Posted to MedZilla on 5/29/2017


Takeda Pharmaceuticals

US-MA, Manager/Senior Manager Global Regulatory Affairs- Advertising and Promotion 1701056-MZ


 
 

OBJECTIVES:
  • Manage at least one US marketed oncology product and supports others as needed.
  • Independently provides regulatory guidance and expertise to Promotional Material Review Team (PMRT) on the assigned products(s) of responsibility and identifies regulatory requirements and data needed to ensure claims are appropriately supported for drug products.
  • During the developmental stage, responsible for providing promotional regulatory guidance for creation of product labeling (eg, US Prescribing Information and Patient Information)
  • Manage submissions including major launch campaigns (e.g. Office of Prescription Drug Promotion (OPDP) advisory submissions)). Lead PMRT/Executive Review Team (ERT) review of advisory comments and propose Regulatory strategy for negotiation and implementation. Mentor and provide guidance to junior regulatory personnel.
  • Provide regulatory support in FDA meeting preparation and interacts with the reviewing staff at FDA Office of Prescription Drug Promotion (OPDP). May interact with other levels as appropriate within OPDP. Assist and attend FDA meeting.

ACCOUNTABILITIES:

  • Collaborate with PMRT and execute major US and Global campaigns with some oversight from function head.
  • Execute regulatory activities and provide regulatory support on projects in accordance with applicable US regulations and guidelines. Ensure regulatory compliance of promotional materials generated for assigned products.
  • Be prepared to present to Senior Mgt. and/or present regulatory topics to cross-functional teams as requested.
  • Understand and interpret scientific data as it relates to regulatory requirements and strategy for product promotional claims and unbranded disease awareness activities..
  • Understand broad concepts within regulatory affairs and implications across organization; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies; demonstrates increasing independence.
  • Plan, execute and manage regulatory OPDP submissions for assigned products.
  • Manage other regulatory professionals as assigned. Able to guide and develop direct reports. Identifies and notifies manager of resource gaps for assigned product.
  • Continually review competitive materials and provide assessment to Commercial organization as requested.
  • Interact with FDA to urge enforcement activity as necessary.
  • Serve as the Regulatory representative on responsible product Press Release Working Groups
  • Assists in the review of licensing opportunities.
  • Other duties as assigned
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS/BSc or BA accepted, RA Masters degree or PharmD preferred
  • > 5 years industry inclusive of > 3 years regulatory or related experience.
  • Experience in reviewing, authoring, or managing components of regulatory submissions or promotion and advertising materials or related activities.
  • Knowledge of FDA regulations.
  • Understanding of scientific principles and regulatory/quality systems relevant to drug development.
  • Experience in reviewing, authoring, or managing components of regulatory submissions or promotion and advertising materials or related activities.
  • Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
  • Able to deal with issues of critical importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance.
  • Demonstrates problem-solving ability and generates alternative solutions prior to elevation of issues to Manager.
  • Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion including major global codes and regulations. Has a thorough knowledge of historical enforcement actions and is readily able to use this in negotiation.
  • Works well with others, especially within cross-functional teams and management of direct reports.
  • Models leaders at all levels daily. Able to bring working teams together for common objectives

LICENSES/CERTIFICATIONS:

  • None Required. Regulatory Affairs Certification (RAC) desirable.
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings, including overnight trips.
  • Requires approximately up to 20% travel.

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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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