Regulatory Submissions Coordinator - Dossiers & Publishing
Allergan
Allergan in Florham Park, NJ is looking for an Associate in Regulatory Affairs Submission Management. This role involves managing low to medium impact submission projects with many cross-functional teams. Key responsibilities include overseeing submission processes, coordinating with vendors, and ensuring high-quality compliance with regulatory standards. Qualified candidates should possess a Bachelor’s degree and at least two years of pharmaceutical experience, with preferred knowledge in publishing software. The position follows a hybrid work schedule. #J-18808-Ljbffr Allergan
- Job Description Associate, Regulatory Affairs Submission Management , manages low... ...prepares content planners for publishing, interfaces with... ...delivery of high-quality dossiers that meet regulatory technical... .... Expedites, manages, and coordinates multiple concurrent activities...RegulatoryTemporary workWork at office
$48 - $70 per hour
Shionogi Inc. seeks a Senior Regulatory Operations Associate in Florham Park, NJ, to lead the preparation and submission of regulatory documents through various health authorities including the FDA and EMA. Candidates should have a Bachelor's degree and 3-4 years of pharmaceutical...RegulatoryHourly pay$75k - $108.33k
Job Title: Global Submission Associate Location: Morristown... ...Submission Associate coordinates lifecycle submissions... ...GRA focal points and publishing partners to ensure... ...documentation to regulatory health authorities according... ...: US, Canada, or EU. Dossier assembly and...RegulatoryFull timeLocal area- ...We are seeking a detail-oriented and highly organized Regulatory Coordinator to join our team in a fast-paced pharmaceutical environment. This... ...including face to face FDA Meetings o Regulatory submission coordination and tracking in eSub "Submission Booking System...RegulatoryContract workWork at office
- ...Role We are seeking an experienced IRB Coordinator Consultant to join the Vitalief team as... ..., and communications. Review protocol submissions for completeness and accuracy; recommend... ...deliberations and decisions. Provide regulatory and methodological guidance to investigators...RegulatoryContract workFor contractorsWork at office
$122.25k - $176.58k
...Job title: Global Submission Lead ~ Location: Morristown... ...for the planning, coordination, and tracking of regulatory Priority portfolio and Integration... ...expertise on all dossier formats, standards,... ...thorough understanding of publishing tools and processes....RegulatoryWorldwideFlexible hours$25 - $27 per hour
...Shipping & Receiving Coordinator Join Weiss-Aug – A Leader in Precision Manufacturing and Innovation Be part of a company that'... ...efficiently through the facility while meeting quality, customer, and regulatory requirements. The position works closely with Production,...RegulatoryHourly payTemporary workWork at officeLocal areaWorldwideFlexible hours$48 - $70 per hour
Overview This role will lead in the preparation and submission of electronic regulatory documents through the FDA, EMA, MHRA, and Health Canada Electronic... ...laws and regulations. The scope of this role includes publishing regulatory documents, managing document tracking and...RegulatoryHourly payFor contractorsLocal area- Initial Therapeutics, Inc. is seeking a Global Regulatory Strategist in Morristown, NJ to develop regulatory strategies in oncology.... ...collaboration with clinical and commercial teams and ensuring timely submissions to Health Authorities. The ideal candidate has substantial...Regulatory
- A global health company is seeking a Global Regulatory Lead to support the regulatory strategy for new drugs and medical devices. This role involves managing submissions like INDs and NDAs, reviewing product labeling for compliance, and offering regulatory insights throughout...Regulatory
$55k - $65k
Surplus Lines Tax Coordinator page is loaded## Surplus Lines Tax Coordinatorremote type: Hybrid... ...status* Communicate changes in state regulatory requirements to manager and impacted... ...state audits by coordinating document submission and maintaining state communication files...RegulatoryWork experience placementWork at officeLocal area- Sanofi is seeking a Global Submission Lead to oversee regulatory submission planning and coordination. This role involves ensuring that all submissions meet regulatory standards and are delivered on time. The successful candidate will collaborate across teams and manage...Regulatory
- A leading company in regulatory compliance is seeking a Regulatory Compliance Specialist for a fast-paced role in Parsippany, NJ. The position involves supporting compliance processes related to ingredient disclosure and Safety Data Sheets, along with collaboration across...Regulatory
- A strategic workforce solutions provider in Parsippany-Troy Hills is seeking a Regulatory Specialist. Responsible for ensuring product registration accuracy and supporting regulatory documentation processes. The ideal candidate will have at least 2 years of experience,...Regulatory
- A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing, project management, and collaboration with product teams to ensure high-quality deliverables...Regulatory
- ...email me your resume and contact number. Regulatory Compliance Specialist Location:... ...Diversion tabulation. Contribute to FDA-ACE submissions. Maintain various databases, including... ...submission structures via web portals or dossiers. High attention to detail. Strong database...Regulatory
- ...Regulatory Compliance Specialist Integrated Resources, Inc is a premier staffing firm... ...tabulation Support activity for FDA- ACE submissions Database Management Support... ...regulatory submissions via web portal and/or dossier ~ High attention to detail ~...Regulatory
- ...Web Coordinator - Digital BP About VDart: VDart is an emerging global information technology staffing provider with expertise in Enterprise... ...queue to align with Commercial objectives and Legal/Regulatory compliance concerns. Specific duties include: a. Coordinate asset...RegulatoryFor contractors
- ...Requirements 8-10 years of scientific or regulatory writing experience 5+ years of experience... ..., and other writing tools Experience with publishing regulatory documents; interacting with Health Authority related submissions Masters or PhD in molecular biology, oncology...RegulatoryFlexible hours
- ...Village is looking for a motivated and team-oriented Per-Diem MDS Coordinator to join our team. As a member of our team, the MDS... ...records Ensure all MDS are in compliance with State and Federal regulatory requirements Participate in developing/updating/reviewing/...RegulatoryDaily paidShift workDay shift
$38 - $60 per hour
...MDS Coordinator Join our team at Spring Grove Rehabilitation and Healthcare Center as an MDS Coordinator. Proudly supported by Marquis... ...and accurate MDS assessments. Verify compliance with regulatory requirements and deadlines. Supervise MDS data entry and transmission...RegulatoryFull timeLocal areaMonday to Friday- ...in patient-centered outcomes research, HEOR strategy, and regulatory submissions, with responsibilities spanning both cash-pay and reimbursed... ...real-world evidence studies, economic modeling, and payer dossier to support product approval, market access, reimbursement,...RegulatoryTemporary workWork experience placement
- Overview About the Role Responsible for planning, coordinating, and evaluating the performance improvement (PI) program for the Division... ...Trauma. Responsible for maintenance of compliance with all regulatory agency requirements (American College of Surgeons, -Committee...RegulatoryTemporary workFlexible hours
- ...MDS Coordinator At Complete Care at Orange Park, we believe great care starts with a great team. Our residents aren't just patients... ...completeness of MDS assessments to support resident care planning and regulatory compliance. ~ Stay updated on changes in regulations...RegulatoryFull time
- ...of our extended family. That's why we're looking for an MDS Coordinator who's ready to lead with compassion and make a meaningful impact... ...of MDS assessments to support resident care planning and regulatory compliance. ~ Stay updated on changes in regulations related...RegulatoryFull timePart time
- ...biopharmaceutical company is looking for an Associate Director of Regulatory Affairs to lead the regulatory strategies for Chemistry,... ..., and Controls (CMC). You will prepare and manage regulatory submissions while collaborating with internal departments to ensure success...Regulatory
- ...Head of Regulatory Affairs About the Company Respected provider of top-quality services Industry Consumer Services Type... ...affairs, with a proven track record in regulatory strategy, submissions, and compliance. Strong leadership skills and the ability to...Regulatory
- ...Sr. Regulatory Associate Ability to interpret, apply, and implement regulations and guidance... ...objectives. Develop and communicate submission strategies to the cross-functional... ...regulatory submission. Responsible for coordinating responses to Regulatory agency questions...RegulatoryWork at office
- ...Regulatory Specialist IRI believes in commitment, integrity and strategic workforce solutions. Integrated Resources, Inc., is... ....g., affiliate requests, technical documentation, regulatory submissions). This individual will, also, be responsible to monitor and...Regulatory
$100.9k - $141.29k
...Case Management Coordinator The primary purpose of the Case Management Coordinator position is to coordinate the patient's progress... ...effective care. He/she is responsible to ensure compliance with regulatory standards related to level of care determinations,...RegulatoryTemporary workWork experience placementImmediate startFlexible hours
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