Global Submissions Lead - Regulatory Ops Leader
BioSpace, Inc.
BioSpace is seeking a Global Submission Lead based in Morristown, NJ / Cambridge, MA. This role involves planning and coordinating worldwide regulatory submissions to support product development. You will lead submission management activities, ensure compliance with global guidelines, and maintain vendor oversight. The ideal candidate has a Bachelor's degree in regulatory affairs or life sciences, along with over 5 years of relevant experience in the pharmaceutical sector. Knowledge of FDA and EU regulations is required, alongside strong communication and leadership skills. #J-18808-Ljbffr
- ...Location: Morristown, NJ / Cambridge, MA. Job title: Global Submission Lead About The Job As Global Submission Lead within our R&D team , you... ...responsible for the planning, coordination, and tracking of regulatory Priority portfolio and Integration submission activities...RegulatoryWorldwideFlexible hours
- ...team is involved in developing regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in the... ...products. We are an innovative global healthcare company with one purpose... ...remit, as needed Regulatory Submissions & Operations Leads submission...RegulatoryLocal area
- ...Sanofi is seeking a Global Submission Associate in Morristown, NJ to facilitate the coordination of lifecycle submissions for its global... ...standards. Ideal candidates will possess a Bachelor’s degree in regulatory affairs or a related area along with over three years of...Regulatory
- ...US HEOR Oncology & Rare Team Lead Location Cambridge (US) / Morristown... ..., ensuring alignment with Global HEVA strategy. Partner with... ...Ensure scientific rigor and regulatory compliance across all HEVA... ...research partners and key opinion leaders to advance HEVA science....Regulatory
$210k
...Strategy and Cross-Organization Excellence Lead Location: Cambridge, MA or Morristown, NJ... ...leadership role reporting to the Global Head of Finance, Specialty Care. The role... ...launches, partner with Commercial, M&A and Regulatory to ensure launch readiness, and support launch...Regulatory- ...Lonza is seeking a Head of Global Trade in Morristown, TN. This role involves setting strategic direction, overseeing operational execution of global trade, and leading a team of 4–6 trade specialists. The ideal candidate will possess expertise in international trade regulations...
- ...Lead Credentialing Specialist (Travel to other sites expected) Purpose Participates... ...accompanying documentation, to ensure files meet regulatory requirements. 20% Documents and tracks... ...for accuracy and completeness before submission. Routes the credentials files to the...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsFor subcontractorWork at officeFlexible hours
- ...REPORTS: None EFFECTIVE DATE: 6/1/2025 Position Overview The Shift Lead role at Spotless Brands is an operational support position... ...and responsibilities) Must meet all required certification and regulatory compliance standards applicable to the role as defined by federal...RegulatoryFull timeLocal areaShift workAfternoon shift
- ...Job Title Global Labeling Strategist Location: Morristown, NJ /... ...Strategy is responsible for leading or co-leading the development... ...SmPC), ensuring alignment with regulatory requirements and Sanofi\'s product... ...value. Assist in labeling submissions, regulatory queries, and...RegulatoryLocal area
- ...Sanofi is looking for a Global Labeling Strategist in Morristown, TN. This role involves leading the labeling strategy for products, ensuring regulatory compliance, and collaborating with various teams in R&D. The ideal candidate should possess a strong background in...Regulatory
- ...Sanofi is seeking a Global Project Head for Solid Tumor Antibody Drug Conjugates (ADCs) based in Morristown, NJ. This position involves driving clinical development strategy and collaborating with cross-functional teams to ensure successful product outcomes. Ideal candidates...
- ...Keystone Distinction Group in Morristown, TN is seeking a Senior Controller to lead an elite accounting team and oversee critical financial operations. This role includes managing the monthly financial close processes and implementing an upcoming ERP system. The ideal...Flexible hours
- ...Job Title Global Quality Auditor Location Morristown, NJ About The Job Join a global network... ...Practices (GVP). Acts as a lead auditor or co‑auditor, in accordance with... ...Clinical Practices. Deep knowledge of global regulatory requirements and standards. Strong understanding...RegulatoryWorldwide
- ...Cellebrite in Morristown, Tennessee is seeking a Senior Organizational Development Manager to lead cross-company OD practices and support specific OD needs. You will collaborate with various stakeholders to initiate and execute OD and Learning initiatives, making a tangible...
- ...Today, Lonza is a global leader in life sciences operating across three continents. While we... ...Europe. This expert-level role ensures full regulatory compliance, drives cost‑optimization... ...functions. The Head of Global Trade leads and develops a small global team of trade...RegulatoryFull timeTemporary workWork experience placement
- ...Job Title Digital Consumer Experience Strategy & Research Lead Location Morristown, NJ Overview Join the digital engine driving Sanofis... ...Minimum 5+ years of hands‑on CX/UX strategy in a large global enterprise, agency, consulting or start‑up/scale‑up in the context...For contractorsShift work
- Spotless Brands is seeking an Assistant Site Manager in Morristown, TN to assist the Site Manager in daily operations and team leadership. This role focuses on delivering exceptional customer experiences and supports team training and supervision. The ideal candidate will...
- ...CapstoneONE Search is representing a leading manufacturing organization seeking a Production Supervisor. This role involves coordinating activities on the production floor, ensuring quality standards, and continuous improvements. The ideal candidate has over 4 years of...
$123.4k - $156.63k
...Prepare and present written/oral reports to senior management setting forth all issues influencing evaluation and recommending reserves. Lead and negotiate high severity claims through resolution. Evaluate and assess exposure, trends and impacts both at an individual claim...Temporary workWork experience placement- ...Sonic Drive-In is looking for an experienced Restaurant General Manager in Morristown, Tennessee. This role involves leading a team, driving profitability, and ensuring exceptional guest experiences in a fast-paced environment. You will manage cash control, recruit staff...
- ...A leading manufacturing company is seeking a Team Lead to oversee production teams in Morristown, TN. The role involves ensuring safety, quality, and production goals while managing performance and training of team members. The ideal candidate should have a High School...Night shiftRotating shift
- ...A leading biopharma company in Morristown, TN, is seeking a Digital Consumer Experience Strategy & Research Lead. This role involves delivering a comprehensive consumer experience strategy, leading cross-functional teams, and driving strategic implementation of CX initiatives...
- ...National-Fitness in Morristown, TN is seeking a Team Lead to drive club success and profitability while delivering exceptional member service. You will oversee the guest experience and support the leadership team in creating a clean and enjoyable environment for members...
$80k - $110k
...Gensler is seeking a Project Architect to lead a team that delivers architectural projects from concept to completion in Morristown, Tennessee. The ideal candidate will have a Bachelor’s or Master’s degree in Architecture, over 8 years of experience in a commercial design...- ...A leading food company in Morristown is seeking a Sanitation Manager responsible for managing plant sanitation and regulatory compliance. The ideal candidate will oversee sanitation procedures, lead a 3rd party sanitation team, and develop strategic business plans. A BA...Regulatory
$230k - $400k
...infrastructure markets. We are looking for a Client Strategy & Engagement Leader for Business Strategy & Transformation that will serve as the... ...translates client needs into actionable consulting solutions, leads pursuit and proposal activities, and helps clients move from the...Full timeContract workWork experience placementWork at officeLocal area- ...quality audio support for live events. The role necessitates strong technical skills and attention to detail. Responsibilities include leading audio implementation, mixing live sound, and maintaining audio inventory. Candidates must have professional digital mixing...Live in
- Sanofi is seeking a Continuous Improvement & Performance Manager to support the R&D team in enhancing business processes through data and technology. This role emphasizes driving compliance in quality documentation management and establishing robust training strategies...Flexible hours
- ...administration activities. This position ensures compliance with regulatory standards and provides leadership support for post-award... ...grants.gov and eRA Commons. Responsibilities include managing grant submissions and optimizing processes for compliance. #J-18808-Ljbffr...Regulatory
- ...Spotless Brands LLC is seeking a Shift Lead in Morristown, TN, to support site operations and enhance team performance. This role does not entail managerial responsibilities but focuses on executing daily operations, directing workflows, and ensuring customer service...Full timeShift work
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