Current jobs related to Senior Regulatory Affairs Director, Global CMC Strategy - Lexington, Kentucky - Takeda Pharmaceutical
-
Senior Director of CMC Strategy
3 weeks ago
Lexington, Kentucky, United States Kiniksa Pharmaceuticals Full timeJob Summary We are seeking a highly experienced and skilled Senior Director of CMC Strategy to join our team at Kiniksa Pharmaceuticals. The successful candidate will be responsible for establishing overall CMC development strategies and timelines for all programs, working closely with the Tech Ops Core Team leads and external partners. This is a senior...
-
Regulatory Affairs Manager
4 weeks ago
Lexington, Kentucky, United States Takeda Full timeJob Title: Manager, Global Regulatory Affairs CMC Submissions ManagementTakeda Development Center Americas, Inc. is seeking a highly skilled professional to join our team as a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA.Job Summary:We are looking for a seasoned regulatory affairs professional with expertise in CMC...
-
Regulatory Affairs Manager
4 weeks ago
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeJob Title: Manager, Global Regulatory Affairs CMC Submissions ManagementJob Summary:Takeda Development Center Americas, Inc. is seeking a highly skilled Manager, Global Regulatory Affairs CMC Submissions Management to join our team in Lexington, MA. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global...
-
Senior Director Regulatory Affairs Lead
4 weeks ago
Lexington, Kentucky, United States LDI Group Full timeCompany OverviewLDI Group is a global leader in innovative product development and advancement, present in over 90 territories. Our mission is to make the world a healthier place.We are seeking a Senior Director Regulatory Affairs to join our leadership team and head up a Global Regulatory function. This role will be responsible for ensuring a best-in-class...
-
Regulatory Affairs Manager
4 weeks ago
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeJob DescriptionTakeda Pharmaceutical is seeking a highly skilled Manager, Global Regulatory Affairs CMC Submissions Management to join our team in Lexington, MA.Key Responsibilities:Develop and maintain strong working relationships with the regulatory CMC team and cross-functional teams.Participate on and/or lead multifunctional teams to deliver high-quality...
-
Regulatory Affairs Manager
3 weeks ago
Lexington, Kentucky, United States Takeda Full timeAs a key member of the Takeda Development Center Americas, Inc. team, you will play a critical role in ensuring the successful submission of CMC dossiers for advanced therapies and biological compounds. Your expertise in global CMC regulations will be essential in developing and maintaining strong working relationships with the regulatory CMC team and...
-
Lexington, Kentucky, United States Takeda Pharmaceutical Company Ltd Full timeJob Summary:As a Senior Director in Analytical Development, you will lead efforts in developing scientific methods and technology, implementing evolving scientific technology, driving team objectives, and managing team performance in line with Pharmaceutical Sciences' strategy to deliver on program strategy and initiatives.Key Responsibilities:Conduct...
-
Senior Director of Analytical Development
2 weeks ago
Lexington, Kentucky, United States Takeda Pharmaceutical Company Ltd Full timeAs a key member of the Takeda Pharmaceutical Company Ltd team, the Associate Director of Analytical Development will play a pivotal role in driving the development of scientific methods and technology. This individual will lead efforts to implement evolving scientific technology, drive team objectives, and manage team performance in line with Pharmaceutical...
-
Senior Director of Analytical Development
2 weeks ago
Lexington, Kentucky, United States Takeda Pharmaceutical Company Ltd Full timeWe are seeking a highly skilled and experienced individual to fill the role of Associate Director, Analytical Development, Bioanalytics Late Stage. This position requires a strong background in analytical development, with expertise in developing and implementing scientific methods and technology. The successful candidate will have excellent leadership and...
-
Lexington, Kentucky, United States Takeda Pharmaceuticals Full timeJob Title: Associate Director, US Advertising and PromotionAt Takeda Pharmaceuticals, we are seeking an experienced Associate Director to join our US Advertising and Promotion team. As a key member of our regulatory affairs team, you will be responsible for providing strategic oversight and guidance on the development and implementation of promotional...
-
Regulatory Medical Writing Director
3 weeks ago
Lexington, Kentucky, United States AL Solutions Full timeJob Title: Director of Regulatory Medical WritingAL Solutions is seeking a highly motivated Director of Regulatory Medical Writing to lead our Oncology Regulatory team. As a key member of our team, you will be responsible for overseeing the development of pivotal documents required for regulatory submissions, ensuring the quality and accuracy of our...
-
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeJob SummaryAs a Senior Director in Analytical Development, you will lead efforts in developing scientific methods and technology, implementing evolving scientific technology, and driving team objectives to deliver on program strategy and initiatives. You will have expertise in benchmarking analytical development trends within industry and demonstrate an...
-
Lexington, Kentucky, United States BioSpace, Inc. Full timeJob Summary:We are seeking a highly skilled and experienced Associate Director to lead our Analytical Development and Bioanalytics team. The successful candidate will be responsible for developing and implementing scientific methods and technology, driving team objectives, and managing team performance.Key Responsibilities:Independently conduct technical...
-
Lexington, Kentucky, United States BioSpace, Inc. Full timeJob SummaryWe are seeking an experienced Associate Director to lead our Analytical Development team in Bioanalytics Late Stage. The successful candidate will have a strong background in analytical development, with expertise in benchmarking industry trends and regulatory guidelines.Key ResponsibilitiesLead the development of scientific methods and technology...
-
Lexington, Kentucky, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a Senior Scientist – Analytical Development Biologics Early Stage, you will lead efforts in the development of scientific methods, implement evolving scientific technology, and influence strategic planning within AD and...
-
Lexington, Kentucky, United States Takeda Full timeJob DescriptionWe are seeking a highly skilled and experienced Director, Medical Communications and Scientific Training to join our team at Takeda. This role will be based out of our Lexington, MA office and will be responsible for leading and executing innovative medical communications and scientific training strategies across various therapeutic areas,...
-
Senior IT Manufacturing Director
3 weeks ago
Lexington, Kentucky, United States Takeda Pharmaceuticals Full timeAbout the Role:The Senior IT Manufacturing Director will oversee and manage all services that enable applications and operations at the shopfloor level of manufacturing production lines.This leadership position requires a blend of technical expertise and strategic vision to drive efficiency, innovation, and alignment with business objectives.Key...
-
Head of Quality Strategy and Excellence
4 weeks ago
Lexington, Kentucky, United States Takeda Pharmaceuticals Full timeAbout the RoleWe are seeking a highly skilled and experienced Head of Quality Strategy and Excellence to join our team at Takeda Pharmaceuticals. As a key member of our OpU/Functional Quality leadership team, you will be responsible for promoting and driving innovative and transformative approaches within the organization aligned with the Enterprise Quality...
-
Senior Strategy Administrator
3 weeks ago
Lexington, Kentucky, United States MIT Lincoln Laboratory Full timeJob SummaryThe Senior Strategy Administrator role at MIT Lincoln Laboratory reports to the Senior Manager of Strategy and provides administrative and logistical support to the Contracting Services Department (CSD) in creating and executing CSD strategy. This involves comprehensive support for various crucial functions within the organization, including...
-
Pharmaceutical Director
4 weeks ago
Lexington, Kentucky, United States PROFLUENCE RECRUITMENT Full timeDirector of PharmacyProfluence Recruitment is seeking a highly skilled and experienced Director of Pharmacy to lead our pharmacy department. As a key member of our senior leadership team, you will be responsible for overseeing the daily operations of the pharmacy, ensuring compliance with regulatory requirements, and driving excellence in patient care.Key...
Senior Regulatory Affairs Director, Global CMC Strategy
2 months ago
Takeda Pharmaceutical is seeking a highly skilled and experienced Senior Regulatory Affairs Director to join our Global CMC Strategy team. As a key member of our team, you will be responsible for developing and executing regulatory CMC strategies for assigned products, ensuring compliance with global regulations and guidelines.
Key Responsibilities:- Develop and lead the execution of regulatory CMC strategies for assigned products, ensuring compliance with global regulations and guidelines.
- Collaborate with cross-functional teams, including Pharmaceutical Development, Production, and Quality Assurance, to ensure effective strategies are implemented and project execution is on target.
- Communicate and negotiate with Health Authorities directly and indirectly, applying CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Develop constructive relationships with internal and external colleagues, including Alliance Partners, and proactively communicate issues to key stakeholders.
- Review and provide regulatory CMC input and approvals as needed for technical protocols, reports, and other documentation to ensure alignment with global regulatory requirements and standards.
- Prepare and maintain relevant regulatory documentation, including technical regulatory strategy documents, storyboards, risk assessments, and other materials, and provide tactical regulatory guidance to product teams in line with global regulatory strategies.
- Support and/or lead assigned global regulatory submissions, including Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, and other submissions, through the product lifecycle.
- BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred.
- 8 years of overall biopharmaceutical/device industry experience with 5 years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
- Analyze issues with attention to detail.
- Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.
- Able to deal with issues of critical importance with minimal supervision.
- Demonstrates emerging leadership, problem-solving ability, flexibility, and values teamwork.
Takeda Pharmaceutical is a patient-focused company that inspires and empowers employees to grow through life-changing work. We are a global Top Employer, committed to equitable pay for all employees, and strive to be more transparent with our pay practices.
We offer a comprehensive benefits package, including 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.
