Global CMC Regulatory Director — Strategy & Submissions
EmergencyMD
EmergencyMD is seeking a regulatory CMC specialist to provide global regulatory support throughout the product lifecycle in Morristown, New Jersey. The role involves managing high-quality CMC regulatory submissions and ensuring timely execution of corporate goals. The ideal candidate should possess a S/Ph.D. degree and 5-10 years of relevant experience in the biotech or pharma industry, with excellent communication skills and the ability to interpret FDA regulations. #J-18808-Ljbffr EmergencyMD
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global CMC Regulatory Director — Strategy & Submissions in Convent Station, NJ vacancy
- HUTCHMED is seeking a (Sr.) Director of Regulatory Affairs to establish and lead... ...role involves supporting the global product team in developing registration strategies for product approvals in both... ...leveraging their expertise, manage submissions, and develop timelines in...Suggested
- ...Aesthetics portfolio. For more information about AbbVie, please visit Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain...SuggestedLocal areaWorldwide
- Allergan is seeking a Director of Regulatory Affairs to lead global regulatory strategies within the therapeutic area. This role requires 7+ years of regulatory experience and involves securing market approvals for products. The ideal candidate will have strong project...Suggested
$199.95k - $242.3k
## Director, Regulatory CMC - Cell TherapyMadison - Giralda - NJ - USFind out... ...strategic direction based on global regulatory guidelines and... ...preparation of CMC submissions while ensuring thoroughness... ...effective global regulatory strategies in coordination with clinical...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Initial Therapeutics, Inc. is seeking a Manager of Regulatory Affairs - CMC. This role involves managing developmental and post-marketing projects... ...regulations. The manager will oversee the preparation of submission documents and lead FDA interactions. The ideal candidate...Suggested
- ...visit Job Description This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, preparing CMC filings and submissions to regulatory applications, regulatory submission timeline...Local area
- Bristol-Myers Squibb is seeking a Director, Regulatory CMC for Cell Therapy in Madison, NJ. In this pivotal role, you will oversee multiple development... ...compliance and strategic direction in alignment with global guidelines. The ideal candidate will have significant...
- ...New Jersey, is seeking a Manager for Regulatory Affairs - CMC. The role involves managing developmental... ...post marketing projects, preparing submission documents, and leading FDA... ...opportunities to influence regulatory strategy and contribute to innovative medicines...
$127.28k - $190.92k
Job Title: Manager, Regulatory Affairs - CMC Job Requisition ID: 1525 Posting Start... ...to "be an innovative global healthcare company contributing... ...team in the preparation of submission documents (e.g., IND, BLA,... ...projects. Execution of Strategy and Submissions: Prepare content...$189k - $236.2k
A leading global company seeks a Director Tax in Morristown, NJ, to oversee all aspects of taxation, ensuring compliance with local and international tax laws. The ideal candidate will have over 5 years of tax experience and strong skills in tax reporting and planning....Local area$242.7k - $404.5k
Daiichi Sankyo US is looking for a Senior Director, Clinical Safety Science to lead global safety strategy across the product lifecycle. This key role oversees a team of Safety Scientists and collaborates with various stakeholders for proactive safety surveillance and...- Merck & Co. is looking for a Senior Director, Clinical Safety Science, to shape and advance global safety strategy throughout the product lifecycle. This leadership role oversees a team of Safety Scientists, ensuring proactive safety surveillance and risk mitigation. The...
- Senior Manager/Director, Regulatory Affairs (Generalist) Are you... ...and established global organizations. We work... ...on client development strategies. No two projects are... ...development pathways, submission strategy, and health... ...milestone activities CMC Regulatory Support, including...
- ...Solstice Mobile, Inc. is seeking a General Manager to oversee the Hydrogen Fluoride segment and drive the global Strategic and Annual Operating Plans. This role, based in Morris Plains, NJ, requires significant travel and strong leadership skills. The ideal candidate...
- ...interpersonal, analytical, and financial modeling skills, with a Bachelor's degree and 6-8 years of relevant experience. This hybrid role enables collaboration across global teams while ensuring timely and accurate financial reporting and analysis. #J-18808-Ljbffr OrganOx Limited
- ...The Senior Manager RA, Global Reg Strategy US & Canada - Immunology is... ...implementation of US and Canada regulatory strategic and tactical... ...Regulatory Lead (GRL), Associate Director, or Director), in the... ...preparation and review of regulatory submissions consistent within US and...Full timeWork at officeLocal area
$184.24k - $276.36k
Job Summary The Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic... ...is responsible for leading regulatory strategy and decision‑making for complex, high‑... ...and support required promotional submissions, including Form FDA 2253, Subpart E/H,...Work at office- ...of patients for generations to come. Regulatory Submission Management acts as a partner for strategic... ...execution of the portfolio, to ensure global Regulatory submissions are scalable,... ...across Regulatory Affairs, bridging strategy and execution while building knowledge...Full timeFor contractorsWork at officeLocal areaWorldwideFlexible hours
$150k - $180k
...for you based in Florham Park, NJ. The Global Trade Compliance Director role offers a highly visible opportunity to lead global compliance strategy across the Fluid and Motion Control... ...all FLMC locations. Participate in Regulatory Compliance strategic projects, teams...Local area- Sanofi is seeking a Global Head of Clinical Data and Business Strategy to drive the strategic roadmap for AI-powered clinical data processes. You'll partner with clinical development teams and execute comprehensive business strategies leveraging emerging technologies....
- A leading construction brand is seeking a Director, Legal to serve as the sole legal advisor. This role requires... ...governance, manage litigation and contracts, and ensure regulatory compliance. The position involves global travel and requires a JD from an accredited law...
LATICRETE
Pine Brook, NJ3 days ago - Scorpion Therapeutics is seeking a Senior Director for Device Quality to provide strategic leadership for quality across... ...systems. This role involves leading Device Quality strategy, ensuring compliance with global device regulations, and improving quality systems to support...
$270k - $300k
Overview The Senior Director Portfolio Strategy and Execution serves as a strategic and operational leader... ...with Commercial, Medical Affairs, Regulatory, Clinical Development, Finance and... ...long‑term brand strategies. Works with global marketing and BD&L on future assets...Full timeTemporary workLocal areaImmediate start$134k - $179k
...Sourcing team is responsible for building and scaling CoreWeave’s global supplier ecosystem to support rapid data center and network... ...reviewed, and managed at scale across CoreWeave’s footprint. Category Strategy & Planning Develop and execute category strategies for dark...Permanent employmentContract workTemporary workCasual workWork at officeFlexible hours$145k - $175k
Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy... ...& Analysis will report to the Senior Director of Financial Planning & Analysis (FP&A).... ...fully support accurate budgeting, timely submissions and effective reporting. Your key...Temporary workWork at officeLocal areaWorldwide2 days per week3 days per week- ...accuracy, and integrity of financial information in support of the Global Commercial, Marketing and Operations organization. This role is... ..., and well-presented P&L, cash flow, and sales outlook for submission to management and global FP&A team. Support financial modeling,...Flexible hours
- The (Sr.) Director, Regulatory Affairs role will establish Regulatory Affairs... ...He or She will support the global product team in the... ...sound global registration strategies for our pipeline which can... ...preparation, approval and timely submission of regulatory filings, including...
$225k - $305k
Sr. Director, US Advertising & Promotion, Regulatory Affairs Field of work: Regulatory & Medical... ...role, you’ll guide the strategy, compliance, and impact... ...OPDP), ensuring timely submissions. Develop and implement... ...and procedures globally is a must. This includes...Work at office$115k - $155k
Job Title: Global Regulatory Compliance Manager Location: Pine Brook, New Jersey Type: Direct Hire Compensation: $115,000.00 - $155,000... ...multiple countries and product lines. Drive global regulatory strategies, coordinate cross-functional councils, and integrate...For contractorsLocal areaRemote work$285k - $315k
Shionogi Inc. in Florham Park, NJ, is seeking a Global Project Leader to provide strategic leadership for global clinical development... ...programs in rare diseases. The role involves driving integrated strategies across the development lifecycle and ensuring successful...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global CMC Regulatory Director — Strategy & Submissions. Be the first to apply!
Related searches
- compliance director Convent Station, NJ
- head compliance Convent Station, NJ
- regulatory manager Convent Station, NJ
- regulatory affairs director Convent Station, NJ
- manager regulatory affairs Convent Station, NJ
- compliance manager Convent Station, NJ
- regulatory & compliance manager Convent Station, NJ
- director of strategy Convent Station, NJ
- director strategy and innovation Convent Station, NJ
- director strategic initiatives Convent Station, NJ