a marketing application.         
  • Present and defend proposed labeling changes in global product information documents, including labeling documents in key markets to Senior Management as required for review and approval.         
  • Interactions with RA worldwide: Interact with Regulatory International and regional Partners to ensure timely implementation of global labeling changes and new market submissions and approvals.         
  • Guide launch teams on launch strategy for new commercial products.  Provide Supply Chain and QA guidance on labeling implementation requirements.         
  • Ensure all labeling documents are of the highest quality and represent the safe and effective use of the product.         



Required Skills:
 A minimum of 12 years required of industry experience and extensive experience (at least 4-6 years) in global labeling, alternatively extensive experience in related areas of the Pharmaceutical Industry or Health Authorities.       
  • Experienced leader with management and direct reports.           
  • Experience negotiating with internal and external stakeholders on complex regulatory issues of importance to the company.
  • Seasoned regulatory professional with experience in submissions for products in development and commercial products.           
  •  Thorough understanding of regulatory labeling requirements and strategic labeling planning.           
  •  Outstanding interpersonal and communication (written and verbal) skills.           
  •  Attention to detail and highly organized.           
  • Prior experience leading cross functional teams.           
  • History of solving regulatory labeling related problems while exhibiting superior judgment and a balanced, realistic understanding of issues.           
  • Fluency in English as business language, additional languages advantageous.           


Desired Skills:
  • Expertise in global labeling and managing project teams including international teams (not in the same time-zone).           
  • Biologics and rare disease experience is desirable.           
  • US and/or EU labeling expertise required and International and Core Labeling experience preferred.           


EDUCATION
  • Minimum requirements Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.           


SUPERVISOR RESPONSIBILITY
  •   This position will have supervisory role with direct report(s).           


Equal opportunity :
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.