Senior CMC Regulatory Lead — Global Submissions
Scorpion Therapeutics
Scorpion Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global CMC regulatory strategies for small molecule drug development and commercialization, with emphasis on oral solid dosage forms. You will own submissions, liaise with global health authorities, and guide cross-functional teams through lifecycle management. The role requires 8+ years in regulatory affairs, strong CMC expertise, and the ability to drive regulatory plans across INDs, NDAs, and #J-18808-Ljbffr Scorpion Therapeutics
- ...Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs - CMC to lead global CMC strategy for small molecule development and registration... ...and Regulatory Affairs to ensure timely, high-quality submissions and lifecycle changes. Experience in IND/CTA, NDA/MAA...Regulatory
- Piper Companies seeks a Senior Director, Quality & CMC Regulatory Strategy to provide strategic CMC and quality regulatory guidance across biotech and... ..., from development to lifecycle management. The role leads global regulatory strategies, advises on pathways and health...SeniorRegulatory
- Scorpion Therapeutics is seeking an Associate Director, Regulatory Affairs - CMC to drive global regulatory strategy for small molecule drug programs. You will oversee CMC documentation, lifecycle management, and post-approval changes while coordinating with Regulatory...RegulatoryRemote job
- The Goldman Sachs Group, Inc. is seeking a Global Banking & Markets-Public Compliance officer to prevent, detect and mitigate regulatory and reputational risk. The role covers sales and trading, working with Legal, Risk, Ops, Tech and Internal Audit to uphold conduct standards...SeniorRegulatory
- Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to provide strategic CMC and quality regulatory... ...and lifecycle management. The role leads global regulatory strategies, advises on pathways and submissions, and oversees INDs, global filings, and...SeniorRegulatoryRemote job
- Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to guide regulatory strategy... ...pharmaceutical clients. The role focuses on leading global CMC activities, client liaison,... ...to ensure compliant submissions and strategic impact. The ideal candidate...SeniorRegulatoryRemote job
- ...in New Jersey is seeking an Associate Director, Regulatory Affairs - CMC. This role involves leading global regulatory strategy for product development and collaboration... ...skills, and the ability to prepare regulatory submissions including INDs and NDAs. #J-18808-Ljbffr PTC...Regulatory
- Amgen is seeking a Local Regulatory Representative (Manager) in the United States to lead regulatory strategies for Amgen products, ensuring compliance... ...teams to align local requirements with global plans and prepare regulatory submissions. Responsibilities include planning...SeniorRegulatoryLocal areaFlexible hours
- ...the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules... ...robust regulatory strategies, compliance, and submission excellence. Main Responsibilities Leading the global CMC Regulatory strategy for one small molecule...SeniorRegulatoryLocal area
- Travere Therapeutics seeks an Associate Director, Regulatory Project Manager to lead global regulatory activities and ensure submissions align with development plans. Remote in San... ...Regulatory Affairs, Clinical Development, CMC, Quality and Commercial to ensure compliance...RegulatoryRemote job
- ...Summary The Manager/Senior Manager, CMC Quality Control (QC)... ...role serves as a QC lead for external contract... ...Technical Operations, Regulatory Affairs, Quality... ...and review regulatory submissions, responses to health... ...INDs, BLAs, and other global filings Prepare and...SeniorRegulatoryContract workWork at officeWork from home2 days per week
- ...Attorney / Counsel - Junior / Senior / Lead New York, New York,... ...specialized vertical in Legal, Regulatory Compliance, and Corporate Governance... ...financial institutions, and global corporations and... ...impactful cases, regulatory submissions, process improvements, policy...SeniorRegulatoryContract work
- ...Senior Director, Biologics CMC (4 days onsite, 1 day remote) Position Summary... ...analytical development, quality, regulatory CMC, and external... ...with hands-on activities, leading technical discussions,... ...Demonstrated experience managing global CDMOs. Strong knowledge...SeniorRegulatoryFull timeRemote work
- Scorpion Therapeutics is seeking a Senior Associate, Regulatory CMC to lead strategy, compliance, and submissions for biologics and cell therapy products. You will prepare IND/IMPD submissions, manage regulatory systems, and support FDA inspections while ensuring 21 CFR...SeniorRegulatoryRemote job
$65 - $70 per hour
...Job Title: Senior Internal Communications Lead Location: New York New York 10004... ...and Resilience (CDRR), a global Technology division operating... ...activities, coordinating submissions and related content with... ...organizational, regulatory, cyber, risk, or leadership...SeniorRegulatoryFull timeContract workTemporary workWork at officeWorldwideShift work- REGENXBIO Inc. is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategy for a therapeutic area from early development... ...partner across functions to keep programs moving, drive submissions, and develop high-quality dossiers while collaborating...Regulatory
- BeOne Medicines Ltd. seeks a Regulatory Affairs Lead to drive global regulatory strategies for oncology development programs, ensuring timely market... ...regions. You will lead and mentor teams, oversee regulatory submissions, and coordinate with authorities to align with the...Regulatory
- Role Senior Manager, Global Regulatory Affairs for Marketed Products, supporting regulatory submission processes and compliance for Takeda's global portfolio. Responsibilities collaborate with regional leads and cross-functional teams to prepare and submit regulatory dossiers...SeniorRegulatoryRemote work
- Scorpion Therapeutics is seeking a Senior Regulatory Affairs leader to oversee global filings and compliance for a late-stage ophthalmic biologic... ...and European marketing authorization. You will lead end-to-end submissions (BLA, MAA, INDs, CTAs) and post-approval activities...RegulatoryRemote job
- TG Therapeutics, Inc. is seeking an experienced Regulatory CMC consultant with BLA writing expertise to provide hands-on authoring and submission support for biologics. The role focuses on Module 3 and related Quality content, collaborating with cross-functional teams to...SeniorRegulatoryRemote job
- ...Senior/Principal Scientist, In Vitro Biology Team Lead Location: New York, New York / Onsite Reporting to: Senior Director, Head of Radiopharmacology... ...qualify assays to support IND-enabling studies, regulatory submissions, and clinical translational research. Serve...SeniorRegulatoryFull timeContract workLocal area
$211.28k - $316.92k
...Category: Legal, ProfessionalCompany: CitiThe Senior Lead Counsel I is a senior level position... ...business practices, laws, rules, and regulatory guidelines, escalating as appropriateCollaborates... ...with the Legal team on a regional and global basisParticipates in Business planning...SeniorRegulatoryFull time- uniQure is seeking a Vice President, Global Regulatory Therapeutic Lead to provide strategic and operational leadership for regulatory activities... ...involves overseeing Health Authority engagements, managing submissions, and guiding risk assessment while mentoring regulatory...RegulatoryRemote job
- ...implemented in compliance with applicable regulatory requirements. The team provides end-to-... ...regulatory risk. Role Overview The Lead Product Compliance Consultant is responsible... ...filings through SERFF, including coordinating submissions, conducting due diligence reviews,...SeniorRegulatoryWork at officeLocal area3 days per week
$211.28k - $316.92k
...Category: Legal, ProfessionalCompany: CitiThe Senior Lead Counsel is a position responsible for... ...and trade receivables, preferably with global exposure. Must be collaborative.This... ...accepted business practices, laws, rules, and regulatory guidelines, escalating where...SeniorRegulatoryFull time$170k - $190k
Senior Manager, Global Regulatory Affairs Labeling This range is provided by Planet Pharma. Your actual pay... ...Labeling plays a key role in leading end-to-end labeling activities for commercial... ...) prior to internal approval and/or submission of labeling to health authorities....SeniorRegulatoryFull timeWork experience placementLocal areaRemote work$211.28k - $316.92k
...investment objective, and translating the CIO's global investment views into sophisticated,... ...Citi Wealth and Citi as a whole.The Senior Portfolio Specialist will have the opportunity... ...methods.Consistently follow and support regulatory policies.Experience and Qualifications...SeniorRegulatoryFull timeWork at office- Precision Medicine Group is expanding its regulatory capabilities across Latin America and is hiring its first Senior Regulatory and Start Up Specialist (Senior RSS)... ...site activation readiness, prepare CTAs and submission dossiers for CA/EC, and collaborate with CROs...SeniorRegulatoryLocal area
$110k - $160.91k
...advancing your career with a global leader in environmental consulting... .... This role is focused on leading and overseeing routing and... ...stakeholder engagement, and regulatory documentation and state siting... ...Electric Transmission Line Siting Senior Lead, you will serve as a...SeniorRegulatoryFull timeFixed term contractCasual workWork at officeRemote workFlexible hoursShift work- Fernridge Group is seeking an Associate Director to lead its Compliance team in New York. This role owns major risk areas, drives... ...independently in a fast-paced environment, with a track record in private funds and regulatory submissions. #J-18808-Ljbffr Fernridge GroupSeniorRegulatory
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