Senior CMC Regulatory Lead - Remote
ValueBase Consulting
ValueBase Consulting is looking for a CMC Regulatory Affairs Consultant to manage CMC submissions for clinical trials remotely. Candidates should have a Bachelor’s Degree or higher, with 10+ years in life sciences and 5+ years in regulatory affairs. The role involves developing CMC content, providing regulatory guidance, and managing cross-functional projects. Experience with global original IND, NDA, BLA, MAA filings is required. Candidates must be located in the USA. #J-18808-Ljbffr
$212k - $333.19k
...life-changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors,... ...classified as hybrid following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda Compensation...Remote workSeniorRegulatoryMinimum wageTemporary workLocal areaWorldwideNight shift- ...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...SeniorRegulatory
- ...Corcept Therapeutics in Redwood City, California is seeking a Director of Regulatory Affairs CMC to lead the preparation of CMC regulatory documents from pre‑IND to marketing authorization across multiple therapeutic areas. This hybrid role requires oversight of a high...SeniorRegulatory
- ...Immatics-US in Houston is searching for a Senior Program Manager, CMC to drive cross-functional Chemistry, Manufacturing, and Controls activities... ...collaboration across manufacturing, quality, and regulatory teams to support clinical development. Candidates should...SeniorRegulatory
- ...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...SeniorRegulatoryRelocation package
$137k - $215.27k
...Initial Therapeutics, Inc. is looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device experience and a BS/BA degree in a scientific discipline. Responsibilities include executing...SeniorRegulatory- ...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...Remote workRegulatory
- ...Initial Therapeutics, Inc. seeks an experienced regulatory CMC leader in Indianapolis, IN. This position involves providing strategic oversight... ...7,400, with relocation assistance and a comprehensive benefits package offered. Remote options may be available. #J-18808-Ljbffr...Remote workRegulatoryRelocation package
$221k - $286k
...Kite Pharma is seeking a Senior Director of Regulatory CMC in Oceanside, CA, to provide global leadership for the regulatory activities of CAR T cell... ...$221,000 to $286,000 with additional benefits. This position offers flexible work with remote options. #J-18808-Ljbffr...Remote workRegulatoryFlexible hours- ...Kite Pharma, based in California, is looking for a Regulatory CMC Lead to manage submissions for global CAR-T programs. The role involves leading... ...in Regulatory CMC. Kite offers a hybrid working model, allowing for flexibility with remote and onsite work. #J-18808-Ljbffr...Remote workRegulatory
$169.5k - $248.6k
...the world. Purpose: The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative... ...Team (inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists)...Remote workSeniorRegulatoryFull timeLocal areaFlexible hours$70 - $117 per hour
...Planet Pharma is seeking a Director of Regulatory Affairs to provide senior regulatory leadership in a fast-paced biotech environment. This role involves leading global regulatory strategies for Phase III clinical programs, particularly in vaccine development, and serving...Remote workSeniorRegulatory$146k - $215k
...Compliance for Global Repair Stations to lead quality aspects of maintenance and ensure... ...Key responsibilities include overseeing regulatory compliance, providing expert guidance, and... ...and a proven leadership background. This remote role offers a competitive salary range of...Remote workSeniorRegulatory- A biopharmaceutical company is seeking a Senior Manager, Global Regulatory Affairs Labeling to lead its global labeling initiatives. This role involves strategy... ...global regulations. The position offers a competitive salary and the flexibility of remote work. #J-18808-LjbffrRemote workSeniorRegulatory
$130.8k - $209.4k
...alignment with program goals, regulatory expectations, and business needs... ...and expiry‑related planning. Lead or support investigations for... ...presence at the Moderna site. Remote work is not eligible. Preferred... ...working in cross‑functional CMC teams within a matrixed development...Remote workRegulatoryPermanent employmentFull time$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...Remote workSeniorRegulatory- ...is seeking a Sr. Energy Storage NERC Compliance Manager, fully remote in the USA. This critical role involves developing and implementing... ...experience in grid infrastructure and a strong grasp of regulatory standards. The position offers an attractive compensation package...Remote workSeniorRegulatoryFlexible hours
- ...dynamischen Teams, das digitale Innovationen vorantreibt. Zu den Aufgaben gehören die Identifikation neuer Projektmöglichkeiten und der Aufbau starker Kundenbeziehungen. Diese Position bietet flexible Arbeitszeiten und die Möglichkeit, remote zu arbeiten. #J-18808-LjbffrRemote workSeniorRegulatoryFlexible hours
- ...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... .... This position offers remote work flexibility and competitive time...Remote workSeniorRegulatory
- ...A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities....Remote workSeniorRegulatory
$110 - $116 per hour
...Sunrise Systems, Inc. is seeking a Regulatory Affairs Specialist-Sr in Cordova, TN, with an option for remote work. This role involves preparing and reviewing regulatory submissions, leading project teams, and developing global regulatory strategies for new medical devices...Remote workSeniorRegulatoryHourly pay- ...Technologies, Inc. is seeking a Licensing Manager to serve as a senior‑level expert in advanced reactor licensing. This position... ...collaborating with stakeholders, and ensuring compliance with regulatory frameworks. The ideal candidate should have a Bachelor's degree...Remote workSeniorRegulatory
$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...Remote workSeniorRegulatory- ...United Cerebral Palsy of Georgia is seeking a Regulatory Affairs Professional to lead regulatory strategies for medical devices in a fully remote position. The role requires over 8 years of experience in FDA submissions and regulatory compliance with a BA or BS degree....Remote workSeniorRegulatory
$82.92k - $150k
...A leading cryptocurrency exchange is seeking a Senior Compliance Officer to develop and implement compliance programs related... ...$82,921 to $150,000 and is fully remote, providing flexibility in a dynamic environment focused on regulatory compliance and risk mitigation. #J-...Remote workSeniorRegulatory- ...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...Remote workSeniorRegulatory
- ...In this role the selected candidate will lead a team of MS&T professionals by providing... ...strategic and operational leadership for the CMC execution and lifecycle management... ...Manufacturing Operations, Quality Assurance, Regulatory and the Program Team. You will ensuring...SeniorRegulatoryWork at office2 days per week3 days per week
- ...A leading staffing and recruiting firm in Boston is seeking a seasoned cybersecurity compliance professional... ...have significant experience in military regulatory frameworks and auditing complex systems. The company offers remote work and flexible schedules, fostering a...Remote workSeniorRegulatoryFlexible hours
- ...Solventum seeks a Principal Regulatory Affairs Specialist to lead regulatory strategy and submissions for its Dental Solutions business. This remote role requires extensive experience in regulatory affairs within the drug and medical device industry, supporting global...Remote workSeniorRegulatory
- ...is looking for a Chief Compliance Officer to lead compliance efforts for its Chicago-based CFTC-regulated business. This senior role involves designing and implementing... ...compliance, DCM and DCO operations, and a strong regulatory background. This position offers an...Remote workSeniorRegulatory
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