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... ...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...SuggestedMinimum wageTemporary workLocal areaImmediate startRemote workWorldwide$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$238k - $374k
...what is possible in order to bring life-changing therapies to 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 leaders...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
$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...SuggestedTemporary 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...
$137k - $215.27k
...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... ...follows: With some supervision, leads the execution of regulatory CMC...Minimum wageTemporary workLocal areaImmediate startRemote 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...
$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$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...- ...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...
- ...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 leadership...Local areaImmediate startWorldwide
- ...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...Local areaImmediate startWorldwide
- ...Plans associated with regulatory filings and real-time inspection... .... Support Global Expansion Activities as... ...opening presentation, Site Master File, SME list and... ...to support the SM CMC Compliance Team. uthor... ...Operating Procedures. Lead and assist with...Work experience placement
$150.03k - $224.25k
...critical support in developing global regulatory strategy, planning and... ...alignment with the Global Regulatory Lead. Translates complex pertinent... ...team (GRL, regional leads, CMC-RA, labeling, medical writing... ...an active role in leading change. Strategic Thinking & Problem...Temporary workWork at officeLocal areaFlexible hours$144.4k - $195.4k
...Overview: The Senior Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for... ...position reports to the Director of Regulatory Affairs CMC,... ...developmental programs. Helps to lead the interpretation of...Full timeTemporary workLocal areaFlexible hours$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- Akebia Therapeutics is seeking a Director of Regulatory Affairs - Labeling to lead the global labeling strategy across its portfolio. The position requires extensive experience in regulatory labeling and the ability to influence cross-functional teams while ensuring compliance...
$200k - $260k
A leading consulting firm in health strategy seeks a Senior Director of Regulatory Strategy Consulting in Boston. In this role, you will utilize your substantial regulatory experience to shape global strategies and lead cross-functional teams. The ideal candidate possesses...Flexible hours$211.85k - $317.78k
...' lives. This is what you will do: The Senior Regulatory Affairs Director (Sr RAD), Global Regulatory Strategy, leads the development and implementation of global regulatory... ...able to manage multiple projects and adapt to changing priorities. Up‑to‑date knowledge of new and...Hourly payTemporary workWork at officeFlexible hours3 days per week$196.7k - $353.4k
The role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first‑in‑class therapeutics and drive successful global development and...Permanent employment- 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...
$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$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 areaImmediate startRemote workWorldwide- Hemab Therapeutics is looking for a Director of Regulatory Affairs in Cambridge, MA. This role involves developing and executing regulatory strategies for global programs treating rare hematological disorders. The ideal candidate will have a distinguished background in...
- **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
$139.67k - $172.54k
...looking for a Manager, Regulatory Affairs CMC who will thrive in a... ...reports to the Sr. Director, Regulatory Affairs CMC... ...Strategy Implement global CMC strategy for assigned... ...CMC related issues. Lead CMC‑focused... ...requests. Evaluate change controls for CMC impact...Work at officeRelocationFlexible 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...$270k - $330k
Title:Senior Director, Global Regulatory Affairs, Oncology Company:Ipsen Biopharmaceuticals Inc. About Ipsen... ...associations where appropriate, and leads operational excellence initiatives... ...deliver more. Proven ability to lead change and communicate difficult messages effectively...Full timeTemporary workLocal areaWorldwideFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Site CMC Director | Regulatory Change Lead. Be the first to apply!
- site supervisor Boston, MA
- site manager Boston, MA
- site superintendent Boston, MA
- site agent Boston, MA
- site construction manager Boston, MA
- site director Boston, MA
- hvac site manager Boston, MA
- director global regulatory affairs Boston, MA
- regulatory project manager Boston, MA
- regulatory & compliance manager Boston, MA

