Director, Regulatory CMC - Global Site Lead (Hybrid)
Takeda Pharmaceuticals
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 over 10 years of experience in the biopharmaceutical industry, with deep knowledge of regulatory CMC relevant to drug development. Strong leadership and communication skills are essential for interfacing with internal teams and external partners while driving innovative regulatory strategies. #J-18808-Ljbffr Takeda
- Takeda in Boston is looking for a GRA CMC Product Lead to oversee regulatory CMC strategies and lead submissions for investigational, registration, and... ...expert knowledge of CMC regulations. This position offers a hybrid work model along with competitive compensation and...Suggested
- 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... ...automation to enhance efficiency. A hybrid work model is offered,...Website
$137k - $215.27k
...looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device... ...strategies and managing submissions. The position offers a hybrid work model, with a salary range of $137,000 to $215,270, encompassing...Suggested$212k - $333.19k
...to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations... ...and proactive implementation. Globally influences and serves as a key opinion... ...is currently classified as hybrid following Takeda's Hybrid and Remote...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwideNight shift$177k - $278.08k
...patients worldwide. The Director Regulatory Site CMC ensures efficient and... ...practical experience with global HA requirements, beyond EU/... ...How you will contribute: Lead site-specific post-approval... ...is currently classified as hybrid following Takeda's Hybrid and...WebsiteMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$177k - $278.08k
...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... ...position is currently classified as hybrid following Takeda's Hybrid and...Minimum wageTemporary workLocal areaImmediate startRemote workWorldwide$177k - $278.08k
...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... ...is currently classified as "hybrid" following Takeda's Hybrid and...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- Takeda in Boston is seeking an experienced professional to lead Regulatory CMC strategies and manage regulatory submissions. The candidate should... ...with regulatory requirements. This position offers a hybrid working arrangement and competitive benefits including salary...
$238k - $374k
...to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination... ..., China). How you will contribute: Leads and develops a team of regulatory leaders... ...position is currently classified as hybrid following Takeda's Hybrid and Remote...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$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... ...is currently classified as “hybrid” in accordance with Takeda’s...Minimum wageFull timeTemporary workLocal areaImmediate startRemote work$177k - $278.08k
...lasting impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory... ...the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. #LI...Minimum wageFull timeTemporary workLocal areaImmediate startRemote workWorldwide$212k - $333.19k
...impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of the global... ...the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. #LI...Minimum wageTemporary workLocal areaImmediate startRemote workWorldwide- ...GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative... ...regulatory leadership. The position allows for hybrid work arrangements, reflective of Alnylam's commitment...
- ...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...
$137k - $215.27k
...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... ...position is currently classified as hybrid following Takedas Hybrid and...Minimum wageFull timeTemporary workLocal areaImmediate startRemote workWorldwide- **Job Description**The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational... ...goals. This is a Boston based, hybrid position requiring 3 days/week... ...:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status...WebsiteSummer workRemote workFlexible hours2 days per week3 days per week
- ...How you will contribute: Leads and develops a team of regulatory leaders and subject matter experts; oversees global CMC regulatory strategy and key submissions/health authority interactions for a portfolio of small molecule and biologic products through Phase 2. Partners...
$113.85k - $189.75k
...Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for... ...with FDA expectations and global standards. Prepare and review... ...model This role is hybrid. You will be expected to be on-site regularly and collaborate...WebsiteFull timeLocal area$172k - $187k
...Description Regulatory Affairs... ...and Controls (CMC), plays a critical... ...across multiple sites. Our team is driven... ...Associate Director, Regulatory Affairs... ...Regulatory CMC Lead for a late-stage... ...with global regulatory standards... ...eligible for a hybrid workplace model...WebsiteWork at officeLocal area$160k - $196k
...Associate Director, Regulatory Operations Global Submission Management page is... ...our shared purpose: leading the fight against MASH... ...Strategy, CMC, Clinical, Labeling,... ...arrangements, including hybrid and remote options.Madrigal... ...through our site. *Please be aware that...WebsiteMinimum wageFull timeLocal areaRemote workFlexible hours$240k - $360k
Senior Director, Global Value & Access Strategy - povetacicept Vertex Pharmaceuticals... ..., reporting to the ED Kidney Lead, to join our dynamic team in... ...and 401(k). Work Arrangement Hybrid‑eligible: work remotely up to two days per week or on‑site five days per week, subject to...WebsiteRemote workFlexible hours2 days per week$148.5k - $214.5k
...Job title : CMC dossier leader ~ Location... ...within Sanofi R&D Global CMC Development... ...responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable... ...with agency, site inspections, or written... ...#LI-SA #vhd #LI-Hybrid Pursue progress...Website- 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...$177k - $278.08k
...Initial Therapeutics, Inc. is seeking a Director Global Regulatory Affairs in Boston. The successful... ...develop global regulatory strategies and lead complex projects within the Neuroscience... ...landscapes. The role offers a hybrid work model and a competitive salary range...$328k
...Description General Summary: The Executive Director, Global Medical Lead (GML), HEME is a critical leadership role in Global Medical... ..., 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this...WebsiteSummer workRemote workFlexible hours2 days per week$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products... ...with a strong focus on leading major submissions and ensuring... ...compliance. This position offers a hybrid work model and a competitive salary...$84.7k - $122.8k
Stantec is a leading global design firm that brings together a multidisciplinary team of professionals... ...impact to our communities. This is a hybrid role expected to be in the office... ...respond to RFI’s, review submittals, complete site visits and prepare field reports...WebsiteFull timeWork at officeLocal area$170k - $190k
...Partners (U.K.) Limited in Boston is seeking a Director in the Tax Compliance function. This role... ..., including income tax provisions and global initiatives such as OECD Pillar Two. The... ...fund knowledge. The position offers a hybrid working arrangement with an attractive compensation...Remote job$139.67k - $172.54k
...Therapeutics(R), Inc. is seeking a Manager for Regulatory Affairs CMC in Cambridge, MA. This role requires 5+... ...with cross-functional teams, lead regulatory projects, and implement CMC strategies. The position offers a hybrid work model and competitive compensation...
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