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

Global Regulatory Affairs Lead - IND/CTA Submissions

Kailera Therapeutics

Kailera Therapeutics seeks an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early and late-phase investigational products, guiding IND/CTA submissions and future marketing applications, and advising cross-functional teams on regulatory filings. The role collaborates with Regulatory CMC and Regulatory Operations to ensure scientific data and submissions meet agency expectations in a compliant manner. Onsite in Waltham, MA, 3–4 days a week. #J-18808-Ljbffr Kailera Therapeutics

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Lead - IND/CTA Submissions in Boston, MA vacancy
  •  ...Medicines in Boston is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs. This role...  ...Affairs & Quality and will manage global regulatory submissions (IND/CTA/NDA/MAA) and interactions with health authorities worldwide... 
    Suggested
    Worldwide

    Beeline Medicines

    Boston, MA
    4 days ago
  •  ...Boston, MA seeks an experienced Regulatory CMC professional to drive...  ...deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical Operations, and...  ...and ensure timely, compliant submissions across development, commercialization... 
    Suggested

    Rhythm Pharmaceuticals Inc.

    Boston, MA
    3 days ago
  • $211.5k - $258.5k

    Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for...  ...relationship lead for pre-IND through Phase II clinical...  ...member of the Regulatory Affairs team, this individual also...  ...pre-IND planning, IND/CTA submission strategy, Phase I/II/III... 
    Suggested
    Local area
    Flexible hours
    2 days per week

    Beeline Medicines

    Boston, MA
    1 day ago
  •  ..., Inc. is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio...  ...regulatory-CMC strategies, coordinate INDs/BLAs, prepare compilations, review dossiers for submission readiness, and guide cross-functional teams... 
    Suggested

    Anagram Therapeutics, Inc.

    Natick, MA
    23 hours ago
  •  ...seeking an Associate Director, Global Regulatory Affairs Compliance, to advance regulatory strategies across its lead and follow‑on programs. Based in...  ...to ensure compliant submissions and timely milestones. You will manage INDs, NDAs, and health authority materials... 
    Suggested

    Olema Oncology

    Cambridge, MA
    3 days ago
  •  ...Francisco, CA is seeking an Associate Director, Global Regulatory Affairs, Compliance to lead regulatory strategies, ensure compliance...  ...advance palazestrant and OP-3136 through INDs and NDAs. You will craft high-quality submissions, maintain knowledge of 21 CFR parts and... 
    2 days per week

    Olema Oncology

    Boston, MA
    3 days ago
  • Scorpion Therapeutics seeks a Global Regulatory Lead to own global regulatory strategies from entry to lifecycle, providing strategic and...  ...voice with the US FDA. The role includes overseeing US FDA submissions (INDs/NDAs/BLAs), shaping development plans, and aligning... 
    Local area
    Relocation package

    Scorpion Therapeutics

    Boston, MA
    4 days ago
  •  ...United States is seeking an Executive Director, Regulatory Affairs to serve as Global Regulatory Lead for assigned programs and report to the Senior VP...  ...will drive global regulatory strategy, oversee submissions (IND/CTA/NDA/MAA) and ensure compliance across regions while... 
    For contractors

    BioSpace

    Boston, MA
    2 days ago
  • $177k - $278.08k

     ...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the...  ...regulatory strategy and lead major submissions for high-impact oncology programs.How...  ...understanding broad concepts within regulatory affairs and implications across the... 
    Minimum wage
    Temporary work
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    1 day ago
  • Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule. You will manage a portfolio of submissions,... 

    Vertex Pharmaceuticals

    Boston, MA
    4 days ago
  •  ...Oncology is seeking an experienced Associate Director, Regulatory Affairs to join our Regulatory Affairs team and shape global regulatory strategy for our clinical pipeline. This hands-on leader will drive submission planning and interactions with health authorities,... 

    alpha9oncology

    Boston, MA
    4 days ago
  • A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA... 

    Barrington James

    Boston, MA
    1 day ago
  • WHOOP is seeking a Regulatory Affairs Specialist II, Expansion to support global market access for SaMD and wearable health technologies. You will lead international submissions, maintain EU MDR documentation, and coordinate with Notified Bodies and regulators while ensuring... 
    Work at office
    Worldwide
    Relocation

    Whoop

    Boston, MA
    2 days ago
  • Verto People is seeking a Regulatory Affairs Executive to own the global regulatory function for a precision oncology portfolio....  ...Team, shaping regulatory strategy from Pre-IND through BLA/NDA submissions. The candidate will lead interactions with major health... 

    Verto People

    Boston, MA
    23 hours ago
  •  ...in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development...  ...publishing, cross-functional coordination with regulatory affairs, and strategic execution to ensure timely, compliant... 

    Merida Biosciences

    Cambridge, MA
    4 days ago
  • 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. Candidates... 
    Remote job

    Barrington James

    Boston, MA
    2 days ago
  • $170k - $220k

     ...medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication skills,... 

    Solid Biosciences

    Boston, MA
    1 day ago
  • Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory...  ...in preparing and managing regulatory submissions with minimal guidance Skilled in analyzing...  ...skills and knowledge in regulatory affairs Strong strategic planner with a... 
    Full time
    Local area

    Takeda

    Cambridge, MA
    1 day ago
  • $142.5k - $256.5k

    The RoleThe Associate Director, Global Regulatory, CMC will be responsible for coordinating...  ...regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risksProvide...  ...2010, we have aspired to build the leading mRNA technology platform, the... 
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    2 days ago
  • Moderna is seeking a Global Regulatory CMC Lead to coordinate CMC activities across product lifecycles and develop global regulatory strategies...  ..., strong collaboration skills, and the ability to drive submissions through health authorities while maintaining alignment... 

    BioSpace

    Norwood, MA
    1 day ago
  • $150k - $200k

    Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge...  ...development and global regulatory submissions, ensuring quality and...  ...consultations & submissions (e.g. INDs, FDA/EMA/PMDA briefing...  ...Data Management, Regulatory Affairs, Safety, and all stakeholders... 
    Worldwide

    Orion Corporation

    Cambridge, MA
    3 days ago
  • A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in...  ...strong background in regulatory affairs. You will lead multiple teams and oversee all FDA submissions, driving strategic... 

    Takeda

    Cambridge, MA
    1 day ago
  • $150k - $200k

    A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development...  ...over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge,... 

    Orion Corporation

    Cambridge, MA
    3 days ago
  • Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US. Applicants should have... 

    Alnylam Pharmaceuticals

    Cambridge, MA
    4 days ago
  • A global pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and managing all assigned programs while ensuring compliance with advertising and promotion regulations. Candidates should... 
    Remote work

    BioSpace

    Cambridge, MA
    2 days ago
  • Foundation Medicine in Boston seeks a Senior Specialist, Regulatory Affairs (CDx) to lead regulatory submissions, shape strategy, and guide cross-functional teams through FDA pathways for companion diagnostics. You will prepare packages, respond to agency inquiries, review... 

    Foundation Medicine

    Boston, MA
    9 hours ago
  • About The Role As the Global Regulatory Lead (GRL), you will be the accountable decision maker...  ...issues management) Oversee US FDA submissions and interactions (INDs, NDAs, BLAs) Drive high-quality...  ...PharmD/PhD) and 8+ years in regulatory affairs and/or drug development OR... 
    Local area
    Relocation
    Flexible hours

    Scorpion Therapeutics

    Boston, MA
    4 days ago
  • Moderna is seeking an Associate Director for Global Regulatory Advertising and Promotion to ensure...  .... You will collaborate with Regulatory Affairs, Legal, Medical, and Commercial teams...  ...requirements and APBL guidance. You will lead PMRT/MRC discussions, support FDA... 

    Moderna

    Cambridge, MA
    23 hours ago
  • SoTalent is seeking an Associate Director, Global Regulatory Affairs to influence global regulatory strategy for innovative therapies. This role is critical in shaping regulatory strategies and ensuring successful outcomes with cross-functional teams. The successful candidate... 

    SoTalent

    Boston, MA
    1 day ago
  • Takeda’s Plasma-Derived Therapies (PDT) R&D Organization is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to guide labeling strategy for US, EU, and CCDS labeling across PDT BU. The role partners with Clinical, Pharmacovigilance, Legal, Scientific... 

    Takeda

    Cambridge, MA
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory Affairs Lead - IND/CTA Submissions. Be the first to apply!