CMC Documentation & Regulatory Submissions Manager
Bristol Myers Squibb
Bristol Myers Squibb is seeking a Manager for CMC Documentation & Specifications in New Brunswick, NJ. This role entails authoring CMC regulatory submissions, collaborating closely with various departments to ensure timely filings. The ideal candidate will have a degree in a relevant scientific field and at least 5 years of experience. Strong communication skills and attention to detail are critical for this position. Benefits include comprehensive health coverage, 401(k) options, and a flexible time off program. #J-18808-Ljbffr Bristol Myers Squibb
- Bristol-Myers Squibb is seeking a Manager for CMC Documentation in New Brunswick, NJ. The role involves compiling and authoring CMC sections of regulatory submissions, coordinating with various teams to ensure timely document delivery. Ideal candidates will have a degree...SuggestedFlexible hours
- ...for a contractor to support the Chemistry, Manufacturing, and Controls (CMC) documentation and specifications group. This role includes preparing and managing CMC content for regulatory submissions, collaborating with scientific teams, and ensuring high-quality documentation...SuggestedHourly payFor contractors
$204k - $244k
Scorpion Therapeutics is seeking a Director, Regulatory Affairs - CMC in Cranbury Township, New Jersey. This role involves developing and... ...therapy products, leading the preparation and review of submission documents, and interacting with health authorities. The ideal candidate...Suggested- Associate Principal Scientist, Regulatory CMC - Biologics (R4)... ...authorization process to prioritize submissions. Complete detailed global... ...and/or post-approval change documentation. Plan, track, and... ...Demonstrated leadership, project management, communication, interpersonal...Suggested
$204k - $244k
Director, Regulatory Affairs - CMC (Chemistry, Manufacturing, and Controls) Responsibilities Work... ...Lead the preparation/review of CMC submission documents, registration dossiers, and... ...functional Global Project Team, Change Management team, and governance meetings. Ensure...SuggestedTemporary work- ...looking for a detail-oriented Regulatory Affairs Associate to support regulatory... ...prepare and submit regulatory documentation, maintain compliance, and assist with FDA submissions to ensure adherence to... ...skills and project management abilities are essential. #J-1...
$165k - $220k
...the future. The Director, Regulatory Affairs leads global... ...with Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory... ..., ensure highquality submissions, and manage regulatory risk across the... ...strong attention to detail and document accuracy. Demonstrated ability...Temporary workWork visa- ...Malaysia is seeking an Executive Director for Regulatory Affairs based in Rahway, NJ. This role involves overseeing the regulatory CMC team and ensuring successful... ...The candidate will be responsible for managing CMC submissions, leading cross-functional teams, and influencing...
- ...Senior Director, Regulatory Affairs Date: May 23, 2... ...direction and providing management support for the US... ...reviewing ANDAs pre- or post-submission, proactively working... ...(all critical) of documents for submission to US regulatory... ...experience required (CMC and PK/PD Clinical...
- Regulatory Operations/Affairs Manager Onsite role New Brunswick, NJ Work Schedule: Mon -... ...provide relevant regulatory documentation (e.g. SOPs, Technical... ...transfer plans, and regulatory submission plans. Maintains strong... ...global personnel such as CMC. Participating in other...Contract workLocal areaWorldwide
- ...seeking an Associate Specialist of Regulatory Planning & Publishing for its Rahway... ...requires collaboration on regulatory submissions, ensuring high quality and timely deliveries... ...include planning, execution, and managing regulatory documents. The ideal candidate will need a...Work at officeFlexible hours
- A leading tech firm is seeking a Product Manager with extensive experience in regulatory submission processes and health authority queries. The role requires strong customer-facing skills and a deep understanding of pharma regulatory processes. Candidates with over 10...
$255.8k - $402.7k
## Executive Director, Regulatory AffairsApplyremote type: Hybridlocations... ...for Biologics (Biologics-CMC) is accountable for managing a team of CMC... ...of high quality CMC submissions for late phase new modality... ...review of major submission documents and response to Health Authority...For contractorsLocal areaRelocationVisa sponsorshipFlexible hours- ...Description Job Description Title: Regulatory Manager Location: Warren, NJ 07059 (... ...strategy to deliver timely approvals for US submissions and OTC Monograph product launches.... ...implement regulatory strategies and documents for new product launches and...Work at officeLocal areaDay shift
- ...discover new, on trend solutions. As a Regulatory Manager , you will oversee day-to-day... ...standard and moderately complex product documentation, including formulations, labels, and... ..., COO, Prop 65, flavor labeling, TTB submissions, and more). Support global market-...
$200k - $245k
...offices for an experienced Regulatory Affairs Director to support... ...responsibility for day‑to‑day NDA submission management and delivery. You will... ...‑cycle) including briefing documents, questions, response... ...Regulatory Lead across Clinical, CMC, Nonclinical, Biostatistics...Full timeWork at officeShift work$99k - $125k
...-to-day leadership and operational management of the Regulatory Affairs function. This role oversees... ...activities, including regulatory submissions, inspections and audits, recalls, licensing... ...promotional review, quality system documentation, risk management, and design...Temporary workWork experience placementMonday to FridayFlexible hours$16.82 - $31.25 per hour
## Document Compliance SpecialistApplylocations: DCH Brunswick Toyota, N. Brunswick, NJ 08902time type: Full timeposted on: Posted Yesterdayjob requisition id: R110579## Dealership:L0397 Driveway Home Office# **Driveway.com | Document Compliance Specialist**Driveway.com...Temporary workBank staffWork at officeHome officeShift work$142.4k - $224.1k
...Overview Associate Director, Regulatory Affairs supports... ...communications and submissions, including marketing applications... ...packages and documents associated with regulatory... ...and Control (CMC), and other functional... ...compliance and life cycle management) of oncology programs....For contractors- ...financial statement information provided for audit and tax reviews, documentation and set-up of the accounting principles for unusual... ...understanding of portfolio accounting, U.S. GAAP and the investment management industry- Excellent verbal and written communication skills-...Temporary workWork at office3 days per week
- ...Entity is seeking a Director, Technology Product Group Leader for Submission Excellence. This role involves overseeing the development,... ...engineering, and global operationalization of solutions to accelerate regulatory submissions. The ideal candidate will have extensive...
- Merck & Co. is seeking a Head of Regulatory Affairs in Plainsboro Township, NJ. This role involves defining and leading regulatory strategy for product submissions and approvals, and engaging with the U.S. FDA to ensure compliance. Candidates must have a doctorate or advanced...
- ...identifying and assessing regulatory and quality risks... ...inspection program. They will manage routine use of the... ...and oversee the Document Management System & Data... ...plans Contribute to CMC sections of regulatory... ...preparing regulatory submissions and response to health...Flexible hours
- ...Job Description Description: The Regulatory Affairs Associate, with minimal guidance... ...departments for obtaining documents for annual report submissions. Archive and maintain all post approval... ...functions as directed by Management to support projects and to ensure...
- Role: Regulatory Affairs Associate Location: United States Duration: Long Term... ...assist in preparing regulatory submissions, maintaining regulatory documentation, monitoring compliance... ...organizational skills. Ability to manage multiple projects and deadlines in...Long term contract
- ...Scientist for their Devices and Drug-Device Combinations Regulatory CMC team. This role involves supporting regulatory... ...products, ensuring adherence to global regulations and managing technical content for submissions. The ideal candidate will bring strong expertise in regulatory...
$137.6k - $180k
...Regulatory Affairs Advertising Promotion Specialist This position... ...Report(s): None Areas Managed: Advertising & Promotion North... ...preparing and submitting regulatory documentation to FDA Experience... ...with eCTD requirements and e-submission formats/processes of promotional...Temporary workNight shiftWeekend work- ...strengthening our U.S. -based quality management system and integrating... ...an experienced Senior Regulatory Affairs Quality Systems Manager... ...to lead FDA 510(k) and CLIA submissions and global quality system... ...quality systems. Manage document control, CAPA, training, and...Overseas
- ...program that supports ethical, legal, and regulatory practices across all operations at... ..., implementation, and ongoing management of the organization's compliance program... ...department leaders complete all required documentation, operational responsibilities, and regulatory...Flexible hours
$50k - $60k
...on their responsibilities/actions to be taken during accidents/incidents. Insure all incidents are properly documented, and communicated to management, insure remediation steps are taken to address future incidents; See and Be Seen - Spend at least 80% of the...Temporary workWork at officeLocal area
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