Sr. Manager/ Associate Director GRA Marketed Products Growth and Emerging Markets Regulatory Lead

Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 16, 2023

Job Description:

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as an Associate Director GRA Marketed Products Growth and Emerging Markets Regulatory Lead

How you will contribute:

• Responsible for demonstrating Takeda leadership behaviors
• Defines, develops and leads Marketed Products GEM strategies to maximize regulatory success towards
• achievement of program objectives in collaboration with Global and Local teams
• Independently manages, plans and executes all aspects for the successful preparation, submission and
• Timely approval of investigational applications, market applications, variations, post approval reporting
• Obligations and general product life cycle management of assigned program
• Represents Takeda MPG GEM in Health Authority meetings and leads or supports preparation activities for
• Meetings with HA , as required . Interacts directly with HA and participates in agency meetings and may
• Facilitate, depending on experience, for assigned programs
• Works closely with functional areas throughout the company. Advises functional areas regarding content
• requirements for MPG GEM submissions, reviews documents from functional contributors for consistency
• and completeness
• Stays current with regulations / guidances in Growth and Emerging Markets for impact on drug develop ment plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance
• In coordination with local regulatory lead, provides strategic guidance / advice on regulatory trends, regulations and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs
• Provides regulatory expertise on Marketed Products GEM for multiple projects including at least one highly complex program, focused on non-clinical and clinical aspects of registration and / or post-marketing compliance and life cycle management
• Assures ongoing efforts towards fulfilment of international product approval conditions for late-stage programs
• Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; company's consultants and Business Partners
• Supports Access to Medicines initiatives to develop and implement innovative patient access strategies
• Evaluates new business development opportunities for Growth and Emerging Markets and / or participates on due diligence teams
• Mentors other team members, if required, to support scope of project work
  
  Willingness to travel to various meetings, including overnight trips
  
  Requires approximately 10-30 % travel
  
  Minimum Requirements/Qualifications:
  • Bachelor's degree in a scientific discipline; BA accepted based on experience. Advance degree preferred.
  • Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and/or post-marketing phases
  • 8 years of directly-related regulatory experience is desirable
  • Sound working knowledge of regulations and guidances governing drugs and biologics in development and life-cycle management for growth and emerging markets; and US and EU (relevant to role), including interaction with Health Authorities
  • Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
  • Able to demonstrate skill(s) in regulatory strategy such as understanding broad concepts within regultory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
  • Generally strong in working well with others and within global teams
  • Effective manager who is able to bring working teams together for common objectives
  • Experience managing relationships with CROs and/or contractors is also preferred
    
    What Takeda can offer you:
    • Comprehensive Healthcare: Medical, Dental, and Vision
    • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
    • Health & Wellness programs including onsite flu shots and health screenings
      • Generous time off for vacation and the option to purchase additional vacation days
      • Community Outreach Programs and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursement Base Salary Range: $124,600 to $178,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. 8-5-101 et seq
        
        EEO Statement
        
        Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
        
        Locations
        
        Massachusetts - Virtual
        
        Worker Type
        
        Employee
        Worker Sub-Type
        
        Regular
        Time Type
        
        Full time
        
        

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