Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior CMC Regulatory Lead — Global Submissions in New York, NY vacancy
  •  ...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

    PTC Therapeutics, Inc.

    New York, NY
    2 days ago
  • 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... 
    Senior
    Regulatory

    ZP Group

    New York, NY
    4 days ago
  • 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... 
    Regulatory
    Remote job

    Scorpion Therapeutics

    New York, NY
    3 days ago
  • 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... 
    Senior
    Regulatory

    The Goldman Sachs Group

    New York, NY
    11 hours ago
  • 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... 
    Senior
    Regulatory
    Remote job

    Piper Companies

    New York, NY
    3 days ago
  • 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... 
    Senior
    Regulatory
    Remote job

    Piper Companies

    New York, NY
    4 days ago
  •  ...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

    PTC Therapeutics, Inc

    New York, NY
    11 hours ago
  • 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... 
    Senior
    Regulatory
    Local area
    Flexible hours

    Regulatory Jobs

    New York, NY
    1 day ago
  •  ...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... 
    Senior
    Regulatory
    Local area

    Excelya

    New York, NY
    1 day ago
  • 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... 
    Regulatory
    Remote job

    Scorpion Therapeutics

    New York, NY
    3 days ago
  •  ...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... 
    Senior
    Regulatory
    Contract work
    Work at office
    Work from home
    2 days per week

    Lexeo Therapeutics

    New York, NY
    14 days ago
  •  ...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... 
    Senior
    Regulatory
    Contract work

    Catalyst Labs, LLC

    New York, NY
    4 days ago
  •  ...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... 
    Senior
    Regulatory
    Full time
    Remote work

    GTS Scientific

    New York, NY
    3 days ago
  • 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... 
    Senior
    Regulatory
    Remote job

    Scorpion Therapeutics

    New York, NY
    3 days ago
  • $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... 
    Senior
    Regulatory
    Full time
    Contract work
    Temporary work
    Work at office
    Worldwide
    Shift work

    Pinnacle Group

    New York, NY
    5 days ago
  • 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

    REGENXBIO Inc.

    New York, NY
    1 day ago
  • 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

    BeiGene, Ltd.

    New York, NY
    2 days ago
  • 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... 
    Senior
    Regulatory
    Remote work

    Scorpion Therapeutics

    New York, NY
    3 days ago
  • 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... 
    Regulatory
    Remote job

    Scorpion Therapeutics

    New York, NY
    3 days ago
  • 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... 
    Senior
    Regulatory
    Remote job

    TG Therapeutics, Inc.

    New York, NY
    11 hours ago
  •  ...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... 
    Senior
    Regulatory
    Full time
    Contract work
    Local area

    Actinium Pharmaceuticals, Inc.

    New York, NY
    2 days ago
  • $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... 
    Senior
    Regulatory
    Full time

    Citigroup

    New York, NY
    20 hours ago
  • 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... 
    Regulatory
    Remote job

    Scorpion Therapeutics

    New York, NY
    3 days ago
  •  ...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,... 
    Senior
    Regulatory
    Work at office
    Local area
    3 days per week

    New York Life Insurance Company

    New York, NY
    4 days ago
  • $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... 
    Senior
    Regulatory
    Full time

    Citigroup

    New York, NY
    2 days ago
  • $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.... 
    Senior
    Regulatory
    Full time
    Work experience placement
    Local area
    Remote work

    Planet Pharma

    New York, NY
    20 hours ago
  • $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... 
    Senior
    Regulatory
    Full time
    Work at office

    Citigroup

    New York, NY
    2 days ago
  • 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... 
    Senior
    Regulatory
    Local area

    Pfm

    New York, NY
    1 day ago
  • $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... 
    Senior
    Regulatory
    Full time
    Fixed term contract
    Casual work
    Work at office
    Remote work
    Flexible hours
    Shift work

    ERM Group

    New York, NY
    20 hours ago
  • 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 Group
    Senior
    Regulatory

    Fernridge Group

    New York, NY
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior CMC Regulatory Lead — Global Submissions. Be the first to apply!