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

Global Regulatory CMC Lead — Transform Medicines

RXinsider LTD.

Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate CMC regulatory activities across product lifecycles and to develop global strategies that align with business priorities. You will guide product teams, prepare CMC and Quality submissions, and manage multiple projects in a fast-paced environment to bring transformative medicines to patients. The role emphasizes leadership of regulatory strategy, collaboration with stakeholders, and interaction with health authorities #J-18808-Ljbffr RXinsider LTD.

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory CMC Lead — Transform Medicines in Norwood, MA vacancy
  • Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory CMC activities and developing strategies for transformative medicines. The ideal candidate will have at least 8 years in the biotech space, particularly... 
    Regulatory

    Moderna

    Norwood, MA
    13 hours ago
  • Moderna is seeking an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC...  ...and regulatory applications. The role leads interactions with health authorities...  ...and shapes regulatory strategy to deliver transformative medicines. #J-18808-Ljbffr RXinsider LTD.
    Regulatory

    RXinsider LTD.

    Norwood, MA
    13 hours ago
  • $142.5k - $256.5k

    The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating...  ...deliver on bringing a new generation of transformative medicines for patients. Development of...  ...2010, we have aspired to build the leading mRNA technology platform, the infrastructure... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    3 days ago
  • $177k - $278.08k

     ...that unlocks innovation and delivers transformative therapies to patients. By focusing R&...  ...accelerate access to transformative medicines and make a lasting impact on patients...  ...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... 
    Regulatory
    Minimum wage
    Temporary work
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    4 days ago
  • $196k - $269.5k

    Join us as we transform immunology and deliver medicines that help autoimmune patients get their...  ...ambitions, the argenx Global Commercial Team is looking...  ..., Global Indication Lead, Rheumatology.In this key...  ...understanding of the legal, regulatory and commercial environment... 
    Regulatory
    Full time
    Temporary work
    Work at office
    Remote work

    argenx

    Boston, MA
    1 day ago
  • $183.8k - $330.3k

     ...Program Implementation Lead to shape and...  ...robotics strategy across CMC manufacturing...  ...(CSV), and regulatory compliance requirementsPotential...  ...of a high-growth, transformational company that is...  ...days, sabbatical, global recharge days, and...  ...to reimagine how medicines are created and... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    2 days ago
  • Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop global strategies in alignment with business priorities. You will guide product teams and prepare CMC/Quality regulatory submissions... 
    Regulatory

    BioSpace

    Norwood, MA
    4 days ago
  • $142.5k - $256.5k

    Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC...  ...projects to support the delivery of transformative medicines. Key Responsibilities Develop and implement...  ...with health authority guidelines. Lead regulatory CMC discussions and... 
    Regulatory

    Moderna

    Norwood, MA
    15 hours ago
  • $142.5k - $256.5k

     ...advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline...  ...into actionable program, regulatory, and supply decisions....  ...What You’ll Do:Define and lead phase-appropriate stability...  ...within cross-functional CMC team structures.Experience... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home
    Worldwide

    Moderna Therapeutics

    Norwood, MA
    1 day ago
  • $130.8k - $209.4k

     ...recommendations, and regulatory support for...  ...-facing stability lead who partners closely...  ...cross-functional CMC teams to align study...  ...stability guidance and global regulatory...  ...of a high-growth, transformational company that is Bold...  ...to reimagine how medicines are created and delivered... 
    Regulatory
    Permanent employment
    Work at office
    Work from home

    Initial Therapeutics, Inc.

    Norwood, MA
    4 days ago
  • $145.9k - $234.2k

     ...configurations and function transforms to standardize...  ...sustained compatibility and regulatory compliance.Here’s What...  ...our US benefits and global well-being resources...  ...aspired to build the leading mRNA technology platform...  ...to reimagine how medicines are created and delivered... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    1 day ago
  • $121.6k - $194.5k

     ...across Moderna's CMC organization. This...  ..., or similar transformation and warehouse tooling...  ..., sabbatical, global recharge days, and...  ...aspired to build the leading mRNA technology...  ...to reimagine how medicines are created and...  ...of the work and regulatory requirements, only... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    4 days ago
  • Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory... 
    Regulatory

    Katalyst CRO

    Boston, MA
    3 days ago
  • $182k - $275k

    Company OverviewRhythm is a global, commercial-stage biopharmaceutical...  ...company committed to transforming the lives of patients living...  ...neuroendocrine diseases. We develop medicines for previously untreatable...  ...-based, and compliant regulatory CMC deliverables for assigned program... 
    Regulatory
    Work at office

    Rhythm Pharmaceuticals

    Boston, MA
    3 days ago
  • $109.2k - $174.6k

     ...Maintenance Excellence & AI Transformation will serve as the global technical champion...  ...operations. This role will lead enterprise initiatives focused...  ...digital innovation, regulatory compliance, asset lifecycle...  ...infrastructure to reimagine how medicines are created and delivered... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    4 days ago
  • $212k - $333.19k

     ...that unlocks innovation and delivers transformative therapies to patients. By focusing...  ...worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device...  ...prospective and proactive implementation. Globally influence and serve as a key opinion... 
    Regulatory
    Minimum wage
    Full time
    Temporary work
    Local area
    Worldwide
    Night shift

    Takeda

    Boston, MA
    2 days ago
  • $136.51k - $204.77k

     ...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead...  ...portfolio of alpha-emitting, tumor-targeted medicines, shaping IND-enabling plans and building...  .... IND/IMPD Readiness: Lead CMC regulatory strategy; guide and contribute to authoring... 
    Regulatory
    Hourly pay
    Temporary work
    Boston, MA
    10 days ago
  • $177k - $278.08k

     ...unlocks innovation and delivers transformative therapies to patients. By...  ...worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization,...  ...regulatory CMC strategy and leads the execution of regulatory CMC... 
    Regulatory
    Minimum wage
    Temporary work
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    4 days ago
  • $238k - $374k

     ...that unlocks innovation and delivers transformative therapies to patients. By focusing R...  ...worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination...  ...Japan, China).How you will contribute:Leads and develops a team of regulatory leaders... 
    Regulatory
    Minimum wage
    Temporary work
    Work at office
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    4 days ago
  • $224.9k - $404.6k

     ...for managing a team of CMC experts that prepare and...  ...correspondence and regulatory applications. This position...  ...in their portfolio and lead and support all...  ...why our US benefits and global well-being resources are...  ...infrastructure to reimagine how medicines are created and... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    4 days ago
  • $145.9k - $234.2k

     ...architecture that makes CMC data usable,...  ...patterns for ingesting, transforming, and serving data...  ...days, sabbatical, global recharge days, and...  ...to build the leading mRNA technology platform...  ...to reimagine how medicines are created and...  ...of the work and regulatory requirements, only... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    4 days ago
  •  ...Associate Director, Regulatory Affairs CMC Founded over a decade ago...  ...CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human...  ...collaboration with CMC and global development teams, and with... 
    Regulatory
    Contract work
    Remote work

    CRISPR Therapeutics

    South Boston, MA
    3 days ago
  • $154.4k - $242.55k

     ...you to shine? Join us as Global Biomarker Lead, Inflammation, GI2 TAU based...  ...GI2 TAU.At Takeda, we are transforming the pharmaceutical...  ...and support translational medicine goals of the assigned programs...  ...and documents submitted to Regulatory Agencies.• Establish and maintain... 
    Regulatory
    Minimum wage
    Temporary work
    Local area

    Takeda

    Boston, MA
    4 days ago
  • $192.4k - $302.39k

     ...you to shine? Join us as a Global Medical Lead, Nephrology in our Cambridge...  ...office.At Takeda, we are transforming the pharmaceutical industry...  ....g., Clinical, Commercial, Regulatory, PV, Health Economics and Outcomes...  ...in biopharmaceutical medicine, with demonstrated experience... 
    Regulatory
    Minimum wage
    Temporary work
    Work at office
    Local area
    Remote work

    Takeda

    Boston, MA
    4 days ago
  • $128.55k - $222.82k

     ...for defining and executing the global strategy for tuning,...  ...operational efficiency, and regulatory defensibility.Position Responsibilities...  ...by downstream controls.Lead recalibration initiatives in...  ...forums on analytics strategy and transformation progress.Required Qualifications... 
    Regulatory
    Full time
    Temporary work
    Local area
    Flexible hours

    John Hancock

    Boston, MA
    1 day ago
  • $212k - $333.19k

     ...as a Senior Director, Global Program Leader - Oncology...  ....At Takeda, we are transforming the pharmaceutical industry...  ...asset strategy and leads all development and...  ...simultaneously driving regulatory approval as well as launch...  ...Sciences (CMC) Subteam, etc. to the... 
    Regulatory
    Minimum wage
    Temporary work
    Work at office
    Local area
    Remote work
    Night shift

    Takeda

    Boston, MA
    4 days ago
  • $163.5k - $281.6k

     ...to discover and deliver life-changing medicines, strengthen how health is understood and...  ...strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies...  ...commercialization, ensuring compliance with global health authority requirements.Job... 
    Regulatory
    For contractors
    Work at office
    Flexible hours

    Eli Lilly and Company

    Boston, MA
    4 days ago
  • $167k - $300.7k

     ...and experienced Director, CMC Stability to lead an end-to-end stability function...  ...timely CMC decisions, regulatory filings, and product lifecycle...  ....Strong knowledge of global stability expectations and...  ...infrastructure to reimagine how medicines are created and delivered,... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    1 day ago
  • $238k - $374k

     ...the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused...  ...major regions (e.g., US, EU, Japan, China).ACCOUNTABILITIES Leads and develops a team of regulatory leaders and subject matter... 
    Regulatory
    Minimum wage
    Temporary work
    Local area
    Remote work

    Takeda

    Boston, MA
    4 days ago
  • $328k

     ...Summary:The Executive Medical Director, Global Medical Lead (GML), Pain is a critical leadership...  ...area and disseminate new information to transform clinical trends and emerging data into...  ...) for pipeline therapies and marketed medicines Regional Medical and Cross Functional... 
    Full time
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    23 hours ago

Do you want to receive more vacancies?

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