Global CMC Regulatory Strategist: Submissions & Strategy
Regeneron Pharmaceuticals, Inc
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. This role requires a strong background with at least 5 years of experience in regulatory submission for biopharmaceuticals, along with a BS/BA in a scientific discipline. The position offers a competitive salary, benefits including health programs, and a collaborative working environment in Troy, New York. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc
$146.96k - $210.1k
A global healthcare company is seeking an experienced regulatory affairs professional in Albany, NY. The role requires expertise in developing global regulatory strategies, executing submissions, and managing lifecycle activities. The ideal candidate has a strong background...Regulatory$157.2k - $256.6k
...Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide... ...portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory...RegulatoryWork at officeRemote workWorldwideRelocation package3 days per week$78.7k - $150.6k
...highly motivated and experienced CMC Regulatory Sciences Specialist to join our... ..., and Controls (CMC) regulatory strategies across clinical and commercial phases... ..., amendments, commercial submissions, and marketing applications globally. Prepare and oversee coordination...RegulatoryShift work$100 - $150 per hour
Regulatory Strategist and Advisor - China Market, Client/Sponsor -Facing Location... ...will shape regulatory strategy, inform clinical trial design... ...‑specific interactions and submissions. The role is client‑facing... ...differences across key global regions, including comparisons...RegulatoryHourly payContract workPart timeLocal areaRemote work- Katalyst CRO, located in Albany, NY, is looking for a Regulatory Associate to support regulatory documentation for clinical trials and... ...This position provides an opportunity to work with cross-functional teams to drive regulatory strategies. #J-18808-Ljbffr Katalyst CRORegulatoryWork at office
$100 - $150 per hour
Eliassen Group is seeking a part‑time Regulatory Strategist for the China market. The role, which can be performed remotely, requires experts... ...development. Responsibilities include providing regulatory strategy, engaging with clients, and supporting internal teams....RegulatoryRemote jobHourly payPart time- ...A leading biotechnology company in Troy, NY, seeks an Associate Director to develop global CMC regulatory strategies for hematology and oncology portfolios. Responsibilities include leading regulatory activities, mentoring staff, and guiding interactions with regulatory...RegulatoryRelocation package
$100k - $120k
...Marsh & McLennan Companies is looking for a Senior Consultant to join their Brand Strategy team in Albany, New York. You will be responsible for solving complex brand issues for clients through strategic and creative approaches, conducting research, and collaborating...- Siemens is looking for a seasoned professional to lead the PR and social media strategy at Mendix in Albany, NY. This role focuses on driving global PR initiatives, developing thought leadership messaging, and enhancing brand recognition through media engagement. The ideal...
- ...will have a Bachelor's degree in engineering or science, with extensive experience in nuclear technologies. Responsibilities include analyzing complex nuclear issues, coordinating state activities, and ensuring public health and regulatory compliance. #J-18808-Ljbffr...Regulatory
$74.7k - $187k
...meet the unique business, operational, and regulatory requirements of the U.S. healthcare... ...leverage this expertise to help shape product strategy, prioritize roadmap investments, and... ...to play a key role in bringing a proven global healthcare platform to the U.S. market and...RegulatoryTemporary workFlexible hours$249.97k - $388.13k
...Summary: The Executive Director, Global Value Evidence Lead, is a strategic... ...driving the global value evidence strategy across the company's portfolio. This... ...generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate the differentiated...RegulatoryTemporary workLocal areaFlexible hours$203k - $338.4k
...Regeneron Pharmaceuticals, Inc is seeking a Senior Director, GMP Counsel Regulatory to provide legal advice for global manufacturing operations. This role requires significant expertise in GMP compliance and regulation, with at least 15 years of experience in a pharmaceutical...Regulatory- ...a Logistics & Trade Compliance Specialist in Slingerlands, New York, to ensure smooth industrial shipments and full regulatory compliance in the global supply chain. Ideal candidates bring 5–7 years of logistics experience, focusing on heavy haul and project cargo. This...Regulatory
$249.97k - $388.13k
...visionary Senior Director, Global Clinical Development (GCD),... ...global clinical development strategy across multiple programs. The... ...global clinical trials and regulatory filing activities. The Senior... ...stage trials and regulatory submissions. • Provide medical and...RegulatoryTemporary workLocal areaFlexible hours$249.97k - $388.13k
...Senior Director, Global Medical Safety physician (psychedelics... ...clinical, operational, ethical and regulatory considerations associated... ...establish a robust safety strategy that supports accelerated... ...as well as global regulatory submissions, including INDs, NDAs, MAAs...RegulatoryTemporary workLocal areaFlexible hours- Cognizant is seeking a Veeva Vault RIM Test & Validation Lead to drive validation strategy and ensure compliance with regulatory systems for global submissions. This hybrid role will require collaboration with regulatory affairs, quality, and IT stakeholders. The ideal...Regulatory
$120k - $125k
...Overview Scope of Responsibilities: The Formulary Strategy Manager, Trade (RPh) will lead the development and execution of trade-related... ...appropriateness, and maintain compliance with contractual and regulatory requirements. The position requires strong clinical knowledge,...RegulatoryMinimum wageContract workLocal area- ...Incredible opportunity to shape global regulatory strategy and deliver breakthrough science while working from home! We’re looking for a seasoned... ...strengthen team effectiveness, process efficiency, and submission readiness. • Prepare and deliver strategic dashboards,...RegulatoryWork at officeRemote workWork from homeWorldwide
$88.3k - $143.9k
...engineering product management, regulatory compliance (design controls... ..., and other development/strategy collaborators. Define... ...Chemistry Manufacturing Controls (CMC) and Global development timing and... ...development (e.g., IND/IMPD, BLA Submission, Clinical Pharmacy Manuals)...RegulatoryLocal area- ...more than 65% of application development activity." Mendix, the global leader in enterprise low-code, is fundamentally reinventing the... .... This role will serve as the owner of PR and social media strategy and execution at Mendix. You will drive global strategy development...Local area
$120k - $127k
...Title Director, Investment Strategy EOE Statement As an Equal Opportunity / Affirmative Action Employer, It is the... .... Maintains cutting edge body of knowledge in the areas of regulatory, industry trends, and investments. Research and evaluate industry...RegulatoryApprenticeshipWork at officeRemote work$124k - $280k
...time Travel Requirements: Up to 60% At PwC, our people in strategy consulting focus on providing strategic guidance and insights... ...trends (DeFi, tokenized assets, stablecoins, DAOs) and their regulatory, risk, and compliance implications Experience building business...RegulatoryFull timeContract workH1b- ...Technology And Solutions Strategist Our team members are at the heart of everything we... ...Cencora, offering animal health services globally. The Technology And Solutions... ...capabilities Develop and Execute sales strategies with high level of ability Experience...Temporary workLocal area
$82.5k - $209.5k
...drive Oracle Health’s healthcare payer strategy in the United States. In this role,... ...healthcare interoperability standards and regulatory programs, including FHIR and CMS... ...Serve as a trusted advisor and product strategist for executive stakeholders at health plans...RegulatoryContract workTemporary workFlexible hours$145k - $165k
...New York City. Fujifilm is globally headquartered in Tokyo with... ...with review of quotes, submissions, and other documentation in... ...in Legal, IT, HR, Finance, Regulatory and other core functions in... ...and recommend and implement strategies to resolve compliance problems...RegulatoryRemote workFlexible hours$109.2k - $223.4k
...Job Description The Director for Global Defense - Japan is responsible for leading... ...priorities while operating within Japan’s regulatory, security, and procurement environment.... ...ecosystem partners; shapes long-range capture strategy; and ensures secure delivery of mission...RegulatoryContract workTemporary workFor contractorsLocal areaFlexible hours- ...Acxiom is looking for an Industry Strategist to join our Product Consulting Group. You will... ...,agency offerings,direct marketing strategies, and industry dynamics. Stay abreast... ...create an account to monitor your resume submissions. Click on the Sign In link above to create...InternshipLocal areaRemote work
$126.6k - $207.3k
...research platforms Knowledge of industry regulatory frameworks, data governance, and... ...owning large strategic accounts, or managing global business responsibilities and are... ...excited to help define OCI's long-term growth strategy within the Health & Science industry. Should...RegulatoryContract workTemporary workWorldwideFlexible hours- Experienced Quantitative Strategists If you have an existing strategy, we offer an excellent environment for you to fully realize its potential across global markets by leveraging our platform. Equities Track record of at least 2 years running quantitative equities...
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