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Director, Global Regulatory Affairs Labeling Lead

Boston, Massachusetts

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Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

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We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.

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Director, Global Regulatory Affairs Labeling Lead

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Job ID R0016141 Date posted 04/20/2021 Location Boston, Massachusetts; Lexington, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

OBJECTIVES: 

  • Responsible for operational oversight and leadership for Takeda Global Labeling (GL), including labeling vendors assigned to GL responsibilities and tasks.
  • Develops, implements, and oversees appropriate systems to ensure compliance with external regulatory labeling requirements and internal Takeda standards.
  • Is a leader both internally and externally, contributing to cross-functional initiatives and influencing the field as applicable.
  • Provides leadership and development for direct reports, including those that serve as global labeling leads responsible for the design and execution of global labeling strategies in collaboration with their regional counterparts.

ACCOUNTABILITIES: 

  • Plans and manages CCDS (creation, maintenance, distribution, tracking and implementation), US, and EU labeling processes in line with strategic priorities and compliance with government regulations/Takeda quality standards to ensure commercial product integrity
  • Establishes and manages relationships with labeling vendors to ensure the effective implementation of labeling processes to meet business needs and regulatory requirements.
  • Monitors Local Operating Company (LOC) compliance with labeling activities, takes corrective actions as needed
  • Manages preparation of the Pharmacovigilance Site Master File (PSMF) labeling sections, and inspection/audit activities
  • Participates with influence in or leads departmental and cross-functional task-forces and initiatives 
  • Identifies risks with mitigation plans and communicates with GL Head
  • Serves as a labeling resource to the Therapeutic Area Units, Marketed Products, and US/EU Labeling Operations as well as Local Operating Companies for labeling issues
  • Leads the development of new strategic and operational initiatives to improve the efficiency of Global Labeling, US and EU labeling operations
  • Monitors industry labeling trends and proposes actions as appropriate
  • Provides leadership to GL staff (including Takeda employees, vendors, and partners) in establishing roles/responsibilities and accountabilities across the labeling function(s).

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BSc Degree, preferred.  BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred
  • 10+ years of pharmaceutical industry experience.  This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience. 
  • Understanding of scientific principles and regulatory/quality systems relevant to drug development. 
  • Knowledge of global standards and regulations related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred). 
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Demonstrates problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions. 
  • Must work well with others and within global teams. 
  • Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identifies issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Responsible for demonstrating Takeda leadership behaviors.

PHYSICAL DEMANDS: 

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  • Carrying, handling and reaching for objects.
  • Ability to sit or stand for long periods of time while traveling.

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings, including overnight trips.
  • Requires approximately up to 10-30% travel.

Location and Salary Information:

  • Post Role Location(s)
  • Base Salary Range: $185,000.00  – $215,000.00 based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off
  • If candidate is not eligible for any benefits or other comp., those can be excluded

This posting is made in compliance with Colorado’s Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq

Locations

Boston, MA

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0016141
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