Senior manager global regulatory affairs
Katalyst Healthcares and Life Sciences
Job Description:
This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows:
This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows
Roles & Responsibilities:
This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows:
This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows
Roles & Responsibilities:
- With some supervision, leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
- RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
- Has a strong foundational understanding of global RA CMC regulations and guidelines and can apply this understanding to projects to enhance probability of regulatory success and regulatory compliance.
- bility to draw from precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions.
- Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
- With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid out by the GRA CMC Product/Device lead(s)
- Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges.
- With supervision, supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
- Interacts directly with international Health Authorities on administrative procedural topics, as required.
- Fosters constructive working relationships when interacting with internal and/or external colleagues.
- Evaluates change proposals for global regulatory impact with some supervision.
- s a RA CMC member, ensures and/or enhances regulatory compliance .
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 6+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA . Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
- nalyze issues with attention to detail.
- bility to assess alternative approaches.
- Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.
- ble to deal with issues of critical importance with some supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management.
- Understands who is responsible for different decisions and escalates as necessary
- pplies decisions taken by the company
- Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
- Intentionally promotes an inclusive culture
- pplies the given prioritization framework with limited support
- Excellent written and oral communication skills required.
- Exercises good judgement in elevating and communicating actual or potential issues to line management.
Vacancy posted 11 hours ago
Similar jobs that could be interesting for youBased on the Senior manager global regulatory affairs in Boston, MA vacancy
$150.03k - $224.25k
...Provides critical support in developing global regulatory strategy, planning and execution of... ...marketed prescription drug submissions and manages lifecycle activities for all assigned... ...with 2 years' experience in regulatory affairs or related areas (e.g., clinical development...SeniorTemporary workWork at officeLocal areaFlexible hoursOtsuka America Pharmaceutical Inc.
Boston, MA2 days ago$137k - $215.27k
...therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices... ...contribute: With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy...SeniorMinimum wageFull timeTemporary workLocal areaImmediate startRemote workWorldwideTakeda Pharmaceutical Company Ltd
Boston, MA8 days ago- ...Therapeutics, Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The... ...will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must...Senior
$211.85k - $317.78k
...patients' lives. This is what you will do: The Senior Regulatory Affairs Director (Sr RAD), Global Regulatory Strategy, leads the development and... ...alignment. Independently resolve complex issues and manage regulatory risks within project teams. Partner with...SeniorHourly payTemporary workWork at officeFlexible hours3 days per weekAstraZeneca
Boston, MA5 days ago- 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...Senior
- ...hr Summary of Position: The Senior Manager, Pharmacovigilance (PV)... ...implementation, and oversight of the global PV compliance program to... ...with applicable global regulatory requirements, industry standards... ...Clinical Safety, Regulatory Affairs, Quality Assurance, and external...SeniorLocal area
$212k - $333.19k
...patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be... ...functional stakeholders and senior management. Acts independently under the... ...understanding broad concepts within regulatory affairs and implications across the...SeniorMinimum wageFull timeTemporary workLocal areaRemote workWorldwideTakeda Pharmaceutical Company Ltd
Boston, MA1 day ago$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...Senior$196.7k - $353.4k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader... ...external to the company Demonstrated competence in employee management and development Knowledge of and broad experience with regulatory...SeniorPermanent employment$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... ...Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with...Senior$211.85k - $317.78k
Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately...SeniorHourly payTemporary workWork at office3 days per week$107.16k - $226.32k
...it is an investment in our people, our future, and what we stand for as a firm. KPMG is currently seeking a Manager / Senior Manager to join our Global Compliance Management Services practice. Responsibilities: Manage assigned global compliance engagements...SeniorLocal areaRemote workKPMG
Boston, MA2 days ago- Zevra Therapeutics, Inc. is seeking a Senior Director, Controller to oversee the company's global accounting operations. This leadership position is essential for... ...in the biopharma sector. Responsibilities include managing financial close processes, providing strategic...Senior
$137k - $165k
A global biotechnology firm in Boston is looking for a Senior Manager, Global Trade Compliance. This strategic leadership role is responsible for overseeing the company's export control program, aligning operations with international regulations, and managing compliance...Senior- ...Senior Regulatory Affairs Manager- REMOTEI'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission...Senior
Barrington James
Boston, MA2 days ago - ...focused on innovative therapies. About the Role : The Manager/Senior Manager, Regulatory Affairs — Advertising, Promotion & Labeling is responsible for... ...U.S. promotional regulatory strategy and related global initiatives. Responsibilities : Serve as the Regulatory...Senior
Discover International
Boston, MA1 day ago - ...Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for the management of global regulatory leads with product and disease state expertise for specific...SeniorImmediate start
$222k - $370k
...the development of appropriate regulatory strategies and execution for... ...Accountable to the Global Regulatory Strategy TG Head and... ...Advocate persuasively to senior leaders in GSK and in Health... ...Significant experience in regulatory affairs (10+ years) ~5 + years experience...SeniorLocal areaGlaxoSmithKline
Waltham, MA2 days ago- ...make miracles happen. So, let's be those people. As the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and... ..., advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line...SeniorWork experience placement
Sanofi
Cambridge, MA4 days ago $246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...SeniorFlexible hours$212k - $333.19k
...life-changing therapies to patients worldwide. The Senior Director Global Regulatory Affairs Neuroscience is responsible for developing innovative... ...project developments to project teams colleagues line management and key stakeholders for alignment and to ensure...SeniorMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$137k - $165k
Overview The Senior Manager, Global Trade Compliance - Export Compliance is a strategic leadership... ...awareness programs, and ensure adherence to regulatory requirements across all jurisdictions... ..., Legal, Treasury, Government Affairs to interpret and operationalize trade...SeniorFull timeTemporary workPart timeWork at officeLocal area- AstraZeneca is looking for a Global Safety Program Lead, Senior Director in Boston, MA. This role requires extensive leadership in safety strategy, managing a team of safety physicians and scientists while ensuring compliance with regulations. The ideal candidate should...Senior
$274k - $330k
Scorpion Therapeutics is seeking a Senior Director of Pharmacovigilance in Boston. This leadership role requires strategic oversight for global safety surveillance activities, compliance with regulations, and cross-functional collaboration. The ideal candidate will have...Senior- About the Role The Senior Manager, Regulatory Affairs Operations supports global regulatory submissions across Xenon’s development portfolio. This role handles submission operations, publishing strategy, and lifecycle management, partnering closely with Regulatory Program...SeniorTemporary workWork at officeWorldwide2 days per week
$144.4k - $195.4k
...Overview: The Senior Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for developmental programs. This role will play a critical part in shaping regulatory strategies for emerging and complex modalities...SeniorFull timeTemporary workLocal areaFlexible hoursAlnylam
Cambridge, MA3 days ago- ...Senior Director, Regulatory Affairs At Verastem Oncology, we're advancing innovation and addressing the... ...regulatory barriers, and identify and manage potential risks. Act as primary company... ...Develop, update and implement a global regulatory strategy which supports product...SeniorTemporary workFor contractorsWork at officeWeekday work
Verastem
Boston, MA1 day ago - ...time Inspection Readiness. Develop, manage and contribute to ongoing maturity of... ...Inspection Readiness Plans associated with regulatory filings and real-time inspection... ...evidence binders for inspections. Support Global Expansion Activities as they relate to inspection...SeniorWork experience placement
Katalyst Healthcares and Life Sciences
Boston, MA1 day ago - ...seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy... ...submission and approval. You will manage a small team of Regulatory Affairs... ...Develop and execute integrated global regulatory strategies to advance investigational...SeniorWork at officeLocal area3 days per week
- ...Join Takeda as Director, Global Regulatory Labeling Strategy where you... ...How you will contribute: Management of Labeling Cross-Functional... ...content. Interface with Senior Management Cross-Functional... ...including clinical, safety, medical affairs, and commercial, to ensure...Local areaImmediate startWorldwide
Takeda Pharmaceutical Company Ltd
Boston, MA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior manager global regulatory affairs. Be the first to apply!
Related searches
- regulatory manager Boston, MA
- senior regulatory manager Boston, MA
- manager regulatory affairs Boston, MA
- head compliance Boston, MA
- finance compliance manager Boston, MA
- regulatory cmc manager Boston, MA
- regulatory project manager Boston, MA
- compliance manager Boston, MA
- compliance project manager Boston, MA
- regulatory affairs director Boston, MA