Global Site CMC Director | Regulatory Change Lead
Initial Therapeutics, Inc.
Takeda is seeking a Director Regulatory Site CMC in Boston, MA, to lead regulatory change management activities and ensure compliance with global HA requirements. The ideal candidate has over 10 years of biopharmaceutical/device industry experience and a strong understanding of regulatory strategy. This position promotes an agile approach in regulatory processes and encourages the use of automation to enhance efficiency. A hybrid work model is offered, complementing a robust compensation package and benefits for employees. #J-18808-Ljbffr Initial Therapeutics, Inc.
$177k - $278.08k
...possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...regulatory CMC strategy and leads the execution of regulatory CMC...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Therapeutics, Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle...Suggested
- ...possible in order to bring life‑changing therapies to patients... ...Role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...the regulatory CMC strategy and leads the execution of regulatory CMC...SuggestedFull timeLocal areaWorldwide
$238k - $374k
...of what is possible in order to bring life‑changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...Japan, China). How you will contribute: Leads and develops a team of regulatory leaders...SuggestedMinimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide- A leading biopharmaceutical company is seeking a Director of Regulatory CMC in Boston, MA. This key role involves managing post-approval change activities, ensuring compliance with global regulations, and leading efforts to standardize processes. Candidates should possess...Suggested
$137k - $215.27k
...possible in order to bring life-changing therapies to patients... ...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...follows: With some supervision, leads the execution of regulatory CMC...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- Takeda in Boston is looking for a GRA CMC Product Lead to oversee regulatory CMC strategies and lead submissions for investigational, registration, and post-approval processes. This role requires a strong background in biopharmaceuticals with 10+ years in the industry...
$137k - $215.27k
Initial Therapeutics, Inc. is looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device experience and a BS/BA degree in a scientific discipline. Responsibilities include executing regulatory...$142.5k - $256.5k
...The Role The Associate Director, Global Regulatory, CMC will be responsible for coordinating regulatory... ...to health authority guidelines Lead Regulatory CMC discussions and interactions... ...Perform assessment of manufacturing change controls Support development of...Permanent employmentWork at officeWork from home$142.5k - $256.5k
Overview The Associate Director, Global Regulatory, CMC will coordinate regulatory CMC activities for one or... ...to health authority guidelines. Lead Regulatory CMC discussions and interactions... ...Perform assessment of manufacturing change controls. Support development of...$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position...$177k - $278.08k
...possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and... ...strong practical experience with global HA requirements, beyond EU/US... ...How you will contribute: Lead site-specific post-approval change...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs,... ...is required, and immunology background is preferred. CMC experience is a plus. Responsibilities Develop and...
$145k - $207k
...Associate Director, CMC Regulatory Cambridge, MA The Opportunity: As part... ...will serve as CMC-regulatory lead for assigned projects. Develop and execute CMC global submission plans and... ...compliance topics, including change controls, deviations, and GMP...$345k
Job title: Head of Global CMC - Vaccines Research and Development Location... ...portfolio priorities You will lead and develop the Global CMC team across multiple sites and disciplines What we do: Develop... ...global production sites Ensure regulatory compliance and prepare...Contract workWorldwideFlexible hours$177k - $278.08k
...of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible... ...of Labeling Cross-Functional Teams ~ Leads Labeling cross-functional teams providing...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- A leading BioPharmaceutical company seeks a Senior Director, Global Regulatory Strategy, to lead regulatory efforts for early-stage products and ensure alignment with health authority expectations. The role demands extensive regulatory experience in the pharmaceutical...
$211.85k - $317.78k
Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location... ...spirit and autonomy of a leading biotech. You’ll join an energising and... ...Demonstrated ability to innovate, lead change, and solve critical regulatory science...Hourly payTemporary workWork at office3 days per week$177k - $278.08k
...boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for... ...Teams. ~ Defines, develops, and leads global strategies to maximize global regulatory...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$142.5k - $256.5k
Moderna Therapeutics in Norwood, Massachusetts, is seeking an Associate Director for Global Regulatory, CMC to coordinate regulatory activities for various products. This role involves developing global regulatory strategies, managing multiple projects in a fast-paced environment...$270k - $330k
Position Overview The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing... ...pricing & reimbursement considerations. Lead regulatory consultation strategy,... ...internally and externally. Capability to lead change and communicate difficult messages...Temporary workWorldwideFlexible hours$270k - $330k
The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic... ...associations where appropriate, and leads operational excellence initiatives within... ...deliver more.Proven ability to lead change and communicate difficult messages...Temporary workLocal areaWorldwideFlexible hours- **Job Description**The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational... ...across GRA.* Develop and implement change management plans, training,... ...:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status...Summer workRemote workFlexible hours2 days per week3 days per week
$177k - $278.08k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of... ...counterparts. Accountabilities: The Director will be responsible for complex... ...and maintained in line with changing regulatory and business needs and...Minimum wageFull timeTemporary workLocal areaRemote work$177k - $278.08k
...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed... ...impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$212k - $333.19k
...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed... ...impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of the global regulatory...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- Moderna Therapeutics in Norwood, MA is seeking a Regulatory CMC Lead to manage a team of CMC experts. This role involves overseeing regulatory strategies for a portfolio of products, ensuring compliance with health authority guidelines, and leading interactions with regulators...
$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure the success of innovative oncology therapies. The successful candidate...$159k - $195k
...Summary: The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies... ...Include: Lead CMC Regulatory execution for... ...commercial manufacturing changes Responsible for the coordination...Local area$92.48k - $160.29k
Role, Inc. is seeking a Global Fund Solutions Manager based in Boston, Massachusetts. This role is pivotal in leading transformation and optimization initiatives within fund administration teams. The ideal candidate will have over 7 years of experience in financial services...
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