Senior Regulatory Scientist, CMC & Submissions | Remote
$94.9k - $135.6kCardinal Health
- Remote job
Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy for pre-approval and post-approval activities. The role demands proficiency in regulatory documentation and independent management of multiple tasks. Responsibilities include authoring high-quality submissions and mentoring junior staff. This position offers a remote working option and requires in-depth knowledge of CMC regulatory affairs and compliance standards. Enjoy a salary range of $94,900 - $135,600 along with extensive benefits. #J-18808-Ljbffr Cardinal Health
- Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy for client Rx and non-Rx programs. This senior-level role requires the... ...strategic input on complex submissions. The successful candidate... ...stakeholders. This position is remote and offers a competitive...Remote jobSeniorRegulatory
- Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for pre- and... ...documents, guiding complex submissions, and coordinating with cross-functional... ...to ensure global compliance. Remote work is available; senior staff mentor junior team...Remote jobSeniorRegulatory
- Cardinal Health is seeking a Scientist III CMC to lead the regulatory strategy for client programs. This senior role offers the opportunity to shape regulatory submissions while mentoring junior staff. The... ...works independently in a remote capacity, ensuring high-quality...Remote jobSeniorRegulatory
- Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for product lifecycle management. This senior-level role requires independent work and effective... ...regulatory knowledge. The position is remote, offering flexibility in a dynamic work...Remote jobSeniorRegulatory
- Cardinal Health is seeking a Scientist III CMC in Dublin, Ohio, who will lead regulatory strategy and execution for client projects in a remote setting. The ideal candidate will have experience in pharmaceutical product development and must possess a MS/BS in Chemistry...Remote jobSeniorRegulatory
- ...Control to lead analytical method validation for cell therapy products. This role requires expertise in authoring CMC quality sections for regulatory submissions and ensuring compliance with GMP standards. The ideal candidate will have extensive experience in cell therapy,...SeniorRegulatory
$135.95k - $164.74k
...Senior Principal Scientist, Analytical Chemistry Working with Us Challenging... ...analytical and CMC strategies that... ...guidelines and global regulatory requirements and has... ...support regulatory submissions. Respond to regulatory... .... Field‑based and remote‑by‑design roles require...Remote workSeniorRegulatoryHourly payFull timeTemporary workSummer workFlexible hoursShift work- Travere Therapeutics is seeking a Senior Manager for CMC Regulatory Affairs to lead the development and execution of global regulatory strategies.... ...commercialization. Your role will involve driving regulatory submissions, managing Health Authority interactions, and ensuring...Remote jobSeniorRegulatory
$120.8k - $181.2k
...General Summary: The MSAT Senior Scientist (Investigations and Strategic... ..., Process Development and Regulatory teams to ensure robust... ...Experience authoring/reviewing CMC product submissions and post-approval changes.... ...Status: Hybrid (remote up to two days per week) or...Remote workSeniorRegulatorySummer workFlexible hours2 days per week3 days per week- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to lead regulatory strategies and submissions for biologic products. The role demands extensive experience in regulatory affairs, especially for biologics, focusing on late-stage development. Located...Remote jobSeniorRegulatory
- Role, Inc. is seeking a Senior Manager for CMC Regulatory Affairs in San Diego, focusing on global regulatory strategies... ...-stage development programs and regulatory submissions. The position is hybrid, allowing for both remote and on-site collaboration, and offers a competitive...Remote jobSeniorRegulatory
- Travere Therapeutics is seeking a Senior Manager for CMC Regulatory Affairs. This role involves leading regulatory... ...for biologic products and managing submissions for clinical development and... ...Kansas City but offers flexibility for remote work. #J-18808-Ljbffr Travere...Remote jobSeniorRegulatory
- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for Chemistry, Manufacturing... .... The role requires managing global regulatory submissions and team collaborations, necessitating extensive experience...Remote jobSeniorRegulatory
- Travere Therapeutics is looking for a Senior Manager in CMC Regulatory Affairs to provide strategic... ...CMC regulatory strategies, managing submissions, and working closely with cross-functional... ...work environment while being largely remote. #J-18808-Ljbffr Travere...Remote jobSeniorRegulatory
- Travere Therapeutics is looking for a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for Chemistry, Manufacturing... ...strategies for biologic products and work on regulatory submissions, ensuring alignment with global requirements. The ideal...Remote jobSeniorRegulatoryWorldwide
- ...within the Targeted LNP (tLNP) CMC Development Team at AbbVie is... ...building a strong team of scientists who will be instrumental in developing... ...Quality Assurance and CMC‑Regulatory Affairs. Responsibilities... ...Author and review regulatory submission documents, such as IND and...SeniorRegulatoryTemporary workLocal area
- BioSpace is seeking a Senior Manager in Regulatory Affairs to lead the CMC strategy for biologic products. Key responsibilities... ...include preparing regulatory submissions, analyzing regulatory changes,... ...with 3 days in office and 2 days remote at our North Chicago, IL...Remote workSeniorRegulatoryWork at office
$94.9k - $135.6k
Location Remote Responsibilities Develop regulatory strategy and execution plan for pre‑approval, post‑approval changes... ...structure, content strategy, and submission approach for complex regulatory... ...rigor. Provide strategic input on CMC and lifecycle change assessments, including...Remote workRegulatoryTemporary workLocal areaWork from homeHome officeFlexible hours- ...Senior Clinical Scientist – Late Phase Development (Phase III / Registration) We are partnering... ...Scientist to support pivotal trials and regulatory submissions. This individual will play a key... ...hybrid in Central California, with remote flexibility for the right candidate...Remote workSeniorRegulatory
$31.5 - $40.41 per hour
## Scientist I - CMCApplylocations: US-Nationwide-FIELDtime... ...opening for a Scientist I - CMC**What Chemistry,... ...Scientist I - CMC supports regulatory activities for pre-approval... ...high-quality regulatory submission content.**Location**Remote**Responsibilities*** Support...Remote workRegulatoryHourly payTemporary workFor contractorsWork experience placementWork at officeImmediate startFlexible hours- UCB is seeking a Regulatory CMC Scientist to join the Global Regulatory team in Raleigh, North Carolina, or other offices. The role entails defining strategy and preparing CMC submissions for regulatory approvals, working closely with technical and regulatory teams. Qualified...Regulatory
- UCB is looking for a Regulatory CMC Scientist to join our Global Regulatory team. This role, based in Atlanta, GA, involves defining submission strategies and leading CMC regulatory submissions. The candidate should have a robust background in the pharmaceutical industry...Regulatory
- UCB Inc. is seeking a Regulatory CMC Scientist to join our Global Regulatory team based in Atlanta. The role involves defining strategies for CMC submissions and ensuring timely approvals with a focus on collaboration across various teams. A Bachelor's degree is required...Regulatory
- Fosun Pharma USA Inc. is seeking a Regulatory Affairs CMC leader to steer global CMC regulatory strategies for development and commercial products. This role oversees preparation, review, and submission of high-quality CMC dossiers and ensures compliance with global regulatory...SeniorRegulatory
- ...Palo Alto, CA, seeks an Associate Director for Regulatory Affairs, focusing on Chemistry, Manufacturing, and Controls (CMC) to coordinate global regulatory filings. The... ...preparation and management of regulatory submissions. Applicants with a Bachelor's degree in Chemistry...SeniorRegulatory
- Talent Groups is seeking a Senior Scientist to lead bioanalytical assay development for DMPK and immunogenicity in oligonucleotide... ...support, and collaboration with cross-functional teams to advance candidates toward regulatory submission. #J-18808-Ljbffr Talent GroupsRemote jobSeniorRegulatory
$94.9k - $135.6k
...Distributors Association is looking for a skilled regulatory professional to develop strategies and... ...compliance documentation. This remote role emphasizes collaboration with teams... ...mentoring junior staff to ensure accurate submissions. Candidates should have advanced...Remote jobSeniorRegulatory$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading regulatory... ...strategies for drug approvals and submissions. Candidates should have extensive experience... .... The position is hybrid, with remote work and occasional onsite requirements...Remote jobRegulatory- ...Allergan Aesthetics portfolio. Senior Manager, Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) The Senior Manager works... ...strategy for regulatory submissions (INDs/CTAs, amendments, new... ...(3 days in office & 2 days remote) at the Waltham, MA & Lake County...Remote workSeniorRegulatoryWork at office
- Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners... ...strategy for regulatory submissions (INDs/CTAs, amendments, new... ...(3 days in office & 2 days remote) from the Waltham, MA & Lake...Remote workSeniorRegulatoryWork at office
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