Senior Manager, Gra Global Compliance

at Takeda Pharmaceuticals in Boise, Idaho, United States

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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 a Senior Manager, GRA Global Compliance where you will provide leadership and expertise in the identification, creation, and execution of GRA Compliance initiatives to drive overall compliance and growth, within the Global function, while meeting Takeda corporate objectives. Responsible for partnering and driving compliance with Global Regulatory Leads for clinical (IND/CTA) and post clinical submissions (NDA/BLA/MAA). Support the implementation of GRA processes, systems, and procedures for GxP processes (i.e., change control, deviations/CAPAs, etc.) within the region/LOC ensuring execution and compliance. Provide GCP and GVP inspection/audit partnership related to Global Regulatory Affairs processes.

You will also partner with the Global Regulatory Leads on key Regulatory strategic initiatives and/or issues ensuring compliance with FDA and EMA. Partner effectively with cross functional teams (i.e., Clinical Operations, R&D Quality, GCP Compliance, Global Patient Safety & Effectiveness), in the proactive identification of key regulatory compliance issues with the ability to determine actionable project proposals and drive them to successful resolution.

As part of the Global Regulatory Affairs, Audits, Inspections and Compliance team, you will report to the Director Global Regulatory Affairs, Audits, Inspections and Compliance.

How you will contribute:

+ Align GRA initiatives and implementation strategies with relevant stakeholders within Global Regulatory Affairs

+ Drives compliance within GRA linked to the updating and maintenance of systems used for regulatory activities

+ Support/ monitor global regulatory compliance performance of GRL's (Global Regulatory Leads) for all therapeutic areas (i.e. neuroscience, oncology, gastrointestinal)

+ Develop strong partnerships with cross functional leadership within clinical operations and R&D quality

+ Collaborate and build relationships with Global Regulatory Leads for the development and implementation of global regulatory processes/systems.

+ Lead and engage in efforts to simplify and optimize business processes and platforms to drive growth and seek opportunities for automation of manual processes.

Minimum Requirements/Qualifications:

+ Bachelor's Degree in a science or business-related field.

+ 5+ years of experience in pharmaceutical industry, with 5 years in Regulatory Affairs, clinical trial management, research and development, quality assurance/compliance.

+ Familiarity with FDA and EMA Regulatory requirements for clinical trial approvals, product approval and lifecycle processes.

+ GCP experience highly preferred.

+ Ability to identify proactively and anticipate risk of non-compliance in a complex environment.

+ Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.

+ Able to manage both time and priority constraints and to manage multiple priorities simultaneously.

+ Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.

+ Willingness to travel to various meetings, including overnight trips.

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

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $130,200 - $186,000, 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.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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

USA - MA - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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