Top 427 Shire Jobs | SimplyHired

Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health
Takeda Pharmaceutical —Boston, MA
- $154,400 - $242,550 a year
- Full-time
- Remote
- Medicine
- 5 years
- Bachelor's degree
- Paid holidays
- Disability insurance
Associate Director, Clinical Operations Program Lead
Takeda Pharmaceutical —Boston, MA
- $154,400 - $242,550 a year
- Remote
- English
- Bachelor's degree
- Conflict management
- Paid holidays
- Disability insurance
Associate Director, Clinical Operations Program Lead
Takeda Pharmaceutical —Boston, MA
- $154,400 - $242,550 a year
- Full-time
- Remote
- English
- Bachelor's degree
- Conflict management
- Paid holidays
- Disability insurance
Maintenance Technician II - Night Shift
Takeda Pharmaceutical —Round Lake Beach, IL
- $19.81 - $31.10 an hour
- Overtime
- Microsoft Word
- Ability to walk for extended periods
- Mid-level
- Paid holidays
- Disability insurance
Senior Director, AIRx Biologics Discovery Lead
Takeda Pharmaceutical —Boston, MA
- $212,000 - $333,190 a year
- Full-time
- Hybrid work
- Laboratory experience
- 11+ years
- Doctor of Philosophy
- Paid holidays
- Disability insurance
Executive Director, AIRx Computational Chemistry
Takeda Pharmaceutical —Boston, MA
- $238,000 - $374,000 a year
- Full-time
- Hybrid work
- 11+ years
- Doctor of Philosophy
- Senior level
- Paid holidays
- Disability insurance
10d
Maintenance Lead, Night Shift
Takeda Pharmaceutical —Round Lake Beach, IL
- $28.99 - $45.53 an hour
- 12 hour shift
- Microsoft Word
- Ability to walk for extended periods
- High school diploma or GED
- Paid holidays
- Disability insurance
Associate Director, Global Regulatory Affairs - GI & Inflammation
Takeda Pharmaceutical —Boston, MA
- $154,400 - $242,550 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Doctor of Philosophy
- Senior level
- Paid holidays
- Disability insurance
Global Head - Small Molecule In Vitro Pharmacology (Automation)
Takeda Pharmaceutical —Boston, MA
- $212,000 - $333,190 a year
- Hybrid work
- 11+ years
- Analysis skills
- Continuous improvement
- Paid holidays
- Disability insurance
AIRx, Sr. Director, Nonclinical Safety Lead
Takeda Pharmaceutical —Boston, MA
- $212,000 - $333,190 a year
- Call employer
- Hybrid work
- 11+ years
- Business development experience
- Doctor of Philosophy
- Paid holidays
- Disability insurance
AIRx Director, Computational & AI Biologics Design Lead
Takeda Pharmaceutical —Boston, MA
- $177,000 - $278,080 a year
- Hybrid work
- Computer Science
- Doctor of Philosophy
- Mentoring
- Paid holidays
- Disability insurance
Associate Director, Global Regulatory Lead, Oncology
Takeda Pharmaceutical —Boston, MA
- $154,400 - $242,550 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Senior level
- Negotiation
- Paid holidays
- Disability insurance
Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product
Takeda Pharmaceutical —Boston, MA
- $238,000 - $374,000 a year
- Full-time
- Hybrid work
- 11+ years
- Doctor of Philosophy
- Senior level
- Paid holidays
- Disability insurance
Associate Director, Global Regulatory Affairs Marketed Products
Takeda Pharmaceutical —Boston, MA
- $154,400 - $242,550 a year
- Hybrid work
- 5 years
- Bachelor of Science
- Bachelor's degree
- Paid holidays
- Disability insurance
Director, Global Regulatory Lead - Oncology
Takeda Pharmaceutical —Boston, MA
- $177,000 - $278,080 a year
- Full-time
- Hybrid work
- 8 years
- Bachelor's degree
- Senior level
- Paid holidays
- Disability insurance
Manufacturing Technician III
Takeda Pharmaceutical —Round Lake Beach, IL
- $21.59 - $33.90 an hour
- Overtime
- Ability to walk for extended periods
- English
- Mid-level
- Paid holidays
- Disability insurance
11d
Senior Director, Global Regulatory Lead – Oncology
Takeda Pharmaceutical —Boston, MA
- $212,000 - $333,190 a year
- Full-time
- Hybrid work
- Bachelor of Science
- 8 years
- Doctor of Philosophy
- Paid holidays
- Disability insurance
Associate Director, US Advertising & Promotion Regulatory Review
Takeda Pharmaceutical —Boston, MA
- $154,400 - $242,550 a year
- Full-time
- Remote
- 3 years
- Bachelor's degree
- Doctor of Philosophy
- Paid holidays
- Disability insurance
5d
Director, Global Regulatory Lead, GI & Inflammation
Takeda Pharmaceutical —Boston, MA
- $177,000 - $278,080 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Doctor of Philosophy
- Senior level
- Paid holidays
- Disability insurance
Executive Director, AIRx Program Lead: Biologics
Takeda Pharmaceutical —Boston, MA
- $238,000 - $374,000 a year
- Hybrid work
- 11+ years
- Doctor of Philosophy
- Senior level
- Paid holidays
- Disability insurance

I want to receive the latest job alert for Shire

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

Shire jobs near

Clinical Lead Nurse jobs in Boston, MA

Director Of Regulatory Affairs jobs in Boston, MA

Safety Director jobs in Boston, MA

Associate Director jobs in Boston, MA

Senior Director jobs in Boston, MA

Executive Director jobs in Boston, MA

Lead Designer jobs in Boston, MA

Clinical Lead Nurse jobs in Arvada, CO

Clinical Lead Nurse jobs in Gulfport, MS

Clinical Laboratory Scientist jobs in Kaiser, CA

Nurse Practitioner jobs in Omaha, NE

Clinical Lead Nurse jobs in Saint James, MN

Clinical Lead Nurse jobs in Dallas, TX

Director Of Regulatory Affairs jobs in Centreville, VA

Director Of Regulatory Affairs jobs in Rockville, MD

Director Of Regulatory Affairs jobs in Eden Prairie, MN

Director Of Nursing jobs in Stockton, CA

Director Of Regulatory Affairs jobs in Phoenix, AZ

Veterans Affairs jobs in St. Louis, MO

Student Affairs jobs in Chicago, IL

Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health

Takeda Pharmaceutical -
Boston, MA

Apply Now

Job Details

Full-time
$154,400 - $242,550 a year

Benefits

Paid holidays
Disability insurance
Health insurance
Dental insurance
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching
Volunteer time off
Life insurance

Qualifications

FDA submissions
Doctor of Medicine
Medicine
Performance improvement leadership
Strategic management
5 years
Investigational new drug (IND) applications
Collaboration with product development teams
Policy & process development
Doctor of Pharmacy
Bachelor's degree
Operational risk mitigation
Compliance training programs
Doctor of Philosophy
Pharmaceutical company experience
Team training
Industry trends
Master of Science
Leading team collaboration initiatives
Regulatory submission editing and review
Biomedical regulatory compliance
Communication with regulatory authorities for clinical trials
Operational excellence initiatives
Senior level
Cross-functional team management
Communication skills
Project stakeholder communication
Professional development training
Cross-functional communication
Stakeholder management

Full Job Description

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’s Privacy Notice and 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

Job Description

Objective / Purpose

Provides strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our products across therapeutic areas and to ensure goals/objectives are met

Accountabilities

Responsible for developing and leading the global regulatory strategies for precision medicine and digital health efforts for assigned programs.
Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
Partner with local/regional regulatory representatives to lead and support lifecycle management regulatory activities for the digital health and precision medicine portfolio, including change impact assessments, regulatory strategy alignment, and execution of required maintenance submissions/notifications to ensure ongoing compliance across markets.
Ensures therapeutic asset’s global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategies
Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with management; understands probabilities of technical success for the solutions.
Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internal governance technical review committees, key global health authority meetings and with external partners.
Participates with influence in or leads departmental and cross-functional task-forces and initiatives.
Influence cross-functional colleagues within the therapeutic area, across GRA and across the enterprise.
Provide training to cross-functional teams to enhance their understanding of regulatory requirements and processes.
Helps implement a culture of continuous improvement to improve regulatory processes, and drive the adoption of innovation and best practices within the regulatory function.
Provide regulatory strategy support to diligence for licensing opportunities as appropriate, including regulatory input on the selection, governance, and ongoing management of device/diagnostic partners.
Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
Support external influencing activities by coordinating and contributing to regulatory/policy engagement efforts, including drafting and reviewing guidance comments and supporting trade association working groups.

Education & Competencies (Technical and Behavioral)

Bachelor’s Degree, scientific discipline strongly preferred
Advanced degree in a scientific discipline (PhD., M.D., PharmD, MS) strongly preferred
A minimum of 5 years of experience in regulatory affairs. Experience working with medical devices and/or diagnostics within the pharmaceutical industry strongly preferred.
Proven track record in developing and managing regulatory strategies for digital health products, and/or diagnostics, and precision medicine.
Expert knowledge of device development, registration and maintenance requirements with experience in championing innovation in technical areas.
Comprehensive understanding of biomarker strategies and implications for drug development.
Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (i.e., IND, SRDs, IDEs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements).
Understanding of scientific principles and device regulatory requirements relevant to global drug development and post-market support, including EU MDR and IVDR.
Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy.
Demonstrates strong verbal and written communication skills, with the ability to translate complex regulatory concepts into clear, stakeholder-tailored communication

Location: Remote within the US

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:

Massachusetts - Virtual

U.S. Base Salary Range:

$154,400.00 - $242,550.00

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

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

#LI-Remote

Apply Now

Refine Your Search

Shire jobs

Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health

Associate Director, Clinical Operations Program Lead

Associate Director, Clinical Operations Program Lead

Maintenance Technician II - Night Shift

Senior Director, AIRx Biologics Discovery Lead

Executive Director, AIRx Computational Chemistry

Maintenance Lead, Night Shift

Associate Director, Global Regulatory Affairs - GI & Inflammation

Global Head - Small Molecule In Vitro Pharmacology (Automation)

AIRx, Sr. Director, Nonclinical Safety Lead

AIRx Director, Computational & AI Biologics Design Lead

Associate Director, Global Regulatory Lead, Oncology

Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product

Associate Director, Global Regulatory Affairs Marketed Products

Director, Global Regulatory Lead - Oncology

Manufacturing Technician III

Senior Director, Global Regulatory Lead – Oncology

Associate Director, US Advertising & Promotion Regulatory Review

Director, Global Regulatory Lead, GI & Inflammation

Executive Director, AIRx Program Lead: Biologics

I want to receive the latest job alert for Shire

Related Searches

Explore jobs in more locations

Job Description

Locations

Worker Type

Worker Sub-Type

Time Type

Job Seeker Tools

Employer Tools

Browse

Stay Connected