Senior Manager, Regulatory Submissions & Publishing Operations
Xenon Pharmaceuticals Inc.
Xenon Pharmaceuticals Inc. is seeking a Senior Manager for Regulatory Affairs Operations at its Needham, MA office. This role involves supporting global regulatory submissions through effective collaboration with cross-functional teams. Ideal candidates will have over 8 years of regulatory documentation experience and 5 years in a management role within the pharma or biotech sector. Benefits include health insurance, a retirement savings program, and additional perks. The position offers a hybrid work environment requiring at least two onsite days weekly. #J-18808-Ljbffr
- ...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...OperationsSeniorTemporary workWork at officeWorldwide2 days per week
- ...JOB TITLE: Executive Director, Regulatory Operations and Submission Management DEPARTMENT: Regulatory Affairs REPORTS TO: Head of Regulatory... ...and tracking, document readiness and quality control, publishing, dispatch, archival, and submission lifecycle...Operations
$130k - $190k
...Manager/Senior Manager Regulatory Affairs – Advertising, Labeling, and Promotion Cambridge, MA Added 2/... ...including updates, reviews, approvals, and submissions. Ensure claims are truthful, non‑... ...in conjunction with regulatory operations. Ensure alignment with promotional...OperationsSenior- ...therapies. About the Role : The Manager/Senior Manager, Regulatory Affairs — Advertising, Promotion &... ...activities. Prepare and support submission of regulatory filings associated with... ..., Legal, Clinical, and Regulatory Operations teams on promotional strategy and...OperationsSenior
$136k - $170k
...related to Sarepta's Regulatory Information Management System (RIMS),... ...develop regulatory submissions for dispatch to health... ...authorities globally. The Senior Manager, RIM will... ...lead end-to-end publishing and submission... ...system enhancements Operate under medium to low...OperationsSeniorWork at office$154k - $182k
...Senior Manager, Regional Regulatory Lead-North America for Vaccines CSL Seqirus is a leading global vaccine... ...with stationed region commercial operations and GRA. Engaging with local... ...Module 1 documentation required for submission and supports response to health authority...OperationsSeniorLocal area3 days per week$146.96k - $210.1k
...critical support in developing global regulatory strategy, planning and execution of... ...investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned... ..., medical writing, regulatory operations, etc.) to develop global regulatory...OperationsSeniorTemporary workWork at officeLocal areaFlexible hours- ...Job Description: The Sr Manager for regulatory surveillance will support the regulatory surveillance... .... Supports inspection and submission readiness by tracking and reporting progress... ...s degree in a scientific discipline, operations research, operations management, or a...OperationsSenior
- ...seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US... ...execution—from IND through BLA submission and approval. You will manage a small team of Regulatory... ..., CMC, Biostatistics, Clinical Operations, Medical Affairs, and Commercial...OperationsSeniorWork at officeLocal area3 days per week
$270k - $330k
...Position Overview The Senior Director, Global Regulatory Affairs, Oncology is accountable... ..., and Commercial Operations and Global Regulatory Affairs... ...boards. Prepare and lead submissions such as PIP, scientific advice... .... Proven experience managing complex worldwide products...OperationsSeniorTemporary workWorldwideFlexible hours$270k - $330k
...The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing... ...Franchise, and Commercial Operations for assigned products and... ....Lead the preparation of submissions incl PIP, scientific... ...project team and senior management decision making.Be accountable...OperationsSeniorTemporary workLocal areaWorldwideFlexible hours- ...Summary of Position: The Senior Manager, Pharmacovigilance (PV) Compliance... ...with applicable global regulatory requirements, industry... ...cross-functionally with PV Operations, Clinical Safety, Regulatory... ...surveillance, and regulatory submission compliance, as applicable....OperationsSeniorLocal area
- ...Senior CMC Regulatory Submission Manager A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri... ...crossfunctional project teams to support the execution of operational activity, monitor adherence to the process,...Senior
$130k - $160k
...Merida Biosciences in Cambridge, MA is seeking a Manager for Regulatory Operations. This key role focuses on planning, execution, and lifecycle management of regulatory submissions across various programs. The ideal candidate should have at least 5 years of experience...Operations$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$154.4k - $242.55k
...Associate Director, Head of IMP Quality to lead quality operations for investigational medicinal products. You will... ...leading a team, reviewing clinical materials, managing quality issues, and supporting regulatory submissions. Ideal candidates have a relevant degree, proven...OperationsSenior$161k - $187k
...Sr. Manager/Associate Director, Regulatory Affairs Menlo Park, California... ...Position Summary The Senior Manager / Associate... ...preparation and submission of high-quality... ...thinking with strong operational execution in a fast... ...dossier planning, publishing, and electronic submissions...OperationsSeniorRemote workFlexible hours$113k - $142.43k
...you develop and expand your career!Senior Regulatory Medical WriterThe Senior... ...internal teams to lead, write, and manage completion of clinical regulatory... ...findings, and working with Regulatory Operations for publishing and submission.This role reports to the Executive...OperationsSeniorWork at officeRemote work- ...the company's editorial operations. Education... ...Harvard Ophthalmology, the Senior Communications... ...individual independently manages all aspects of the award... ...Tracks submission timeline and manage applications... ...with textbook production/publishing and knowledge of the process...OperationsSeniorTraineeshipFreelanceLocal area
- ...regulated environment. This role involves operating equipment, executing manufacturing... ..., talent development and organizational management. Facilitates implementation and execution... ...6-00402 Irvine, CA Validation Engineer, Senior Job Description We are seeking a highly...OperationsSeniorTemporary workSecond jobImmediate start
$136.38k - $190.94k
...Sr. Manager, Compliance The Sr. Manager, Compliance plays a critical... ...across Legal, Risk, HR, Operations, and IT to implement effective... ...Risk, and Procurement. Regulatory Monitoring and Advisory... ...Compliance (GRC) Committee and senior leadership. Utilize analytics...OperationsSeniorWork at officeLocal area$156k - $316.5k
...Position Description The Senior Director, Regulatory CMC is responsible for... ...strong emphasis on lifecycle management, change management, and... ...regulatory partner to Technical Operations, Quality, and Supply Chain... ...leading post-approval submissions, including supplements,...OperationsSeniorFull timeWork at officeFlexible hours3 days per week- ...generations. Description: The Senior Manager of Import Compliance is a self-starter... ...the compliance function, guide import operations, and collaborate with sourcing, logistics... ...with company import volumes and regulatory requirements. Manage duty audits, duty...OperationsSeniorContract workLocal area
$143k - $175k
...Initial Therapeutics, Inc. is seeking a Senior Lab Manager based in Waltham, MA. This role involves managing laboratory operations, ensuring equipment functionality, and overseeing EHS compliance. The ideal candidate has a Bachelor’s degree in life science, with over...OperationsSenior- ...Zevra Therapeutics, Inc. is seeking a Senior Director, Controller to oversee the company's global accounting operations. This leadership position is essential for ensuring... ...biopharma sector. Responsibilities include managing financial close processes, providing strategic...OperationsSenior
- ...Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase... ...clinical studies. This role includes driving global submission planning, coordination, and execution across multiple regions...SeniorFull timeRemote work
$160k - $196k
...Associate Director, Regulatory Operations Global Submission Management page is loaded## Associate Director, Regulatory Operations Global Submission Managementlocations... ...of regulatory operations systems (RIMS, EDMS, publishing platforms).* Demonstrated ability to lead complex...OperationsMinimum wageFull timeLocal areaRemote workFlexible hours$160k - $240k
...Rhythm Pharmaceuticals, Inc in Boston is seeking an experienced Regulatory Affairs Operations professional to manage regulatory operations activities and ensure compliance with internal and health authority standards. The ideal candidate will have over 8 years of experience...OperationsSenior$235k - $260k
...continuing to grow and build the foundational operations that enable our employees, and our... ...seeking an experienced and strategic Senior Director of Regulatory Affairs Advertising/Promotion to lead... ...communicate impact assessments Manage label negotiations and updates during...OperationsSeniorWork at office- ...Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...the development of robust and accurate submissions. Develops constructive... ...some supervision, plans, executes and manages regulatory submissions according to the...Senior
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