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
- HUTCHMED seeks a Regulatory Affairs CMC Director to lead the regulatory team and develop global CMC strategies to support biologics and chemical drug approvals in the US, EU, and internationally. The ideal candidate will have extensive experience in the pharmaceutical industry...Suggested
- 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
- ...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 approval for product(s) in the assigned therapeutic area. Leads the...SuggestedWorldwide
AbbVie
Florham Park, NJ6 hours ago - ...in Morristown, NJ. In this role, you will contribute to global regulatory strategies for medical device and combination products, collaborating... ...landscapes. The role includes preparing high-quality regulatory submissions and supporting compliance activities. Join us to make a...SuggestedWorldwide
$195.18k - $244.57k
Solstice Advanced Materials is seeking a Director of Global Benefits. This role involves leading the design and management of comprehensive... .... Key responsibilities include developing a global benefits strategy and managing relations with vendors. An ideal candidate will...Local area$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...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$199.95k - $242.3k
...Job Summary The GRS‑CMC Director oversees multiple development... ...as a spokesperson in regulatory engagements.... ...strategic direction based on global regulatory guidelines... ...preparation of CMC submissions, ensuring... ...in global regulatory strategy Leadership experience...Full timeShift work- ...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
- In this position, the Regulatory Affairs CMC Director will lead the international Regulatory... ...support the development of sound global CMC regulatory registration strategies to support HUTCHMED’s pipeline... ...of US and EU CMC-related submission documents for investigational...
- 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...
- IQVIA is seeking an experienced professional to manage large, complex regulatory projects in Parsippany-Troy Hills, New Jersey. You will ensure quality deliverables are met on time and on budget, while providing strategic consultancy regarding regulatory processes. The...
- ...am leading a search for a Senior Director, Global Regulatory Clinical Strategy at a commercial-stage biopharmaceutical... ...Development, Nonclinical, CMC, Commercial, and Executive Leadership... ...experience leading complex regulatory submissions and Health Authority interactions...
- Kaye/Bassman International is leading a search for a Senior Director, Global Regulatory Clinical Strategy. This role focuses on overseeing global regulatory strategies across various clinical and non-clinical programs. The ideal candidate will have 15+ years of experience...
$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- Hatch Global Search is seeking a Tax Manager to oversee tax operations, ensuring compliance at federal, state, and local levels. The... ...position offers a dynamic global environment and opportunities for professional growth in tax strategies. #J-18808-Ljbffr Hatch Global SearchLocal 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$199.95k - $242.3k
Bristol Myers Squibb is seeking a Director, Regulatory CMC to oversee multiple development projects and represent the organization on cross-functional... ...teams. This role is essential in ensuring compliance with global regulatory guidelines and managing the growth of direct...- 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...
- Daiichi Sankyo, Inc. is seeking an Executive Director for Oncology R&D, Global Clinical Lead, to oversee multi-program development and strategic regulatory submissions. The role drives clinical strategy, partners with CROs and senior management, and aligns development with...
- Perrigo Company plc is seeking a Senior Director of Regulatory Affairs for North America. This critical role involves in-market execution and... ...will interface with health authorities, manage regulatory submissions, and collaborate with cross-functional stakeholders to...
- EmergencyMD seeks a professional for regulatory oversight responsibilities including all US regulatory submissions and acting as the liaison with the FDA. A Bachelor's degree in a science or health-related field, or equivalent advanced degree, alongside 6 years of experience...Remote work
- EPM Scientific in Morristown, New Jersey, is seeking a strategic regulatory leader to oversee U.S. regulatory activities for a clinical-stage portfolio. This individual will lead regulatory submissions and serve as the primary liaison with the FDA. The ideal candidate...Work at office
- Position: The Director will direct, manage, and implement regulatory projects in support of company goals across clinical strategy areas. The position plays a major... ...may be global, regional, or local, depending... ...including regulatory submission documents and Health Authority...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...
- ...people’s lives ? The Executive Director, Tax Planning role brings... ...focus of the Novartis corporate strategy. This role will be... ...in close alignment with the global tax strategy. Identify, evaluate... ...application, and the changing regulatory landscape. Ensure all tax aspects...Full timeLocal areaShift work
$150k - $160k
...Senior Manager CMC Regulatory A Partner to Actalent is seeking an experienced... ...Affairs to lead regulatory strategy and execution across both... ..., drive high-quality submissions, and collaborate effectively... ...About Actalent Actalent is a global leader in engineering and...Permanent employmentActalent
Morristown, NJ2 days ago- ...Lead, guide, and train the CMC team to ensure highly qualified... ...activities which include, timely submission of Annual Reports, CPP,... ...new product launch Manage regulatory correspondence mainly to CDER... ...department. Coordinate with global and local affiliates....Local area
Katalyst Healthcares and Life Sciences
Madison, NJ4 days ago - 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
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 manager pharmaceutical Convent Station, NJ
- senior director regulatory affairs Convent Station, NJ
- senior regulatory manager Convent Station, NJ
- sr. manager regulatory compliance Convent Station, NJ
- compliance manager Convent Station, NJ
- regulatory affairs director Convent Station, NJ
- regulatory manager Convent Station, NJ
- regulatory & compliance manager Convent Station, NJ
- director global regulatory affairs Convent Station, NJ