Regulatory Submissions Documentation Specialist
$40 - $57 per hourShionogi Inc. (U.S.)
Shionogi Inc. (U.S.) is looking for a candidate to support their Regulatory Operations team. This role involves the preparation and quality control of submission-related documentation, managing correspondence with health authorities, and overseeing documents stored offsite. The ideal candidate will have experience with Microsoft Word, Adobe Acrobat, and Veeva RIM. The hourly rate for the position is between $40 and $57, commensurate with skills and experience. #J-18808-Ljbffr Shionogi Inc. (U.S.)
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Submissions Documentation Specialist in Florham Park, NJ vacancy
$40 - $57 per hour
Shionogi Inc. is looking for a candidate to support their Regulatory Operations team in Florham Park, New Jersey. This role requires assisting in the preparation of submission documentation, including document formatting and managing materials for health authorities. The...RegulatoryHourly pay$40 - $57 per hour
This role will support the Regulatory Operations team with the preparation of submission related documentation for electronic submission. The scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions...RegulatoryHourly payLocal area- Sanofi in Morristown, NJ seeks a Global Submission Manager to oversee global regulatory submissions within the GRA portfolio. You will coordinate with Global Regulatory Teams, Submission Leads, and cross‑functional colleagues to plan, execute submissions in alignment with...Regulatory
- HUTCHMED is seeking a (Sr.) Director of Regulatory Affairs to establish and lead the Regulatory Affairs function. This role involves... ...provide regulatory guidance leveraging their expertise, manage submissions, and develop timelines in coordination with global partners....Regulatory
- 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...Regulatory
- Sanofi is seeking a Regulatory Strategist to lead the development and execution of regulatory strategies in Morristown, NJ. You will work within the R&D team to support submissions and ensure compliance with US, EU, and global requirements. The ideal candidate has a scientific...RegulatoryFull time
- 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...RegulatoryWork at office
- 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...RegulatoryRemote work
- A leading pharmaceutical firm in New Jersey is seeking a Regulatory Affairs Associate I to manage low- to medium-impact regulatory submission projects. You will be responsible for coordinating submission activities, ensuring compliance with regulatory standards, and working...RegulatoryContract work
- ...peers and cross-functional teams. Maintain solid knowledge of Regulatory Agency organizations. Apply knowledge and experience to increasingly... ...stakeholder timelines and objectives. Develop and communicate submission strategies for the project team, including strategies for...RegulatoryWork at office
- ...work on complex projects. The position involves engaging with external medical and scientific leaders to develop sound medical rationale and support regulatory submissions. Join us to make a significant impact in the medical domain. #J-18808-Ljbffr 360 IT ProfessionalsRegulatory
- Sanofi is seeking a Global Submission Manager in Morristown, NJ to manage all submission types for the GRA portfolio. The role includes representing GRO on Global Regulatory Teams, prioritizing workload, and negotiating timelines with stakeholders. Close collaboration...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
Integrated Resources
Parsippany, NJ4 days ago $130k - $165k
Alfasigma S.p.A. in Morristown, NJ is hiring for a regulatory position focusing on low complexity programs. Responsibilities include developing regulatory strategies, supporting IND/CTA submissions, and ensuring compliance with regulatory requirements. The ideal candidate...Regulatory- ...in Morristown, NJ and Cambridge, MA is seeking a Regulatory Strategist to shape global regulatory strategy for... ...you will provide regulatory input, lead briefing documents, manage timelines, and coordinate submissions (NDA/BLA/MAA, IND/CTA) with cross‑functional partners...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
- Breckenridge Pharmaceutical, Inc. is seeking a Regulatory Operations professional to oversee FDA eCTD submissions, NDAs, INDs, ANDAs and related documents, ensuring timely, compliant publishing. You will develop and maintain templates, track regulatory records, and collaborate...RegulatoryFlexible hours
- Global Submission Manager Location: Morristown, NJ Overview The Global Submission Manager oversees global regulatory submissions for the GRA portfolio, applying expertise across all submission... .... Specialized expertise in eCTD, document management systems, publishing tools,...Regulatory
$90k - $125k
...seeking a dedicated and accomplished Senior Document Controller for the Hudson Tunnel... ...external partners to coordinate document submissions, reviews, and approvals, ensuring the review... ..., consistency, and compliance with regulatory expectations and project guidelines....RegulatoryFull timeWork at office- Job Title: Global Submission Manager Location: Morristown, NJ About the job The Global... ...standard to complex. Represent GRO on Global Regulatory Teams (GRTs) for assigned products, per... .... Expertise in the eCTD process, document management environments/systems, publishing...Regulatory
- Sanofi seeks a Lead, R&D Document Standards & Integrated Services in Morristown, NJ (and Cambridge, MA) to drive governance and standardization of regulatory documents across the global R&D organization. You will partner across Clinical, Regulatory, Quality and Digital...Regulatory
- ...Responsibilities Define and lead the regional regulatory execution priorities Translate Category regulatory strategies into actionable... ...Health Canada Own cluster regulatory delivery performance and set submission priorities Maintain relationships with health authorities...Regulatory
Jobtailor
Convent Station, NJ3 days ago - ...Jersey. Responsibilities include creating reports, updating tickler dates, and contacting borrowers to obtain necessary financial documentation. The ideal candidate will work closely with Loan Officers and provide timely resolutions on past due loans while maintaining...
Valley National Bancorp
Convent Station, NJ2 days ago - ...clients’ success. Job Description The Regulatory Specialist will be responsible for activities to ensure... ...tracking, and processing of regulatory documentation (e.g., affiliate requests, technical documentation, regulatory submissions). This individual will, also, be...Regulatory
Integrated Resources
Parsippany, NJ4 days ago $123.93k - $160.38k
...patients for generations to come. Regulatory Submission Management acts as a partner for... ...regulatory submissions teams, providing specialist guidance on regulatory submissions requirements... ...preparation of high-quality documents for internal stakeholders. Author...RegulatoryFull timeFor contractorsWork at officeLocal areaFlexible hours- ...pharmaceutical consultancy in Madison, NJ, seeks a Scientific Writer for Translational Development. The role involves writing regulatory documents, collaborating with scientists, and ensuring timely publication of outputs. Requires a Masters or PhD in relevant fields and...Regulatory
- Bristol Myers Squibb is seeking a Director, US Regulatory Lead to oversee regulatory strategy and execution for the Immunology and Cardiovascular... ...will manage Health Authority interactions and lead NDA submissions. With responsibilities that include providing strategic...Regulatory
- ...marketing activities which include, timely submission of Annual Reports, CPP, release of... ...prior to new product launch Manage regulatory correspondence mainly to CDER, FDA, User... ...harmonization process of regulatory documentation at all manufacturing sites. ctive...RegulatoryLocal area
Katalyst Healthcares and Life Sciences
Madison, NJ1 day ago - Perrigo Company plc is seeking a Senior Director of Regulatory Affairs for North America. This critical role involves in-market execution... ...will interface with health authorities, manage regulatory submissions, and collaborate with cross-functional stakeholders to ensure...Regulatory
- Bayer CropScience Limited is seeking a Director of Regulatory Advertising and Promotion to lead strategic regulatory efforts in compliance... ...FDA knowledge, significant experience in promotional submissions, and the ability to provide strategic advice on advertising materials...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Submissions Documentation Specialist. Be the first to apply!
Related searches
- regulatory compliance specialist Florham Park, NJ
- regulatory affairs consultant Florham Park, NJ
- regulatory affairs specialist Florham Park, NJ
- compliance coordinator Florham Park, NJ
- compliance specialist Florham Park, NJ
- healthcare compliance officer Florham Park, NJ
- coding compliance specialist Florham Park, NJ
- regulatory specialist Florham Park, NJ
- risk and compliance analyst Florham Park, NJ
- regulatory analyst Florham Park, NJ