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$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
...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... ...position is currently classified as hybrid following Takedas Hybrid and...SuggestedMinimum 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$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic... ...How you will contribute: Leads and develops a team of regulatory... ...is currently classified as "hybrid" following Takeda's Hybrid and Remote...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$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... ...is currently classified as “hybrid” following Takeda’s Hybrid and Remote...Minimum wageFull timeTemporary workWork at officeLocal areaRemote 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 regulatory... ...the world. This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy. #LI-...Minimum wageFull timeTemporary workLocal 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- Initial Therapeutics, Inc. is seeking a skilled regulatory CMC leader to manage a team at their Norwood, MA site. The ideal candidate will have over 10 years in the pharmaceutical or biotech industry, including 8 years in Regulatory CMC, overseeing submissions and regulatory...Website
$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 Takeda's 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
- ...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...
$154k - $182k
...Senior Manager, Regional Regulatory Lead-North America for... ...Seqirus is a leading global vaccine company, dedicated... ...our Quebec, Canada site. This is a hybrid position and is... ...You will report to the Director, Global Regulatory Lead... ...and Regulatory CMC. Proactively fosters...WebsiteLocal area3 days per week- ...Plans associated with regulatory filings and real-time inspection... .... Support Global Expansion Activities as... ...opening presentation, Site Master File, SME list and... ...needed to support the SM CMC Compliance Team.... ...Operating Procedures. Lead and assist with additional...WebsiteWork experience placement
$137.8k - $206.8k
...Compliance is responsible for leading quality assurance and compliance... ...and experience #LI-hybrid Pay Range: $137,800 - $... ...Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility... ...Information Vertex is a global biotechnology company that...WebsiteWork experience placementSummer workRemote workFlexible hours2 days per week$144.4k - $195.4k
...The Senior Manager, Regulatory Affairs CMC Development is responsible... ...of the global regulatory CMC strategy... ...position reports to the Director of Regulatory Affairs... ...This position is hybrid and will be primarily... ...programs. Helps to lead the interpretation of...WebsiteFull timeTemporary workLocal areaFlexible hours$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...- Title CMC Lead, Launch Product, Small Molecules Location Zurich, Switzerland... ...Pharmaceutical Sciences, Global Supply & Quality (GSQ), and... ...and external manufacturing sites, and Pharmaceutical Sciences... ..., manufacturing, the regulatory environment, life cycle management...WebsiteFull time
$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...$139.67k - $172.54k
...engagement while supporting hybrid flexibility based on... ...for a Manager, Regulatory Affairs CMC who will thrive in a... ...position reports to the Sr. Director, Regulatory Affairs... ...Strategy Implement global CMC strategy for... ...CMC related issues. Lead CMC‑focused regulatory...WebsiteWork at officeRelocationFlexible hours- ...selected candidate will lead a team of MS&T... ...operational leadership for the CMC execution and lifecycle... ...Operations, Quality Assurance, Regulatory and the Program Team.... ...external manufacturing sites, Manufacturing... ...management tools. This is a Hybrid role, in office 2 to 3...WebsiteWork at office2 days per week3 days per week
$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...$139.67k - $172.54k
Akebia Therapeutics is seeking a Manager, Regulatory Affairs CMC for their Cambridge, MA office. The role involves shaping regulatory strategy... ...in regulatory submissions to FDA and EMA. Akebia promotes a hybrid work environment supporting flexibility while encouraging collaboration...Work at office$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...$240k - $360k
...autoimmune disease of the kidney that can lead to end-stage-renal disease. IgAN is... ...(gMG). Vertex is seeking a Senior Director of Global Value & Access Strategy (GVAS) for... ...and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In...WebsiteFull timeSummer workRemote workWorldwideFlexible hours2 days per week- ...Senior Principal Scientist for Regulatory Affairs to oversee the development and execution of global regulatory strategies in the cardiovascular... ...as the Global Regulatory Lead, interacting with regulatory... ...and communication skills. A hybrid work model is applied for this...
- Axon is seeking a Strategic Travel Manager to oversee its global travel program in a hybrid role based in Boston, MA. You will negotiate contracts with travel vendors and streamline administrative processes using AI tools. This position requires 2-5 years of relevant experience...
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