CMC Regulatory Specialist, Post-Approval & Lifecycle
Medexus and Research Capital Corporation
Medexus Pharmaceuticals Inc. seeks a Senior Specialist, Regulatory CMC to manage CMC change controls and regulatory work across Canada and the United States. You will assess changes, determine reporting pathways, prepare post-approval submissions, and coordinate documentation with internal teams and external partners. You will lead multi‑project CMC changes, collaborate with QA, operations, labeling, and CDMOs, monitor FDA and Health Canada guidance, and ensure timely lifecycle management of the #J-18808-Ljbffr Medexus and Research Capital Corporation
Vacancy posted 20 hours ago
Similar jobs that could be interesting for youBased on the CMC Regulatory Specialist, Post-Approval & Lifecycle in New York, NY vacancy
$169.1k - $212.8k
...Summary The Associate Director, Regulatory Affairs - CMC will be responsible for... ..., to enable regulatory approval on the first review cycle.... ...annual reports. Leads global post-approval CMC regulatory strategy... ...regulatory leadership for lifecycle changes (e.g.,...SuggestedTemporary workWork at office- Iovance Biotherapeutics, Inc. is seeking a Regulatory Affairs CMC Associate II to coordinate submissions across products, manage planning, qc, and eCTD content for clinical and commercial applications worldwide. The role emphasizes accuracy, regulatory expertise, and collaboration...SuggestedRemote jobWorldwide
- ...valve. We are seeking a Principal Regulatory Affairs Specialist to lead and execute regulatory activities... ..., clinical investigation, approval, and lifecycle management of Anteris’ medical device... ...marking activities, product changes, and post-market regulatory requirements....SuggestedWork at officeLocal area
$100 per hour
Company Overview: Nexus CMC Advisors provides regulatory CMC strategy to emerging and lean pharmaceutical sponsors, with a focus on U.S. FDA submissions... ...of at least $1,000,000 per claim Accept a 12-month post-engagement non-solicitation and non-circumvention obligation...SuggestedHourly payFull timeContract workFor contractorsCasual workSecond jobRemote work- ...biotechnology company is seeking a Senior Regulatory Affairs Specialist to support regulatory compliance and... ...organization. Prepare, review, and approve CTDs and other regulatory submissions... ...compliance throughout the product lifecycle. Qualifications: Bachelor's degree with...Suggested
- United States Digital Space LLC in the United States is seeking a Permitting Specialist to navigate regulatory requirements, research permits, and coordinate with agencies to keep projects on schedule. You will prepare permit applications, liaise with local, state, and...Local area
- ...world-wide. As a Senior Clinical Regulatory Specialist at Iterative Health, you will play a... ...guidance and oversight throughout the study lifecycle, from start-up and site activation... .... Monitor regulatory timelines, approvals, expirations, and outstanding requirements...Temporary workWork at office2 days per week
Iterative Health
New York, NY9 days ago - ...Overview: We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs... ...standards, and facilitating the approval process for clinical trials and product... ...ensure compliance throughout the development lifecycle. Maintain up-to-date knowledge of...Contract workWork at office
Cedent Consulting
New York, NY2 days ago - ...world's health. From clinical trials to regulatory, consulting, and market access, every... ...excellence across clinical, submission, and post‑approval activities. Serving as a key regulatory... ..., and regulatory requirements. Support lifecycle management activities to ensure...Local area
Regulatory Jobs
New York, NY1 day ago $150k
...every step of the product development lifecycle and beyond. Come and work for an organization... ...development and execution of global regulatory strategies for medical devices, in... ...strategic guidance to support regulatory approvals, market access, and commercialization objectives...Local areaNorth American Science Associates, Inc.
New York, NY1 day ago$80k - $90k
...range of possible compensation at the time of posting. Position Summary The Regulatory Compliance Specialist (RCS) provides administrative, operational,... ...distribute Visual Compliance usage reports; approve new user requests; distribute training materials...Temporary workWork at officeLocal areaColumbia University in the City of New York
New York, NY5 days ago- ...Institute seeks a Contract Compliance Specialist. The Proposal Operations Specialist is... ...resolve contractual issues, obtain required approvals, and support timely contract execution... ...tool ~ Familiarity with contract lifecycle management (CLM) and e-signature platforms...Full timeContract workWork at officeRemote work
Uptime Institute
New York, NY4 days ago - Reference: BBBH117882_1791453404Quality & Regulatory SpecialistLocation: Greater New York... ...sector to recruit a Quality & Regulatory Specialist.This is a broad, hands on role covering... ...documentation and support QA/QC approval prior to product release.* Review third...
CSG Talent
New York, NY3 days ago $180k - $200k
...our compliance advisory and regulatory change function. You'll turn... ...entire customer and product lifecycle. Own compliance review of new... ...and/or bank partner product approval packages within the compliance... ...during development, pre- and post-launch, and via ongoing oversight...Full timeWork at officeRemote workHome office- ...are inspired to do their best work every day. Join us! What the Regulatory Affairs department does at the Worldwide Regulatory Affairs... ...evolving regulations. Their expertise drives the development and approval of innovative medical products, supports business development...Remote jobContract workLocal areaWorldwide
- ...Colombia, Chile, and Peru, and we’re hiring our first Senior Regulatory and Start Up Specialist (Senior RSS) in Argentina! As the Senior RSS on our... ...timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international...Contract workLocal areaRemote workFlexible hours
- Pierre Fabre Laboratories in the United States seeks a regulatory affairs and safety professional to manage product lifecycles, registrations and post‑market variations. You will coordinate with local and global teams, monitor evolving regulations, and support pharmacovigilance...Local area
$60k - $75k
...organization,we’dlove to have you on our team. Job Role The Regulatory Maintenance Specialist serves as the regulatory owner for the Bronx site,... ...Maintenance Specialist is responsible for managing IRB approvals and amendments, maintaining staff credentialing and delegation...For contractorsWork from homeFlexible hoursShift work- ...people truly believe in what they are doing! Join Neogen as a Regulatory Affairs Specialist - APAC and play a key role in enabling compliant product... .... Coordinate regulatory submissions, registrations, approvals, certifications, import documentation, and other activities...Work at officeLocal area
$106.5k - $117.5k
...across commercial contracting, regulatory compliance, and consumer... ...stakeholders on contract terms, approval processes, and company policies... ...to support the full contract lifecycle, from intake and review... ...admission in New York. No prior post-graduate legal experience is...Full timeContract workSummer workInternshipWork at office2 days per week$170k - $195k
...opportunity? We are seeking a highly skilled Associate Director, Regulatory Affairs to support and help drive regulatory success... ...Operations) to help secure and maintain regulatory approvals across the product lifecycle. Success requires a solid understanding of regulatory...Work experience placementShift workOpenkrill
New York, NY1 day ago- ## Product Stewardship and Regulatory Specialist - HealthcareApply: Hybrid: Wimington, Delaware: Full time: Posted 8 Days Ago: 250191WAt DuPont, our purpose is to empower the... ...stewardship excellence across the product lifecycle**Drive Process Excellence & Continuous Improvement...Full timeWorldwide
$200k - $225k
...ensuring adherence to ethical standards throughout the investment lifecycle. Responsibilities & Deliverables Conduct due diligence reviews... ...compliance matters including management incentive plan approvals, management‑fee offsets, and employee movements between Cerberus...$66.3k - $81.25k
...opportunity to join our team as a Research Regulatory Specialist. The Research Regulatory Specialist... ...will include pre- and post-activation responsibilities. You will... ...regulatory submissions and disseminate approvals. Maintaining updates to regulatory documents...Local area- ...Key Responsibilities This role supports Regulatory Issue Management and Axiom implementation by ensuring issues are tracked, documented... ...Implementation Ability to manage the end-to-end project lifecycle for Axiom initiatives, including planning, execution, and delivery...Full timeWork at office
Phyton Talent Advisors
New York, NY1 day ago - ...environment. Key Responsibilities Own the end-to-end review and approval of marketing and advertising materials, including pitch decks,... ...and filing of Form ADV, Form PF, and other required regulatory submissions. Monitor regulatory developments affecting private...Full time
Fernridge Group
New York, NY6 hours ago $75k - $90k
...Company’s products are sold in over 120 countries. The Regulatory Affairs Senior Specialist drives global product registrations across multiple... ...and project management processes throughout the product lifecycle to support timely market entry. Monitor regulatory updates...Full timeWork at officeLocal areaRemote workWorldwideInterparfums, Inc.
New York, NY2 days ago- ...services firm is looking for a Compliance Associate to join its regulatory compliance team. This is a broad-based role covering... ...securities transactions, conflicts, restricted securities, and related approvals. Oversee required continuing education, annual...Full time
Madison-Davis, LLC
New York, NY1 day ago $24k - $25.88k
...the M.P.T.C. Basic Peace Officer course (currently 162 hours)Must meet Transportation Safety Administration requirements for S.T.A. approval.Exemplary attendance and punctuality.Commendable customer service and communication skills.Good judgment, clear decision making,...Hourly payFor contractorsApprenticeshipWork at officeLocal areaMetropolitan Museum of Art
New York, NY5 days ago$150k - $175k
...analytics — with hands-on proficiency in Chainalysis — and the regulatory acumen to operate in a global, multi-jurisdictional... ...Collaborate with Onboarding, Sales, and Legal to ensure client lifecycle processes are compliant, efficient, and scalable.Transaction Investigations...Work at officeClear Street
New York, NY5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Regulatory Specialist, Post-Approval & Lifecycle. Be the first to apply!
Related searches
- regulatory officer New York, NY
- regulatory affairs specialist New York, NY
- aml compliance analyst New York, NY
- medicare compliance specialist New York, NY
- compliance analyst New York, NY
- information security compliance analyst New York, NY
- senior compliance analyst New York, NY
- regulatory specialist New York, NY
- bsa aml compliance officer New York, NY
- trade compliance specialist New York, NY