Senior Regulatory Submissions Specialist - eCTD & FDA
Breckenridge Pharmaceutical
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 with cross-functional teams to align on FDA/ICH requirements and SOPs. The role offers a competitive package with flexible work options and comprehensive health benefits. #J-18808-Ljbffr Breckenridge Pharmaceutical
$115k - $135k
...the world. Responsibilities Publishes US Regulatory Submissions to the Food and Drug Administration:... ...PADERS, etc. on time in accordance with eCTD submission requirements. Works with the... ...templates that are fully compliant with FDA and ICH document requirements....SeniorWork at officeFlexible hours- ...The Regulatory Affairs Sr. Associate is an experienced medical device regulatory professional... ...strategy input, prepares and maintains submission and technical documentation content,... ...and support submission packages such as FDA 510(k) files, EU/UK Technical Documentation...SeniorWork at office
- Scorpion Therapeutics seeks a Specialist II for Regulatory Documentation to ensure that regulatory submissions meet Health Authority requirements. The successful candidate will manage and publish documents while maintaining compliance and organization. Applicants should...SuggestedMonday to Friday
- Scorpion Therapeutics in Summit, NJ is seeking a Specialist III, Regulatory Documentation. This role involves managing and publishing documents to... ...comply with Health Authority requirements and coordinating eCTD modules. The ideal candidate will have a Bachelor's in life...Suggested
- ...solutions provider in New Jersey is seeking a Regulatory Affairs Associate to prepare and submit annual reports to the FDA. The ideal candidate will have a Master’s... ...industry. Key responsibilities include coordinating submissions and maintaining regulatory databases. Strong...Suggested
- Position Summary The Specialist II, Regulatory Documentation reports to the Director, Regulatory Documentation... ...of Electronic Common Tech Document (eCTD) modules. Essential Functions Create... ...(reports, assessments, regulatory submissions, letters, etc.) Format and compile...
- Position Summary Specialist III, Regulatory Documentation will provide expertise in the management and... ...of Electronic Common Tech Document (eCTD) modules. Essential Functions Create... ...internal departments on preparation and submission of regulatory documentation Generate...Temporary work
$40 - $57 per hour
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...Hourly pay$88k - $125k
...world. About the Role The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-... ...supplements in compliance with FDA requirements. Author relevant eCTD sections using company templates and...SeniorFlexible hours- Position Summary The Senior Scientist, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control... ...products and manage preparation of dossiers in eCTD format. This role supports submission strategies for CMC modules and updates, including...Senior
- 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...Senior
- Stark Pharma is looking for a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices and... ...regulatory documentation, maintain compliance, and assist with FDA submissions to ensure adherence to regulatory standards. The ideal...
- ...Talent. Job Description Description: The Regulatory Affairs Associate, with minimal guidance... ...high quality annual reports with FDA within Annual report timelines and in accordance... ...obtaining documents for annual report submissions. Archive and maintain all post approval...
$28.36 per hour
...role will ensure Berje’s compliance with all Regulatory Standards globally. You will support the preparation, organization, and submission of regulatory documentation related to the... ...products. You will work closely with senior team members and customers to ensure that...Local area$45k - $83.5k
...location NJE Non Clinical CBO New Providence, NJ 07974, USA Description The Credentialing Specialist reports to the Credentialing Manager and is responsible for timely submission and follow-up of payer enrollment applications and credentialing applications for appointment...Full timeShift work- ...for communication between the FDA and manufacturing sites.... ...and DMF for the U.S. FDA in eCTD format. Preparation, Review... ...activities which include, timely submission of Annual Reports, CPP,... ...new product launch Manage regulatory correspondence mainly to CDER...SeniorLocal area
$77k - $202k
...A global consulting firm is seeking a Senior Associate for SAP Security in Florham Park, NJ. This role focuses on designing and assessing security measures for SAP Global Trade Services solutions. The ideal candidate should have at least 3 years of experience in SAP auditing...SeniorFull time- ...leading 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...Senior
$33.33 - $58.67 per hour
Direct Jobs is looking for a credentialing specialist in Morristown, NJ, responsible for developing clinician delineation of privileges forms and ensuring compliance with accreditation standards. Candidates must have a minimum of 3-5 years in Medical Staff Services and...SeniorHourly payFull time$77k - $202k
PwC is seeking a SAP Business Process & IT Controls Sr Associate in Florham Park, New Jersey. In this full-time role, you will optimize operational efficiency through business consulting, focusing on SAP compliance and security. You will engage with clients, analyze complex...SeniorFull time$50 - $60 per hour
DataAnnotation is committed to creating high-quality AI. Enjoy the flexibility of remote work and the freedom to set your own schedule. This is an opportunity to work with us as an independent contractor. We're currently expanding into an exciting new area – teaching...SeniorHourly payContract workFor contractorsWork experience placementRemote work$120k - $145k
...Senior Account Executive Join HUB International! We're a thriving community of entrepreneurs driven by purpose and passion. Every... .... Prepare detailed coverage analysis for new business submissions and any renewal marketing submissions. Receive, review, and...SeniorWork experience placementLocal area$190k - $200k
...full-time Associate Director, Regulatory Affairs to effectively develop regulatory strategies and submission plans. This position would be... ...with regulatory authorities (FDA and/or global), providing... ...changes to project teams and senior management and recommend strategies...Full timeTemporary workWork at officeLocal areaRemote workFlexible hours$46.7 per hour
...Stewardship reports. Maintain renewal expirations, avoid any lapse in coverage. Responsible for marketing process. Preparation of submissions to carriers, including application preparation, loss analysis and including other pertinent information for professional, quality...SeniorWork at officeLocal area- A leading technology firm in New Jersey seeks a qualified candidate for a senior position in Systems and Information Security. This role requires 8-12 years of experience and significant expertise in managing Okta and Identity and Access Management (IAM) solutions. The...Senior
- Rutgers University Behavioral Health Care (UBHC) seeks a Mental Health Specialist III in Addiction Services. The role supports a safe therapeutic milieu, assists staff nurses, transports clients, and participates in group activities and crisis intervention. Requirements...Senior
- Westfield Insurance in Berkeley Heights, NJ, seeks a Senior Underwriter, Reinsurance, to underwrite Stop‑Loss, Excess Reinsurance and other specialty products. You will work with brokers to price and design quotes and manage assigned MGA/MGU relationships. Reporting to...Senior
$128k - $216k
...on a global scale, come make a difference at Fiserv. Job Title Senior AI Solutions Engineer About the role As a Senior AI Solutions... ...information. Note to agencies: Fiserv does not accept resume submissions from agencies outside of existing agreements. Please do not send...SeniorWork at officeVisa sponsorshipMonday to Friday- ...A technology consulting firm is seeking a Senior Mainframe Engineer to work on mainframe modernization projects. This role demands over 8 years of experience with COBOL, CICS, JCL, DB2, VSAM, and IMS. Responsibilities include developing code, performing data migrations...Senior
$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...Hourly pay
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