Director, Global CMC & Combination Product Regulatory
BioSpace
A leading biopharmaceutical company located in Troy, New York is seeking a Regulatory Affairs leader to oversee global regulatory strategies for drug/device portfolios. The ideal candidate will have significant experience in CMC, including leadership in regulatory submissions and compliance activities. This is a key managerial role requiring a strong background in regulatory affairs and a proven track record in the pharmaceutical industry, supplemented by a relevant academic qualification. #J-18808-Ljbffr BioSpace
$157.2k - $256.6k
As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology... .... Responsibilities Lead product development activities from... ...and development processes for combination products is a plus. Does this...RegulatoryWork at officeRemote workWorldwideRelocation package3 days per week$68.5k - $88.02k
...Job Summary Global Trade Compliance is responsible for the deployment of an effective... ...of regulations, provision of regulatory guidance, training and development, audit... ...external global partners to ensure that product data is correctly determined/collected,...RegulatoryTemporary workLocal areaImmediate startRemote workFlexible hours$78.7k - $150.6k
...highly motivated and experienced CMC Regulatory Sciences Specialist to join... ...and marketing applications globally. Prepare and oversee... ...regulatory submissions and product supply plans. Engage with regulatory... ...(MS or PhD). Equivalent combination of education and experience...RegulatoryShift work$172.2k - $286.9k
Overview Leads the Chemistry, Manufacturing, and Controls (CMC) & Combination Products (CP) Internal Medicine team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role involves...RegulatoryFor contractorsLocal areaWorldwide$78.7k - $150.6k
...highly motivated and experienced CMC Regulatory Sciences Specialist to join... ...and marketing applications globally. Prepare and oversee the... ...regulatory submissions and product supply plans. Engage with regulatory... ...). May consider equivalent combination of education and experience....RegulatoryLocal areaShift work$142.4k - $224.1k
Product Management Role As a Product Manager, you will be a key driver of value and viability within the product team. We are looking... ...‑matter experts to sustain momentum and enablement. Work with Global Customer Success to ensure best‑in‑class onboarding, support...Full timeFor contractorsWork experience placementRemote workRelocationVisa sponsorshipFlexible hoursShift work$147.8k - $241.2k
Overview The Associate Director, Corporate Counsel... ...Industrial Operations and Product Supply), providing... ...within this complex, global organization. As a member... ...international import and export regulatory matters — including... ..., or an equivalent combination of education and...RegulatoryContract workWork at office$85.6k - $149.4k
Senior Technical Product Manager, UpToDate Patient Solutions At Wolters Kluwer Health, the UpToDate suite helps millions of clinicians... ...of Patient products and tools, aligning with customer value, regulatory constraints, and platform and division‑level strategy....RegulatoryWork at office$150.03k - $224.25k
...Provides critical support in developing global regulatory strategy, planning and execution of... ...strategic options for assigned Otsuka products. Translates complex pertinent global... ...regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory...RegulatoryTemporary workWork at officeLocal areaFlexible hours$78.7k - $150.6k
...highly motivated and experienced CMC Regulatory Sciences Specialist to join... ...and marketing applications globally. Prepare and oversee the... ...regulatory submissions and product supply plans. Engage with... ...). May consider equivalent combination of education and experience....RegulatoryLocal areaShift work- ...Global Product Owner - Vice President The candidate will be part of the Global Alternative Investment Product Development team, with... ...and data teams to deliver scalable solutions. ~ Knowledge of regulatory and risk considerations in portfolio management. Preferred...RegulatoryDay shift
- Regeneron is seeking a highly motivated CMC Regulatory Sciences Specialist in Troy, NY. This role involves managing CMC regulatory strategies throughout clinical and commercial phases, ensuring compliance with regulatory requirements. The ideal candidate will have strong...Regulatory
$239.6k - $399.4k
...biopharmaceutical company is seeking an Executive Director of External Manufacturing in East Greenbush, NY. This role involves overseeing global drug product manufacturing operations through CMOs, ensuring compliance with regulatory standards while driving strategic...Regulatory- BioSpace is seeking an experienced CMC Regulatory Sciences Specialist to join their team in Troy, New York. The role involves managing regulatory strategies for chemistry, manufacturing, and controls across clinical and commercial phases, ensuring compliance with regulations...Regulatory
$126k - $178k
...patients live healthier and more productive lives, our Sales teams... ...impacts millions of people globally, yet it often remains under-... ...operational efficiency. This role combines strategic planning,... ...based on clinical evidence, FDA regulatory approvals, and market trends...RegulatoryWork experience placementWork at officeNight shift- Regeneron Pharmaceuticals, Inc is seeking a CMC Regulatory Sciences Specialist to manage regulatory strategies for clinical and commercial phases. The ideal candidate will demonstrate expertise in CMC regulatory requirements, technical writing, and project management....Regulatory
$137k - $235.75k
...talent for the role of Associate Director, Oncology Epidemiology . We... ...execute analyses across the product cycle. Conduct literature... ...date with the FDA and other Regulatory Agencies regarding regulatory... .... Experience working in a global environment is preferred....RegulatoryFull timeTemporary workLocal areaRemote work$152.7k - $294k
...Stakeholder Alignment & Adoption: Work across global business and technology teams to build... ..., or a related field. An equivalent combination of education and experience will also be... ...expertise in security strategy/architecture. Product Security Lifecycle: Experience with...Summer holidayFlexible hoursShift work$148.84k - $175.1k
...onchain platform — and with it, the future global financial system. To achieve our... ...communication mechanisms. Partner with Product and Engineering - Translate internal and... ...Familiarity with global compliance and regulatory frameworks in financial services and / or...RegulatoryLocal area$186.78k
Overview Curia Global Inc. (Albany, NY) seeks an Associate Director, Quality for its Albany, NY location. The position... ...the overall department productivity and efficiency Provide oversight... ...other documentation required by regulatory agencies, customers, or to support...RegulatoryFull timeFor subcontractor$90k - $130k
...transactions, IPO readiness, financial and regulatory reporting, sustainability reporting,... ...You will serve clients ranging from global industry leaders to high‑growth startups... ...highly collaborative environment, you’ll combine traditional accounting advisory skills with...RegulatoryPermanent employmentRemote work$126.3k - $241.2k
Associate Director of IT Operations (Infrastructure Architecture) The Associate Director... ..., including GxP, FDA and other global regulatory requirements. Maintain robust security... ...environment. May consider equivalent combination of education and experience. Level is...RegulatoryLocal area- ...We Are: Accenture is a leading global professional services company that helps the... ...transformation leveraging omni cloud, we combine world-class learning and talent?development... ...to industry specific requirements, regulatory considerations and enterprise scale operating...RegulatoryWork experience placementLive inWork at officeLocal area
$130.9k - $154k
...platform — and with it, the future global financial system. To... ...audit coverage of technology, products and information security... ...understanding of local global regulatory requirements as it pertains to... ...Audit Committee and Board of Directors. Validate the effectiveness...RegulatoryLocal area$148.84k - $198.45k
...in building the future. The Role Director II, SLED Capture & Proposal Management -... ...influence across sales, solutions engineering, product, and operational teams. The director... ...changes, funding drivers, and regulatory developments impact SLED opportunities....RegulatoryFull timeContract workTemporary workLocal areaRemote work$252.62k - $297.2k
...onchain platform — and with it, the future global financial system. To achieve our... ...supported. We are looking for a Compliance Product Data Lead to join our Compliance... ...transparency from the point of data generation to regulatory reporting. Drive the Data Roadmap:...RegulatoryLocal area- ...Vice President, Product Manager JPMorganChase Digital is seeking a Vice... ...while meeting governance, risk, and regulatory expectations. The ideal candidate combines strong product craft with domain... ...talents they bring to our global workforce are directly linked to...Regulatory
$368k
...governance, and help meet stringent regulatory compliance requirements.... ...We are seeking a visionary Global Sales Leader to spearhead our... ...mindset, partnering closely with Product Management, Engineering,... ..., and entrepreneurial Senior Director to lead our Global NDB Sales...RegulatoryWork experience placementWork at officeLocal areaRemote workWorldwideRelocation package- ...and review complex waterfall structures; Complete required regulatory forms to ensure the Fund complies with specific regulation requirements... ...input as to the continued training opportunities at a global-company level; Provide daily leadership across the team and...RegulatoryLocal area
$162.7k - $203.4k
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan, operating... ...partnering closely with R&D to shape Target Product Profiles and development plans. Develop... ...trial design, evidence generation, and regulatory strategy to optimize future market...RegulatoryTemporary workWorldwide
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