Head of Global Regulatory Affairs Operations, Compliance & Process Excellence

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases.

The Head of Global Regulatory Affairs Operations, Compliance & Process Excellence is accountable for overseeing Global Regulatory Affairs Operations across the entire PDT BU portfolio of products.

As the Head of Global Regulatory Affairs Operations, Compliance & Process Excellence, you will:

• Play a key strategic role in supporting the Global RA business by overseeing all PDT regulatory submissions globally to ensure proper resourcing, planning and on-time execution from a project management and submission support perspective.
• Provide strategic leadership for end-to-end regulatory compliance and process efficiencies across the PDT organization.
• Drive and manage the strategic and collaborative relationship between PDT Global Regulatory Affairs and the Takeda R&D GRA Operations organization, as well as all contracts with 3rd party vendors (ICON, FREYR).
• Actively participate in the PDT BU Regulatory Affairs leadership team, providing input on key strategic, portfolio, human capital and financial decisions.

Dimensions and Aspects

• Technical/Functional Expertise
• Leadership
• Decision-making and Autonomy
• Interaction
• Innovation
• Complexity

Minimum Requirements/Qualifications:

• Bachelor's degree or related experience is required. Scientific or closely related field preferred.
• Project management qualification.
• 7-10 years of regulatory experience in the pharmaceutical/biotech industry.
• Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance and process are required.
• Knowledge and experience of industry standard Regulatory publishing and Information Management tools is desired.
• Generally, has at least 3 years of management level experience.

Additional Information

• Demonstrated leadership skills and ability to inspire colleagues.
• Extensive knowledge of global regulatory and compliance requirements.
• Ability to use precedent and previous experience to develop innovative and flexible approaches to ensure regulatory compliance.

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 "hybrid" following Takeda's Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location: Boston, MA

U.S. Base Salary Range: $208,200.00 - $327,140.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time