Director, CMC Regulatory Strategy & Global Submissions
Discover International
Discover International is seeking a Director of Regulatory Affairs CMC to oversee CMC regulatory strategies across development and commercial programs in the Boston area. This high-impact role requires a strong background in Regulatory CMC, with responsibilities including major submissions and Health Authority interactions. The ideal candidate will have over 10 years of relevant experience, capable of balancing strategic oversight with detailed execution, and will play a vital role in influencing program strategy and managing regulatory risks. #J-18808-Ljbffr Discover International
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Director, CMC Regulatory Strategy & Global Submissions in Oklahoma City, OK vacancy
- ...well-established, global biotech in the Boston... ...heavily in its regulatory function and is looking... ...to bring in a Director-level hire within... ...Regulatory Affairs CMC. This is a high-... ...of CMC regulatory strategy across both development... ...in major submissions such as INDs, BLAs...Suggested
Discover International
Oklahoma City, OK3 days ago $189k - $246k
...Department: 107000 Regulatory Location: San Diego... ...Position Summary The Director, Regulatory Affairs Strategy is responsible for... ...and executing global regulatory strategies... ...Affairs, Biostatistics, CMC, Quality,... ...requirements. Regulatory Submissions Oversee the preparation...SuggestedTemporary workLocal areaRemote workWeekend workTravere Therapeutics
Oklahoma City, OK2 days ago- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute regulatory strategies for clinical programs. This role... ...in regulatory affairs and a strong understanding of global drug development. The successful candidate will work closely...SuggestedRemote job
$116k - $151k
Department: 107000 Regulatory Location: San Diego, USA... ...Remote Be a part of a global team that is inspired... ...of global regulatory strategies from development through... ...regulatory planning, submission execution, Health Authority... ..., Nonclinical, CMC, Regulatory Operations...SuggestedContract workTemporary workRemote work$132k - $172k
Department: 107000 Regulatory Location: San Diego, USA... ...Remote Be a part of a global team that is inspired... ...Summary The Senior Manager, CMC Regulatory Affairs is... ...global CMC regulatory strategies to support clinical... ...CMC regulatory submissions, managing Health Authority...SuggestedTemporary workRemote workWorldwide- A pioneering biotech company in Massachusetts is seeking an Executive Director of Clinical Quality Assurance to drive global quality strategy and lead compliance initiatives. Candidates should possess 15+ years of experience in the field along with proven leadership in...
- ...Massachusetts is seeking an Executive Director, Head of Medical Writing to lead its medical... ...and development of clinical and regulatory documents to ensure scientific accuracy... ...experience and a proven ability in regulatory submissions. Join us to play a central role in...
- Flywire is looking for a Fraud Risk Director to lead the company's global fraud prevention strategy. This role demands a seasoned professional who can balance customer experience with security as Flywire expands into new markets and payment methods. The ideal candidate...
- ...Executive Director of Global Pharmacovigilance About the Company Forward-thinking... ...of risk management strategies and ensure compliance with all relevant... ...safety data, and ensuring the timely submission of safety reports to regulatory authorities. This role requires...
Confidential
Oklahoma City, OK5 days ago - ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology... ...lead the development and execution of the global regulatory strategy for advertising and promotion across its marketed products....
- ...Executive Director, Global Pharmacovigilance About the Company Pioneering... ...pharmacovigilance strategies and processes to ensure compliance with regulatory requirements. This role involves... ...data, and ensuring the timely submission of safety reports to regulatory...
- ...Massachusetts is seeking a Manager/Senior Manager, Regulatory Affairs to drive key regulatory... ...role involves supporting the timely submission and approval of regulatory submissions while... ...’s degree, and strong competency in global regulatory requirements. Join our team to...
- ...seeking a Senior Manager, Regulatory Affairs to support regulatory strategy and execution across key... ...of regulatory submissions including INDs, amendments... ...closely with Clinical, CMC, Nonclinical, Biometrics... ...interpret evolving FDA and global regulatory guidance relevant...
- Manager/Senior Manager, Regulatory Affairs About Us... ...directly shape development strategy and drive long-term... ...high-quality regulatory submissions while supporting regulatory... ...program teams, CMC, Clinical, Translational... ...Experience supporting global regulatory submissions...
- Life.Church is seeking a Director of Social Media responsible for leading the strategy, execution, and growth of YouVersion’s social media presence. This role involves driving a global social media strategy across various platforms and overseeing the creation of tailored...
- ...Chief Strategy Officer (CSO) About the Company Accomplished medical device company Industry Medical Devices Type Privately... ...materials. Additionally, the role involves extensive travel to global sites to gain a deep understanding of the company's operations...
- Travere Therapeutics is seeking a Senior Director, Program Management in Oklahoma City. This role leads program management for development... ...kidney diseases and collaborates with cross-functional Strategy Teams. Candidates should have extensive experience in biotech or...
- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry... ...tactical support in regulatory activities. This includes global regulatory strategy, managing health authority interactions, and ensuring that...
Confidential
Oklahoma City, OK4 days ago $174k - $262k
Role, Inc. is looking for a Director, Sales Strategy to transform revenue growth and operational excellence. You will lead a team, drive strategic initiatives, and engage with executive leadership. The ideal candidate has 7-10+ years of SaaS sales experience, strong analytical...Remote jobFlexible hours- A leading advisory firm is seeking a Senior Executive Partner in Global CIO Advisory. Responsibilities include managing a portfolio of over 25 members from major organizations, providing strategic solutions, and conducting workshops. Ideal candidates will have over 20...
- ...supplies that are compliant with global regulatory requirements and standards... ...development teams (e.g., CMC teams), the Senior Manager is... ...communications on program strategies and issue management. QA representative... ...of the various R&D directors and VPs as well as external...Temporary workWorldwide
- Travere Therapeutics is seeking a Manager of Regulatory Affairs to provide regulatory leadership for late-stage development programs. This role includes preparing and executing submissions to Health Authorities and ensuring compliance with regulatory requirements. The ideal...Remote job
- ...efficiency, and implement tax compliance strategies for clients. You’ll oversee tax... ...cross‑functional collaboration within a global team. You will guide engagements, manage... ...from planning to closure, and foster solutions that align with regulatory #J-18808-Ljbffr EY
$103.6k - $189.9k
...shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career... ...play a pivotal role in managing and implementing tax compliance strategies for our clients. You will provide comprehensive support in tax...Summer holidayFlexible hours$94k - $150k
...Senior Regulatory Affairs Specialist Job Description Senior Regulatory... ...and preparing regulatory submission documents for agencies such... ...development, labeling, and marketing strategies. Coordinate and prepare... ...Device Licenses—for various global markets. Support cross-...Full timeWork at officeWork visaRelocation package3 days per weekMass Digital Health
Oklahoma City, OK5 days ago$245k - $307.5k
...platform companies, building the foundation of a more open, global economy through digital assets, payment applications,... .... What you'll be responsible for: As the Senior Director, Arc - Agentic Commerce Strategy & GTM, you will define and execute Circle's strategy for...Flexible hours$103k - $183.92k
Position Overview Join our platform strategy team at Autodesk where you will impact developing... ...partnerships. You will report to the Director, Platform Strategy. You will be... ...will inform business direction for our global platform transformation by informing and...Work at office$186.9k - $234k
...architect of Rubrik’s most critical industry partnerships. As a Global Alliances Director, you will orchestrate a massive cross‑functional engine—... ...Veterans: Previous experience executing joint GTM strategies with Tier‑1 vendors such as Pure Storage or Cisco ....Local areaRemote workRubrik
Oklahoma City, OK2 days ago$114.6k - $234.6k
...Job Description The Director for Global Defense - Japan is responsible for leading and growing... ...while operating within Japan’s regulatory, security, and procurement environment... ...ecosystem partners; shapes long-range capture strategy; and ensures secure delivery of...Contract workTemporary workFor contractorsLocal areaFlexible hoursOracle
Oklahoma City, OK3 days ago$186.49k - $278.88k
...an innovative and strategic leader to serve as the Director, U.S. Neuroscience Pipeline & Portfolio Strategy. This individual is responsible for supporting Otsuka... ...brand strategy development, working closely with global and R&D, business development, and commercial teams...Temporary workLocal areaFlexible hoursShift workOtsuka America Pharmaceutical Inc.
Oklahoma City, OK3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, CMC Regulatory Strategy & Global Submissions. Be the first to apply!
Related searches
- compliance director Oklahoma City, OK
- regulatory affairs manager pharmaceutical Oklahoma City, OK
- senior director regulatory affairs Oklahoma City, OK
- senior regulatory manager Oklahoma City, OK
- sr. manager regulatory compliance Oklahoma City, OK
- compliance manager Oklahoma City, OK
- training and compliance manager Oklahoma City, OK
- regulatory affairs director Oklahoma City, OK
- regulatory manager Oklahoma City, OK
- regulatory & compliance manager Oklahoma City, OK