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 2 days ago
Similar jobs that could be interesting for youBased on the Global CMC Regulatory Director — Strategy & Submissions in Convent Station, NJ vacancy
- ...development company based in New Jersey is seeking a professional in Global Medical Affairs. This role requires accountability for... ...leaders to develop sound medical rationale and support regulatory submissions. Join us to make a significant impact in the medical domain....Suggested
- Global Regulatory CMC Manager (Senior Consultant) Duration: 12 Months Max Rate: $50/HR on W2 All inclusive/No Benefits Position... ...will play a key role in developing regulatory strategies, preparing global submissions, managing product lifecycle changes, and collaborating...Suggested
$182k
...@abbvie on LinkedIn, ( Facebook, Instagram ( , X ( and YouTube. ( 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 market...SuggestedLocal areaWorldwideAbbVie
Florham Park, NJ2 days ago- AbbVie in Florham Park, NJ is seeking a Director Regulatory Affairs Global Regulatory Lead to develop and implement global regulatory strategies across product life cycles. You will lead the GRPT, coordinate with LRST and AST, and drive regulatory excellence in a complex...Suggested
- AbbVie seeks a Director Regulatory Affairs Global Regulatory Lead to develop and implement global strategies ensuring market approvals and lifecycle management for assigned products. You will lead the Global Regulatory Product Team and coordinate with AST and LRST to align...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...
- ...opportunity for an Associate Director in the Morris Plains,... ...Director in the Regulatory Affairs CMC Department. The... ...post-authorization submissions for biological substances... ...the Regulatory CMC strategy, content, and... ...contributes to local and / or global process improvements,...Contract workLocal area
Fladger Associates
Morris Plains, NJ4 days ago $140k - $200k
Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on... ...for defining and executing global CMC regulatory strategies for assigned investigational and... ...and deliver scientifically sound, submission ready CMC content using a risk based...Full timeWork at officeLocal area$260k - $295k
Overview Join to apply for the Senior Director, Global Commercial Strategy role at Shionogi Inc. (U.S.) . The Senior Director, Global Commercial Lead... ...payer/reimbursement, health outcomes, clinical, regulatory, and project management. Accountable for ensuring patient...Full timeWork at officeLocal area2 days per week3 days per week- Pacira BioSciences, Inc. is seeking an Associate Director of Regulatory Operations to drive global regulatory strategy and lead submission planning across regions. The role focuses on optimizing processes, ensuring timelines, and leveraging Veeva RIM as a SME to enhance...
- ...variable cost.Job Description• Assist and support regulatory CMC managers in the following activities:• Defining global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory...Immediate start
- .... Lead, guide, and train the CMC team to ensure highly qualified... ...which include, timely submission of Annual Reports, CPP, release... ...to new product launch Manage regulatory correspondence mainly to CDER... ...department. Coordinate with global and local affiliates. Education...Local area
$203k - $267k
...manages, evaluates and implements regulatory projects in support of... ...goals in the area of clinical strategy. The position will play a... ...role's responsibilities may be global, regional, or local based on... ..., including for regulatory submissions documents and HA...For contractorsLocal areaFlexible hours- A leading healthcare company is seeking an Associate Director for Global Supply Planning. You will lead a team to ensure product availability in the fast-paced medical device sector. With over 10 years of operations and supply chain experience, you will drive strategic...
- DLA Piper seeks a Director of Tax to lead the firm's domestic and global tax strategy, governance, compliance, planning, and risk management, coordinating with international... ...to firm leadership on tax matters, including regulatory developments, partner-related tax...
- Pacira BioSciences, Inc. seeks a regulatory affairs leader to manage complex projects and guide strategic decisions. With a focus on non-opioid pain management, you will oversee regulatory submissions and collaborate cross-functionally. The ideal candidate has 10+ years...Flexible hours
- AbbVie in Florham Park, NJ seeks a Director of Health Economics & Outcomes Research (HEOR... ...commercialization teams, accountable for HEOR strategies and delivery for at least one asset or... ...reports and will collaborate with global teams, communicating findings to internal...
- ...Florham Park, NJ, seeks a seasoned HEOR Director to lead development and execution of... ...leadership. You will shape brand/asset strategies, ensure alignment with product plans, and... ...in pharma, with extensive experience in regulatory, HTA, and regulatory landscapes, #J-18...
- 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...
- ...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...
- ...Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible... ...Regulatory Lead (GRL), Associate Director, or Director), in the development... ...preparation and review of regulatory submissions consistent within US and Canada...Full timeLocal area
- HUTCHMED seeks a Sr Director, Regulatory Affairs to establish and lead regulatory affairs globally. You will craft global registration strategies for US and EU, providing decisive regulatory guidance to product teams and lifecycle planning. The role requires a strong track...
$150k - $180k
...Global Trade Compliance Director If you are a compliance professional looking for an opportunity to grow... ...to lead global compliance strategy across the Fluid and Motion Control... ...all FLMC locations. Participate in Regulatory Compliance strategic projects, teams...Local areaHackajob
Florham Park, NJ3 days ago$160.5k - $305k
...Job Description The Director, Health Economics & Outcomes... ...she is accountable for HEOR strategies and execution for at least one... ...skills in a cross-functional global team environment. Ability to... ...Extensive knowledge of the global regulatory, HTA and PR&A landscape, as well...Full timeWork experience placementLocal areaAllergan
Florham Park, NJ2 days ago$174.1k - $287.27k
...this roleThe OpportunityThis is a unique opportunity to build and lead the Global Planning Centre of Excellence (COE) for North America and Latin America. You will define the global planning strategy, governance, and operating model while driving the adoption and...Full timeWork at officeRelocation package$103.6k - $288.6k
...Job Summary: The Associate Director, Global Regulatory Advertising and Promotion will be responsible... ...requirements. Guide promotional strategy as the Regulatory Ad Promo... ...authorities as needed. Prepare regulatory submissions for promotional materials, including...Full timePart timeWork at officeImmediate startWorldwideIQVIA
Parsippany Troy Hills, NJ7 days ago$225k - $275k
...Description OverviewAs Senior Director of Regulatory Affairs - Cluster (North... ...translate Category Regulatory strategies into effective local... ...market risk management, and submission readiness, working in partnership... ..., regulatory pathways, and global dossier expectations; this...Work at officeLocal areaRemote work2 days per week- ...Compliance team and program Directly manage and otherwise lead a global team of compliance professionals Own and oversee export,... ...in a multinational environment with a strong understanding of regulatory compliance Strong understanding of maquila operations and free...
- Associate Director, Global Supply Planning Position overview and responsibilities for AbbVie’s US Medical Device & Aesthetics global supply... ...Global Supply Planning leadership team supporting global supply strategy development and deployment. Motivate, coach, and develop...Full timeContract workTemporary work
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
- regulatory affairs director Convent Station, NJ
- corporate compliance manager Convent Station, NJ
- manager regulatory affairs Convent Station, NJ
- regulatory manager Convent Station, NJ
- head compliance Convent Station, NJ
- regulatory & compliance manager Convent Station, NJ
- compliance manager Convent Station, NJ
- strategic director Convent Station, NJ
- director of strategy Convent Station, NJ