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

Global CMC Regulatory Strategy Lead

Otsuka America Pharmaceutical Inc.

Otsuka America Pharmaceutical Inc. in Atlanta is seeking an experienced CMC Regulatory Strategist to provide regulatory strategy input for investigational and marketed drugs. The role involves developing strategies for CMC-related scenarios, ensuring compliance with global requirements, and preparing essential submissions to regulatory authorities. The ideal candidate will have extensive regulatory experience in drug development processes and strong analytical and communication skills. The position offers robust benefits and competitive compensation. #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global CMC Regulatory Strategy Lead in Atlanta, GA vacancy
  • A leading contract research organization is seeking a CMC Regulatory Affairs Manager to oversee the preparation, review, and submission of regulatory filings related...  ...scientific degree and experience interacting with global health authorities. Join us to drive regulatory... 
    Regulatory
    Contract work

    Katalyst CRO

    Atlanta, GA
    1 day ago
  • Parexel is seeking a Regulatory Affairs Consultant/Senior Consultant to guide complex global clinical development programs through the regulatory landscape with strategy, insight, and collaboration. This role focuses on health authority interactions, submission planning... 
    Regulatory

    Parexel

    Atlanta, GA
    1 day ago
  • $150k - $195k

     ...experienced Associate Director for Technical Operations CMC Strategy. This role involves leading the CMC strategy for small molecules, collaborating...  ...especially in managing contract manufacturers and preparing regulatory filings. Travere offers a competitive salary range of... 
    Regulatory
    Contract work

    Travere Therapeutics

    Atlanta, GA
    1 day ago
  • $96.9k - $135k

    A global supplier of specialty materials is seeking a Regulatory Affairs Manager in Atlanta, GA. This strategic role leads the global regulatory affairs function, ensuring compliance across multiple sectors such as pharmaceuticals and food. Key responsibilities include... 
    Regulatory

    Huber Engineered Materials

    Atlanta, GA
    20 hours ago
  • $172.5k - $222.5k

    A leading internet financial platform company seeks a skilled professional for global fraud risk management. Responsibilities include defining strategies, managing compliance with regulatory standards, and leading fraud detection initiatives. Ideal candidates will have... 
    Regulatory

    Circle

    Atlanta, GA
    1 day ago
  • $150.03k - $224.25k

    Job Summary Provide CMC regulatory strategy input and expertise in the area of investigational, new and...  .../maintained in compliance with global regulatory requirements and guidances....  ...in conjunction with global regulatory lead(s). Prepare, coordinate and/or review... 
    Regulatory
    Contract work
    Temporary work
    Work at office
    Local area
    Flexible hours

    Otsuka America Pharmaceutical Inc.

    Atlanta, GA
    1 day ago
  • Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for Chemistry, Manufacturing...  ...for rare disease therapeutics. The role requires managing global regulatory submissions and team collaborations, necessitating... 
    Regulatory
    Remote job

    Travere Therapeutics

    Atlanta, GA
    1 day ago
  • UCB is looking for a Regulatory CMC Scientist to join our Global Regulatory team. This role, based in Atlanta, GA, involves defining submission strategies and leading CMC regulatory submissions. The candidate should have a robust background in the pharmaceutical industry... 
    Regulatory

    UCB

    Atlanta, GA
    1 day ago
  • $150k - $195k

     ...Associate Director, Technical Operations CMC Strategy is responsible for the creation and...  ...will collaborate closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to...  ...ongoing compliance with applicable cGMP and global regulatory requirements. Provide... 
    Regulatory
    Contract work
    Temporary work
    Remote work

    Travere Therapeutics

    Atlanta, GA
    1 day ago
  • UCB Inc. is seeking a Regulatory CMC Scientist to join our Global Regulatory team based in Atlanta. The role involves defining strategies for CMC submissions and ensuring timely approvals with a focus on collaboration across various teams. A Bachelor's degree is required... 
    Regulatory

    UCB Inc.

    Atlanta, GA
    1 day ago
  • Dolby is seeking a Senior Manager, Global Compensation based in Atlanta, GA. This key role is part of the Total Rewards team, leading the design and implementation of global compensation...  ...will have a background in compensation strategies and data analysis, influencing senior... 
    Local area

    Dolby

    Atlanta, GA
    1 day ago
  • $189k - $246k

     ...Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute comprehensive...  ...collaborating with cross-functional teams and leading regulatory submissions for pivotal...  ...have significant experience with global health authorities, ideally with a... 
    Regulatory
    Remote job

    Travere Therapeutics

    Atlanta, GA
    1 day ago
  • Company Overview Intuit is the global financial technology platform...  .... Within SRCO, the SOX Strategy, Operations & Audit Excellence...  ...Summary We’re looking for a Lead, SOX Program Strategy & Audit...  ...SRCO team. Monitor the evolving regulatory environment (PCAOB, SEC) and... 
    Regulatory
    Work experience placement
    Work at office

    Intuit Inc.

    Atlanta, GA
    3 days ago
  •  ...Importance of the Role Reporting to the Vice President, Global Medical Affairs Strategy and Field, the MSL Team Lead is responsible for the development of the vision,...  ...and track record of complying with industry and regulatory compliance guidelines; ability to apply knowledge... 
    Regulatory

    Sarepta Therapeutics

    Atlanta, GA
    1 day ago
  •  ...for patients We are looking for a Regulatory CMC Scientist to join our Global Regulatory team, based in our Raleigh...  .... About The Role Define the strategy, planning and preparation (writing...  ...communication to key stakeholders. Lead or contribute to ongoing process improvement... 
    Regulatory
    Local area

    UCB

    Atlanta, GA
    1 day ago
  • American Express Global Business Travel is seeking a Manager of Client Management in Atlanta, Georgia. This role leads innovative account management strategies to enhance profitability and client relations within Global Multi-National accounts. The successful candidate... 
    Flexible hours

    American Express Global Business Travel

    Atlanta, GA
    20 hours ago
  • Stripe is seeking an SA Program Manager to own and drive global programs, scoping ambiguous problems, aligning diverse stakeholders, and delivering complex initiatives from strategy through delivery. You will partner with SA leadership and business partners (Strategy &... 

    Doist

    Atlanta, GA
    2 days ago
  • A leading CRO in the pharmaceutical industry is seeking a Regulatory Affairs Manager to lead regulatory strategies and product submissions. The role involves ensuring compliance with regulations across key markets such as the USA and EU. Candidates should have a BS/MS... 
    Regulatory
    Contract work

    Katalyst CRO

    Atlanta, GA
    1 day ago
  •  ...a Senior Payroll and Equity Analyst to provide expertise in multi-country payroll and global equity administration. You will handle payroll processing semi-monthly, ensure regulatory compliance, and support the equity program including equity transactions and reporting... 
    Regulatory

    Manhattan Associates

    Atlanta, GA
    20 hours ago
  • LANDI Global in Atlanta seeks an Operations & Logistics Specialist to manage end-to-end inbound logistics for equipment entering the...  ...Latin America when required. This role emphasizes cost control, regulatory compliance, and continuous improvement across the logistics chain... 
    Regulatory

    LANDI Global

    Atlanta, GA
    1 day ago
  • Avanos Medical in Alpharetta, GA seeks a Senior Regulatory Intelligence Specialist to lead and coordinate the Regulatory Intelligence program. You will monitor global regulatory developments, standards updates, and enforcement trends to support proactive compliance and... 
    Regulatory

    Avanos Medical

    Atlanta, GA
    3 days ago
  •  ...experience in compensation analysis, particularly in a healthcare context. Responsibilities include developing compensation strategies, ensuring regulatory compliance, and providing training to internal teams. Excellent communication skills are essential for this role, which... 
    Regulatory
    Monday to Thursday

    Hunt Corporation

    Atlanta, GA
    3 days ago
  • Southwire Company, LLC is seeking a Vice President, Tax to lead the global tax function, drive strategic tax planning, and oversee all tax...  ...ensure GAAP tax accounting and effective tax rate projections align with corporate strategy. #J-18808-Ljbffr Southwire Company, LLC

    Southwire Company, LLC

    Atlanta, GA
    1 day ago
  • $209.6k - $313.38k

     ...Company Overview Otsuka is a global healthcare company driven by our purpose...  ...align to the broader overall TA strategy determined by the Sr. Director, Franchise Lead CNS Early Assets. Position...  ...with the US healthcare system and regulatory landscape is required for this... 
    Regulatory
    Temporary work
    Local area
    Flexible hours

    Otsuka America Pharmaceutical Inc.

    Atlanta, GA
    9 hours ago
  • $208k - $333k

    Mastercard is seeking a Senior Managing Counsel, Regulatory in Atlanta, Georgia. This role involves leading the MTS Regulatory team, driving compliance programs...  .... The position includes developing regulatory strategies and managing compliance efforts. A range of $208,0... 
    Regulatory

    Mastercard

    Atlanta, GA
    2 days ago
  • Flexport is hiring a Trade Advisory Manager to lead a team of customs and trade advisors and drive growth in a highly regulated global trade environment. You will develop new service offerings, own the long-range plan, and help clients resolve complex trade questions while... 

    Flexport

    Atlanta, GA
    1 day ago
  • $125k - $208.3k

     ...Description Summary The Sourcing Global Commodity Leader - SMR...  ...executing the global commodity strategy for critical large‑scale fabricated...  ...heat exchangers. This role leads strategic sourcing...  ..., supplier financial health, regulatory and trade developments, lead‑... 
    Regulatory
    Long term contract

    GE Vernova

    Atlanta, GA
    4 days ago
  • CMC Regulatory Affairs Manager at Katalyst CRO Responsibilities Lead preparation, review, and submission of CMC sections of regulatory...  ..., variations, renewals) to global health authorities. Provide...  ...alignment with global regulatory strategies and objectives. Proactively... 
    Regulatory

    Katalyst CRO

    Atlanta, GA
    1 day ago
  • $136.3k - $227.1k

     ...those we serve - we care. Role Summary A lead individual contributor role within US...  ...outputs. Key Responsibilities Drive IDP strategy and operationalization — Lead the...  ...standards for quality, access, privacy, and regulatory requirements. Other duties as assigned.... 
    Regulatory
    Work at office
    Remote work
    2 days per week

    McKesson

    Atlanta, GA
    4 days ago
  • $96.9k - $135k

    A major specialty chemical supplier is seeking a Regulatory Manager in Atlanta, GA. This strategic role leads global regulatory affairs across various applications, ensuring compliance and managing risks. Responsibilities include overseeing regulatory documentation, maintaining... 
    Regulatory

    J.M. Huber Corporation

    Atlanta, GA
    20 hours ago

Do you want to receive more vacancies?

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