Senior Manager, GRA Marketed Products

Takeda; Boston (MA); Hybrid; USD 137,000 - 215,000; Full time

Job summary

Takeda Development Center Americas, Inc. seeks a Senior Manager, GRA Marketed Products to lead the Global Regulatory Team and drive global regulatory strategy across marketed products.

The role collaborates across functions to ensure timely FDA submissions and successful approvals, with up to 80% remote work. The position requires a Bachelor’s degree in Pharmacy or related field and at least 6 years of healthcare regulatory experience, with strong expertise in FDA, EU, and Health Canada

Qualifications

• Bachelor’s degree in Pharmacy or related field, plus 6 years of healthcare regulatory experience.
• Experience applying FDA, EU and Health Canada regulations to design regulatory strategies.
• Ability to lead regulatory strategies and manage global submissions.
• Experience leading HA meetings and negotiations during reviews.

Responsibilities

• Lead the Global Regulatory Team (GRT) and sub-working groups such as Label Working Group.
• Define strategies and provide tactical guidance to teams; collaborate cross-functionally.
• Responsible for US FDA submissions and approvals; serve as point of contact with FDA.
• Coordinate with regulatory regional leads, other functions, and vendors for global submissions.
• Monitor regulatory trends to strengthen product development plans.

Skills

Regulatory leadership

FDA interactions

Regulatory strategy

Global regulatory

Stakeholder management

Education

Bachelor's degree in Pharmacy or related field

Job description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

Job Description

JOB LOCATION: Cambridge, MA

POSITION: Senior Manager, GRA Marketed Products

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Senior Manager, GRA Marketed Products with the following duties: lead the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represent GRT at project team meetings; define strategies and provide tactical guidance to teams and collaborate cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance; apprise project team colleagues, line management, and key stakeholders of developments that may impact regulatory success; responsible for developing solutions to identified risks and discussing with team and management and understand probabilities of technical success for the solutions; be accountable for all US FDA submissions and approvals of project(s) of responsibility; serve as direct point of contact with FDA, lead and manage FDA meetings; be accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products; oversee vendor responsibility for regulatory activities and submissions related to projects within scope; lead regulatory reviewer in due diligence for licensing opportunities; partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable; monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plans and adopt regulatory strategies in a timely manner. Up to 80% remote work allowed.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered will be in accordance w/ state or local min wage requirements for the job location.

US based employees may be eligible for short-term &/or long-term incentives. US based employees may be eligible to participate in medical, dental, vision insurance, 401(k) plan & company match, short-term & long-term disability coverage, basic life insurance, tuition reimbursement program, paid volunteer time off, company holidays, & well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, & new hires are eligible to accrue up to 120 hours of paid vacation.

REQUIREMENTS: Bachelor’s degree in Pharmacy or related field, plus 6 years of experience in the healthcare regulatory industry. Prior experience must include: apply FDA, EU and Health Canada regulations to design and execute regulatory strategies to maintain registration and ensure global regulatory compliance; plan and manage global regulatory submissions considering company’s goals, procedural timelines and regulations for life cycle management; lead development and execution of regulatory strategies, lead HA meetings and negotiations during review; manage the authoring, review cycles, finalization, and submission of regulatory submissions to the US and EU.

Full time. $137,000 - $215,270 per year.

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

EOE