Global CMC Regulatory Strategy Lead
Otsuka America Pharmaceutical Inc.
Otsuka America Pharmaceutical Inc. is seeking a CMC Regulatory Lead in Annapolis, Maryland. This role requires expertise in providing CMC regulatory strategies for biologics and small molecules, ensuring compliance with global regulatory requirements. Candidates should have significant experience in managing submissions and approvals for investigational products. The successful candidate will engage with cross-functional teams and lead regulatory documentation efforts. Benefits include comprehensive medical coverage, 401(k) matching, and flexible time off. #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Global CMC Regulatory Strategy Lead in Annapolis, MD vacancy
- A leading pharmaceutical company in Annapolis, MD is seeking a regulatory affairs professional to support global regulatory strategies and manage drug submissions. This role requires at least 5 years of experience in regulatory affairs or related fields, strong communication...Regulatory
$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...RegulatoryContract workTemporary workWork at officeLocal areaFlexible hours- Jobtailor seeks a senior regulatory leader to develop and implement global regulatory strategy for vaccines and infectious disease programs. You will act as the global... .... You will guide Product Development Teams, lead the Global Regulatory Team, coordinate with FDA...Regulatory
- Parexel is seeking an experienced Global Regulatory Labeling Lead to steer global labeling initiatives across the US, EU, and other markets. You will define labeling strategy, lead governance, and collaborate with cross‑functional teams to ensure compliant, high‑quality...RegulatoryRemote job
- Patient Engagement Lead - Global Clinical Trial Recruitment and Retention Syneos Health is a... ...Full Ownership of Global Recruitment Strategy Own and lead the global patient recruitment... ...meet sponsor expectations, regulatory requirements, and internal quality standards...RegulatoryContract work
- Jobtailor seeks a senior regulatory affairs leader to steer global regulatory strategy for cell and gene therapies in a fast-paced environment. The role focuses on oncology, immune-mediated, and rare disease programs, guiding milestones from expedited designations to post...Regulatory
- ...seeking a Supply Chain Leader in Maryland to execute regional strategies aligned with corporate goals. The role involves leading purchasing, logistics, and performance management while driving compliance with regulatory requirements. The ideal candidate will have experience...Regulatory
- Jobtailor is seeking a Global Regulatory Affairs leader with extensive oncology experience to oversee worldwide regulatory strategy and submissions. The role involves coaching regional... ...regulatory strategies with Directors, and leading staffing and resource planning. You...RegulatoryWorldwide
- Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for product lifecycle management. This senior-level role requires independent work and effective collaboration with cross-functional teams to ensure successful regulatory outcomes....RegulatoryRemote job
- ...oncology pipeline and seeking a Director, Regulatory Affairs CMC to join their growing Regulatory team. This position will lead Regulatory CMC strategy across development-stage biologic... ...exposure and the opportunity to influence global regulatory strategy within a fast-...Regulatory
Scienta
Annapolis, MD1 day ago - AstraZeneca seeks a Regulatory Affairs Director to provide strategic and operational regulatory leadership across development... ...of products. You will serve as GRL or regional lead, shaping clinical strategy and engaging health authorities to improve outcomes. The...Regulatory
- American Express Global Business Travel is seeking a Manager of Client Management in Annapolis, Maryland. This role focuses on enhancing client relationships and growing profitability within a global portfolio. Ideal candidates will have over 5 years of global account...
$146.96k - $219.65k
...Provides critical support in developing global regulatory strategy, planning and execution of global... ...in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements... ...regulatory team (GRL, regional leads, CMC‑RA, labeling, medical writing,...RegulatoryTemporary workWork at officeLocal areaFlexible hours- Parexel is looking for a Feasibility & Strategy Leader to shape clinical development strategies... ...mindset. Responsibilities include leading feasibility analysis, developing persuasive... ...innovation. Join Parexel to make an impact on global clinical trials! #J-18808-Ljbffr Parexel
- ...seeks a Senior Product Manager to own the strategy, roadmap, and lifecycle of MSSR... ...investments and pricing decisions. You will lead cross-functional teams across engineering... ...solutions while monitoring market trends and regulatory changes to shape positioning and product...Regulatory
- ...Workers’ Compensation claims managed by TPAs and to lead a team of claim professionals. The role blends... ...performance. The Director sets direction for claim strategy, supervises reserving, and aligns with regulatory requirements, coaching staff and fostering continuous...Regulatory
- ...MD. This role offers the chance to influence compliance strategies and drive improvements in global life sciences organizations. The ideal candidate will have a proven background in FDA inspections and regulatory strategies, contributing to significant challenges while...Regulatory
- Allegis Global Solutions seeks a DEI Program Manager to advance its North America DEI strategy and drive inclusive outcomes. You will partner with Senior DEI leaders, HR, and... ...alignment with enterprise goals and regulatory requirements. You will design learning programs...Regulatory
- Scienta is seeking a Director, Regulatory Affairs CMC to join their growing Regulatory team. This position plays a key role in advancing their oncology pipeline by leading Regulatory CMC strategy for biologic programs. The ideal candidate will have extensive Regulatory...Regulatory
- Parexel is seeking a Regulatory Affairs Consultant/Senior Consultant to guide global clinical programs through regulatory pathways and health authority interactions. You will lead strategies, oversight of submissions, and cross-functional collaboration across regions from...Regulatory
- Responsibilities Steer global regulatory strategy for cell and gene therapies Shape the regulatory path for oncology, immune-mediated, and rare disease programs Lead strategy across key milestones from expedited designations to post-approval maintenance Drive strategy...RegulatoryFlexible hours
- A global professional services firm is seeking a Property Tax Manager to lead tax strategies and compliance initiatives. This role requires a Bachelor's degree and at least 5... ...consulting experience. You will advise on tax regulatory changes, manage compliance frameworks, and...Regulatory
- Responsibilities Provide global strategic regulatory expertise and oversight Coach and mentor regional and global regulatory leads Partner with Regulatory Affairs Directors aligning innovative regulatory strategies Lead resource planning and recruitment of staff Provide...Regulatory
- McCormick & Company, Incorporated in Hunt Valley, MD, is seeking a VP, Global Packaging and Head of NA Packaging. This role will oversee packaging strategies, lead a global team, and engage with senior leadership on innovation and sustainability initiatives. Candidates...Remote work
$126k - $227k
Copeland is seeking a Director of Network Optimization to lead enterprise-wide efforts in optimizing our global manufacturing and supply chain network. The chosen... ..., conduct scenario analyses, and guide long-term strategies. This fully remote role requires significant...Remote work- Lead the strategic digital and AI partnership with AstraZeneca,... ...embedded in clinical development strategy, portfolio decisions and key... ...data quality and strengthen regulatory readiness. Act as the... ...clinical solutions deployed across global study portfolios. Stay ahead...RegulatoryContract work
- Allegis Global Solutions is seeking a DEI Program Manager to lead the development and execution of its diversity, equity, and inclusion strategy across North America. In this role, you will collaborate with teams to design inclusive programs and influence stakeholder engagement...
- McCormick & Company, Incorporated is seeking a Senior Manager, Global FP&A to support financial reporting and forecasting at our Global Headquarters in Hunt Valley, Maryland. This hybrid role involves collaborating with various departments to enhance analytical capabilities...
- Bausch + Lomb is seeking a skilled Project Manager in Annapolis, Maryland to lead global product development strategy within the R&D Global Portfolio and Project Management team. This vital role involves defining project scope, budget, timelines, and managing risks while...
- Amex GBT is seeking a results‑driven Client/Global Account Manager to lead strategic initiatives for large multinational travel programs in the United States. You’ll partner with cross‑functional teams and senior executives to shape goals, optimize programs, and drive...Remote job
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global CMC Regulatory Strategy Lead. Be the first to apply!
Related searches
- regulatory executive Annapolis, MD
- regulatory law Annapolis, MD
- regulatory accountant Annapolis, MD
- regulatory technician Annapolis, MD
- regulatory contract Annapolis, MD
- regulatory scientist Annapolis, MD
- regulatory engineer Annapolis, MD
- regulatory Annapolis, MD
- food regulatory Annapolis, MD
- axiom regulatory reporting