Senior CMC Regulatory Lead - Biologics
BeiGene
BeiGene, Ltd. is seeking an AD, Regulatory Affairs CMC dedicated to developing and implementing global regulatory strategies for market access. You will manage CMC aspects through all development phases and coordinate with key stakeholders. The ideal candidate will have over 8 years of experience in regulatory affairs, with strong knowledge of GMP regulations, and excellent communication and project management skills. This role requires a proactive mindset and the ability to navigate complex regulatory landscapes. #J-18808-Ljbffr
$274.8k - $354.8k
...BeiGene, Ltd. is seeking an Executive Director of Regulatory Affairs, CMC, to lead the U.S. Biologics Regulatory team. This pivotal role includes strategic leadership of regulatory activities for biologics, ensuring compliance and high-quality submissions across the product...RegulatoryRemote work$122.25k - $176.58k
## Global Regulatory Affairs (GRA) Chemistry, Manufacturing and Controls (CMC) CMC LeadBewerbenlocations: Morristown, NJ: Framingham... ...and Controls (CMC) CMC Lead**Location:** Morristown, NJ / Framingham... ...discipline (Chemistry, Biology, Pharmacy, or related field).*...RegulatoryTemporary workWorldwideFlexible hours$183.96k - $204.84k
...Senior Principal Scientist | Antibody-siRNA Bioanalytical & Biodistribution Strategy Lead page is loaded## Senior Principal Scientist | Antibody... ...of experts in chemistry, biology, toxicology, clinical... ...selection and successfully file regulatory applications.* Lead...SeniorRegulatoryFlexible hours- ...Barrington James is seeking a Regulatory Affairs CMC Specialist/Manager to lead client regulatory CMC projects. This fully remote role requires 7+ years of regulatory affairs experience, strong CMC expertise, and proficiency in managing submissions for INDs and NDAs. The...RegulatoryRemote work
- ...ensuring compliance and operational success. The role involves leading CMOs, preparing regulatory documents, and collaborating across teams to optimize... ...has a relevant advanced degree and experience in Biologics Drug Product GMP manufacturing. Strong communication skills...Regulatory
$97.5k - $126.5k
...NJ office. Ramboll is hiring for a Senior Lead Consultant to join the Mergers &... ...support to clients across a variety of regulatory program areas including hazardous waste... ...science, geology, chemistry, physics, or biology). Advanced degree desirable, but not required...SeniorRegulatoryFull timeWork at officeLocal areaFlexible hours$2,000 - $4,500 per month
...A growing med-spa organization is seeking a Senior Legal Compliance and Licensing Specialist to lead compliance across multiple U.S. locations. This role demands... ...a professional with over 5 years of experience in regulatory compliance within the med-spa or healthcare sector...SeniorRegulatoryRemote work- A biopharmaceutical company is seeking a Senior Manager, Global Regulatory Affairs Labeling to lead its global labeling initiatives. This role involves strategy development for labeling, ensuring compliance, and managing cross-functional stakeholder reviews. Candidates...SeniorRegulatoryRemote work
- ...A leading financial services firm is seeking a Senior Compliance Manager to oversee compliance initiatives and manage regulatory reporting requirements. The ideal candidate has 7-10+ years of experience in compliance within the financial services industry, particularly...SeniorRegulatoryRemote work
- ...Framework Ventures is seeking an experienced Compliance Manager to oversee AML and regulatory compliance in Hong Kong/Singapore. This role involves shaping compliance infrastructure, managing regulatory relationships, and ensuring adherence to compliance programs across...SeniorRegulatory
- MSD Malaysia is seeking a Director, Quality Lead based in Pennsylvania to oversee quality activities for large molecule drug development... ...candidate will have strong leadership skills, a background in Biologics, and an ability to work with cross-functional teams. This is an...Senior
- ...storage assets. Ideal candidates should have 6-10+ years of NERC compliance experience in grid infrastructure and a strong grasp of regulatory standards. The position offers an attractive compensation package, including flexible work hours, health benefits, and...SeniorRegulatoryRemote workFlexible hours
- ...Client is seeking an experienced CMC Project Manager to provide... ...engagement is aligned to regulatory filing milestones, including... ...This role will report into the Senior Director of CMC Project Management... ...supporting late‑stage biologics programs Strong background in...RegulatoryContract workImmediate startRemote work
$186.49k - $278.88k
...Otsuka Pharmaceutical Co., Ltd is seeking a skilled individual to lead labeling strategy and development for their products in the... ...experience in pharmaceutical labeling, a strong understanding of regulatory affairs, and excellent communication skills. A competitive...SeniorRegulatory$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...SeniorRegulatoryRemote work$82.92k - $150k
...A leading cryptocurrency exchange is seeking a Senior Compliance Officer to develop and implement compliance programs related to BSA/AML and KYC regulations... ...flexibility in a dynamic environment focused on regulatory compliance and risk mitigation. #J-18808-Ljbffr...SeniorRegulatoryRemote work- ...Ventra-Health is seeking a Senior Regulatory Affairs Specialist in the United States. The role involves managing the Merit-Based Incentive Payment System (MIPS) for Hospital Medicine and Emergency Medicine clients, ensuring compliance, and collaborating closely with key...SeniorRegulatory
$122.5k - $175k
...Ideal applicants will have a strong background in AI/ML architecture and GRC engineering, with a commitment to driving efficiency in regulatory processes. This full-time position offers a competitive salary range of $122,500 - $175,000 and numerous benefits including...SeniorRegulatoryFull time- ...Framework Ventures is seeking a Compliance Officer to manage regulatory requirements for Figure Markets in the US and international jurisdictions. Candidates should have deep knowledge of cryptocurrency regulations, 3+ years of experience with exchange platforms, and...SeniorRegulatoryRemote work
- ...A leading data-focused CRO is looking for a skilled professional to manage GCP compliance and quality oversight. Applicants should... ...solving skills are essential. This role involves maintaining high regulatory standards and may require travel both domestically and...SeniorRegulatory
- ...A leading biotechnology firm is seeking an Associate Director of Biostatistics for a remote position. This role focuses on providing statistical leadership for a major regulatory filing and collaborating with cross-functional teams. The ideal candidate should have a PhD...SeniorRegulatoryRemote work
- ...A recruitment agency is seeking a Lead Programmer to provide technical support, lead statistical programming projects using SAS and... ...monitoring, oversight of complex trials, and ensuring compliance with regulatory requirements. The ideal candidate will have experience with...SeniorRegulatory
- ...A leading cancer research institution is seeking a Senior Trial Master File Manager to oversee management and maintenance of TMF. This role ensures quality and compliance with regulatory standards and involves team leadership, document management, and audits. The ideal...SeniorRegulatoryContract workRemote work
- ...A leading biotechnology company is seeking a Regulatory Writing Senior Manager to lead writing activities for product submissions. This role involves authoring and overseeing regulatory documents, providing expertise, and mentoring junior writers. The ideal candidate...SeniorRegulatoryRemote workFlexible hours
$130k - $133k
...experience and involves nationwide travel. Responsibilities include site monitoring, project management, and ensuring compliance with regulatory guidelines. Candidates must have a life science degree or equivalent experience. The position offers a competitive pay range of $...SeniorRegulatory$93.6k - $123.6k
...BeiGene, Ltd. is looking for a Senior Associate in Regulatory Promotional Operations in the United States. The role involves assisting with the planning and coordination of promotional materials while supporting regulatory submissions. Ideal candidates should have a BA...SeniorRegulatory- ...conducting risk assessments, and supporting AML/CTF controls. The ideal candidate will have over 5 years of experience in compliance and regulatory roles, demonstrate strong analytical abilities, and possess excellent communication skills. A comprehensive benefits package,...SeniorRegulatory
- ...Ohio State University is seeking a Senior Regulatory Compliance Officer for its Clinical Trials Office. This pivotal role ensures that investigator-initiated trials meet university, state, and federal regulations. Responsibilities include regulatory document review, provide...SeniorRegulatoryWork at officeRemote workFlexible hours
$173.7k - $202.65k
...Cytokinetics, Inc. is seeking a Senior Manager, Regulatory Writing to oversee the development of regulatory documents essential for product submissions... ...skills and should be adept in project management and leading documentation efforts across teams. A competitive salary...SeniorRegulatoryRemote work- ...A leading nuclear technology firm is seeking a Senior Manager, Business Development to advance late-stage commercial opportunities and facilitate contract executions. The successful candidate will be responsible for coordinating state engagement, managing complex agreements...SeniorRegulatoryContract work
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