Regulatory Affairs Expert
1 month ago
We are seeking an experienced Regulatory Affairs expert to lead our CMC team in developing and executing regulatory strategies for assigned products. As a key member of our team, you will represent Takeda in Health Authority meetings and drive preparation activities for meetings with Health Authorities on CMC related matters.
Key Responsibilities:
- Develops, executes, and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy.
- Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters.
- Provides guidance to teams on administrative procedural topics while interacting with International Heath Authorities.
- Fosters constructive working relationships when interacting with internal and/or external colleagues.
Requirements:
- BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required.
- 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and/or devices experience.
- People leadership experience (3+ years) required.
Benefits:
- Estimated Salary: $169,400.00 - $266,200.00 per year.
- Takeda is proud to offer a comprehensive benefits package, including medical, dental, vision insurance, a 401(k) plan, and company match.
- New hires are eligible to accrue up to 120 hours of paid vacation.
About Us:
Takeda Pharmaceutical is a patient-focused company that inspires and empowers employees to grow through life-changing work. We foster an inclusive, collaborative workplace where our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
-
Regulatory Affairs Attorney
5 days ago
Lexington, Kentucky, United States Stoll Keenon Ogden PLLC Full timeRegulatory Affairs AttorneyAbout Us: Stoll Keenon Ogden PLLC is a leading law firm with expertise in utility and energy matters. Our team of experienced attorneys provides top-notch legal assistance to clients across the country.Job Overview: As a Regulatory Affairs Attorney, you will play a critical role in supporting our clients in navigating complex...
-
Global Regulatory Affairs CMC Director
4 weeks ago
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda Pharmaceutical is a patient-focused company that transforms patient care through novel specialty pharmaceuticals and best-in-class patient support programs. We foster an inclusive, collaborative work environment where teams are united by an unwavering commitment to delivering better health and a brighter future to people worldwide.This...
-
Global Regulatory Affairs Leadership Opportunity
4 weeks ago
Lexington, Kentucky, United States LDI Group Full timeWe are thrilled to partner with the LDI Group, a global leader in innovative product development and advancement, to source a Senior Director of Regulatory Affairs. Due to their exciting growth trajectory, this individual will join the leadership team at a pivotal time, spearheading a Global Regulatory function.The objective of this role is to establish a...
-
Regulatory Affairs CMC Director
4 weeks ago
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeJob Summary:Takeda Pharmaceutical is seeking a skilled Regulatory Affairs CMC Director to join our team in Lexington, MA. In this role, you will lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead.About the Role:You will independently develop and execute regulatory...
-
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeAbout the RoleAt Takeda Pharmaceutical, we are a forward-thinking organization that unlocks innovation and delivers life-changing therapies to patients worldwide. As a Senior Regulatory Affairs Leader, you will be responsible for developing and executing global regulatory strategies for assigned products in the area of Chemistry, Manufacturing, and Controls...
-
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeCompany OverviewTakeda Pharmaceutical is a world-class research and development organization committed to unlocking innovation and delivering transformative therapies to patients worldwide. Our company focuses on four therapeutic areas and other targeted investments, pushing the boundaries of what is possible in drug development.SalaryThe estimated base...
-
Regulatory Affairs Director
4 weeks ago
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda Pharmaceutical is a patient-focused company dedicated to delivering transformative therapies and best-in-class patient support programs. We are seeking an experienced Regulatory Affairs Director to lead our CMC strategy and contribute to the success of our global regulatory initiatives.Job ResponsibilitiesDevelop and execute regulatory...
-
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeAt Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Our team is committed 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,...
-
Medical Professional
2 weeks ago
Lexington, Kentucky, United States Department of Veterans Affairs Full timeOverviewThe Department of Veterans Affairs is seeking a dedicated Medical Professional to join our team. As a Clinical Coordinator, you will play a vital role in providing expert care to our nation's veterans.Located in Lexington, KY, this position offers a competitive salary range of $61,869 - $121,930 per year.
-
User Experience and Regulatory Design Expert
3 weeks ago
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeAbout Takeda">Takeda is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We focus on four therapeutic areas and other targeted investments to bring life-changing treatments to patients globally.">Role Overview">We are seeking a highly skilled User Experience and Regulatory Design Expert to...
-
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeJob SummaryWe are seeking a highly skilled User Experience and User Interface Designer to join our team at Takeda Pharmaceutical. As a Regulatory Compliant UX Designer for Medical Devices, you will be responsible for creating intuitive and compliant design solutions that meet the intricate nuances of medical device and combination product design.Key...
-
DoD Documentation Expert
1 week ago
Lexington, Kentucky, United States MAINSAIL Group Full time**Job Summary:** We are seeking a highly skilled Technical Writer to support the Kessel Run Division within the USAF Digital Directorate at Hanscom AFB, MA.About MAINSAIL GroupMAINSAIL Group is a Boston, MA and Washington, DC-based company providing specialized services to the Defense Department and Department of Veterans Affairs. We leverage our operational...
-
Digital Communications Expert
2 weeks ago
Lexington, Kentucky, United States Pro2Serve Full timeAbout ETAS Inc.ETAS Inc. is a wholly owned subsidiary of Pro2Serve, a leading provider of environmental, technical, and engineering services. Our team supports the energy, defense, and science markets through responsive, cost-effective execution of critical environmental, facilities and infrastructure, and nuclear defense and nonproliferation projects.Job...
-
Quality Assurance Director
5 days ago
Lexington, Kentucky, United States Kentucky Blood Center Inc Full timeAbout the PositionThe Vice President, Quality & Regulatory Affairs (VPQRA) at Kentucky Blood Center Inc is a key executive leadership role responsible for our Quality Assurance (QA) program and regulatory compliance activities.This position requires strong leadership and supervisory skills to direct the QA department and team. The selected individual must...
-
Clinical QA Specialist
6 days ago
Lexington, Kentucky, United States Beacon Hill Life Sciences - Boston Full timeJob SummaryWe are seeking an experienced Clinical QA Specialist to support the development of innovative oncology treatments. This role will involve ensuring quality and compliance with Good Clinical Practice (GCP), Pharmacovigilance (PV), internal policies, procedures, and best industry practices.About the RoleThis position will report to the Sr. Director...
-
Project Management Expert in Architecture
5 days ago
Lexington, Kentucky, United States GRW Engineers, Inc. Full timeProject Management Expert in ArchitectureWe are seeking an experienced Project Management Expert in Architecture to join our team at GRW Engineers, Inc. in Lexington, KY. In this role, you will oversee multiple projects from proposal to construction administration services, working closely with our architectural staff, mechanical, electrical, civil, and...
-
Banking Services Expert
2 weeks ago
Lexington, Kentucky, United States Central Bank & Trust Full timeJob Description: Banking Services ExpertWe are looking for a skilled and results-driven Banking Services Expert to join our team at Central Bank & Trust. As a key member of our banking services team, you will be responsible for delivering exceptional customer service, promoting bank products, and driving sales growth.About the PositionJob Overview:The...
-
Staff Pharmacist
1 week ago
Lexington, Kentucky, United States CVS Health Full timeJob DescriptionAs a Staff Pharmacist at CVS Health, you will have the opportunity to work in a dynamic community healthcare setting, leading with heart and displaying empathy and compassion for patients, customers, caregivers, and colleagues. You will be responsible for keeping your customers and patients healthy through adoption and management of patient...
-
Executive Leader in Quality and Compliance
5 days ago
Lexington, Kentucky, United States Kentucky Blood Center Inc Full timeJob OverviewWe are seeking a qualified candidate to fill this key executive leadership role as the Vice President, Quality & Regulatory Affairs (VPQRA) at Kentucky Blood Center Inc.This position is responsible for ensuring the quality of KBC products and services through auditing and monitoring processes, analysis of reports, and maintaining current...
-
Analytical Validation Expert in Gene Therapy
4 weeks ago
Lexington, Kentucky, United States Genezen Full timeUnlock a Career in Gene TherapyWe are seeking an experienced Analytical Validation Expert to join our team at Genezen, a pioneering gene therapy company. This is an exceptional opportunity for a skilled professional to contribute to the development of innovative treatments and make a meaningful impact on patients' lives.About Genezen:Genezen is a...