Director, Global Regulatory Affairs CMC - Hybrid Leader

Takeda Pharmaceuticals

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 and a significant focus on regulatory CMC. The ideal candidate will demonstrate leadership, strong analytical skills, and expert knowledge of CMC regulations. This position offers a hybrid work model along with competitive compensation and benefits. #J-18808-Ljbffr

Apply

Vacancy posted 10 hours ago

Similar jobs that could be interesting for youBased on the Director, Global Regulatory Affairs CMC - Hybrid Leader in Boston, MA vacancy

Director, Regulatory CMC - Global Site Lead (Hybrid)
...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
Takeda
Boston, MA
11 hours ago
Global Regulatory CMC Lead Senior Manager
$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
Initial Therapeutics, Inc.
Boston, MA
10 hours ago
Director, Global Regulatory Affairs CMC (Hiring Immediately)
$177k - $278.08k
...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy...
Suggested
Minimum wage
Temporary work
Local area
Immediate start
Remote work
Worldwide
Takeda Pharmaceutical Company Ltd
Cambridge, MA
2 days ago
Director, Global Regulatory Affairs CMC
$177k - $278.08k
...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... .... This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy...
Suggested
Minimum wage
Full time
Temporary work
Local area
Remote work
Worldwide
Takeda Pharmaceutical Company Ltd
Boston, MA
2 days ago
Executive Director, Global Regulatory Affairs CMC Early Development
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide... ...execution. Serve as an influential leader internally and externally, shaping... ...is currently classified as "hybrid" following Takeda's Hybrid and Remote...
Suggested
Remote work
Worldwide
Takeda
Cambridge, MA
1 day ago
Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product
$238k - $374k
...to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...interfaces. Serve as an influential leader internally and externally, shaping... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote...
Temporary work
Work at office
Local area
Remote work
Worldwide
JobRx, Inc.
Boston, MA
4 days ago
Senior Manager, Global Regulatory Affairs CMC (Hiring Immediately)
$137k - $215.27k
...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...This position is currently classified as hybrid following Takedas Hybrid and Remote Work policy...
Minimum wage
Full time
Temporary work
Local area
Immediate start
Remote work
Worldwide
Takeda Pharmaceutical Company Ltd
Boston, MA
2 days ago
Senior Director, Global Regulatory Affairs CMC
...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...
Initial Therapeutics, Inc.
Boston, MA
10 hours ago
Global Regulatory CMC Associate Director - Strategic Leader
$142.5k - $256.5k
...The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...
Permanent employment
Work at office
Work from home
Initial Therapeutics, Inc.
Norwood, MA
10 hours ago
CMC Regulatory Director - Global Strategy & Submissions
$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... ...regulatory compliance. This position offers a hybrid work model and a competitive salary ranging from...
JobRx, Inc.
Boston, MA
10 hours ago
Global Site CMC Director | Regulatory Change Lead
...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 1... ...automation to enhance efficiency. A hybrid work model is offered,...
Initial Therapeutics, Inc.
Boston, MA
1 day ago
Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Fact
$212k - $333.19k
...patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device... ...proactive implementation. Globally influences and serves as a key opinion leader and resource within Takeda... ...is currently classified as hybrid following Takeda's Hybrid and...
Minimum wage
Temporary work
Local area
Remote work
Worldwide
Night shift
Takeda Pharmaceutical
Cambridge, MA
9 hours ago
Global Privacy Compliance Director - Hybrid (3 days on-site)
...MP Training and Recruitment is seeking a Privacy Compliance Director to oversee global privacy compliance efforts. This role involves managing a... ...field, and at least 10 years of relevant experience. This is a hybrid position based in Newton, MA with responsibilities for...
MP Training and Recruitment
Newton, MA
10 hours ago
Global Regulatory Director, Neuroscience (Hybrid)
$177k - $278.08k
...Initial Therapeutics, Inc. is seeking a Director Global Regulatory Affairs in Boston. The successful candidate will develop global regulatory strategies... ...to navigate regulatory landscapes. The role offers a hybrid work model and a competitive salary range of $177,000 to...
Initial Therapeutics, Inc.
Boston, MA
10 hours ago
Global Market Access Leader US Payer Strategy (Hybrid)
$250k - $280k
...A global biopharmaceutical company is seeking a Global Market Access Director/Senior Director to execute US pricing and reimbursement strategies. The ideal candidate will... ...global pricing strategy. The role allows for hybrid working arrangements with an expected salary...
Taylor Strategy Partners
Boston, MA
1 day ago
Global CMC Regulatory Leader - Early Development
$238k - $374k
...JobRx, Inc. is seeking an Executive Director for Global Regulatory Affairs CMC Early Development based in Boston. The ideal candidate will provide strategic leadership, overseeing global CMC regulatory strategies for small molecules and biologics through Phase 2, and...
JobRx, Inc.
Boston, MA
1 day ago
Director, Global Tax Compliance — Hybrid (18 Remote)
$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
Harbourvest Partners (U.K.) Limited
Boston, MA
4 days ago
CMC Regulatory Affairs Manager - Hybrid, Impactful
$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
Akebia-Therapeutics-
Cambridge, MA
2 days ago
CMC Regulatory Affairs Manager - Hybrid & Impactful
$139.67k - $172.54k
Akebia Therapeutics(R), Inc. is seeking a Manager for Regulatory Affairs CMC in Cambridge, MA. This role requires 5+ years of experience in the... ...projects, and implement CMC strategies. The position offers a hybrid work model and competitive compensation ranging from $139,67...
Akebia Therapeutics(R), Inc.
Cambridge, MA
2 days ago
Executive Director Global Regulatory Affairs CMC - Device and Combination Products
...How you will contribute: Lead and develop a team of regulatory leaders and subject matter experts; oversee global regulatory strategy and major submissions for a... ...applicable global regulations. Represent Global Regulatory Affairs in senior governance and interactions with global...
Scorpion Therapeutics
Cambridge, MA
10 hours ago
Senior Director, Global Regulatory Lead - Oncology
$208.2k - $327.14k
...patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be... ...broad concepts within regulatory affairs and implications across the organization... ...to people around the world. #LI-Hybrid #LI-AA1 Takeda Compensation and Benefits...
Minimum wage
Full time
Temporary work
Local area
Worldwide
Takeda
Boston, MA
9 hours ago
Director, Global Regulatory Lead, GI & Inflammation
$177k - $278.08k
...develops and leads global strategies to maximize global regulatory success towards achievement... .... Is a leader both in the department... ...: The Director will be responsible... ...within regulatory affairs and implications across... ...currently classified as “hybrid” in accordance with...
Minimum wage
Full time
Temporary work
Local area
Remote work
Takeda Pharmaceutical Company Ltd
Boston, MA
2 days ago
CMC Regulatory Science Director - Global Submissions Lead
...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...
Moderna
Norwood, MA
10 hours ago
Director, Global CMC Regulatory Strategy
$196k - $240k
...A biotechnology firm in Waltham, MA, is seeking a Director of Regulatory Affairs – CMC. This strategic role includes leading global regulatory strategies and mentoring team members. Candidates should have 10+ years of experience in biotech/pharmaceutical industries and...
Dyne Tx
Waltham, MA
10 hours ago
Associate Director, Regulatory Affairs, CMC
$170.9k - $231.3k
...Associate Director, Regulatory Affairs, CMC The Associate Director, Regulatory Affairs... ...and implementing global CMC regulatory strategies... ...landscape. This position is hybrid and primarily located in our... ...About Alnylam: We are the leader in RNAi therapeutics – a revolutionary...
Full time
Temporary work
Work at office
Local area
Alnylam
Cambridge, MA
2 days ago
Director, Regulatory Site CMC
...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...with strong practical experience with global HA requirements, beyond EU/US. who has... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote...
Remote work
Worldwide
Takeda
Cambridge, MA
4 days ago
Director, Global Regulatory Affairs Process Excellence and Transformation
$196.8k - $295.2k
...Director, Global Regulatory Affairs Process Excellence & Transformation The Director, Global Regulatory... ...corporate goals. This is a Boston based, hybrid position requiring 3 days/week... ...Partner with governance forums and senior leaders to ensure process improvements...
Summer work
Remote work
Flexible hours
2 days per week
3 days per week
Ver-Tex
Boston, MA
3 days ago
CMC Regulatory Affairs Manager, Biologics - Hybrid
...BioSpace is looking for a Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) to prepare regulatory strategies for biologics. This role involves... ...industry and strong communication skills. A hybrid work schedule is offered, including 3 days on-site...
BioSpace, Inc.
Waltham, MA
2 days ago
Director, Regulatory Affairs - Global Regulatory Strategy
...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...
Monte Rosa Therapeutics, Inc
Boston, MA
2 days ago
Manager Regulatory Affairs, CMC
$139.67k - $172.54k
Manager Regulatory Affairs, CMC LinkedIn Twitter Email Message Share... ...engagement while supporting hybrid flexibility based on role and... ...position reports to the Sr. Director, Regulatory Affairs CMC.... ...Duties Strategy Implement global CMC strategy for assigned...
Full time
Work at office
Relocation
Flexible hours
Akebia Therapeutics
Cambridge, MA
7 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director, Global Regulatory Affairs CMC - Hybrid Leader. Be the first to apply!