Senior Manager, CMC Regulatory Affairs (Remote)
Travere Therapeutics
- Remote job
Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs in San Diego to provide strategic regulatory leadership for CMC activities across development and commercial programs. The role emphasizes oral solid dosage forms and cross-functional collaboration with development, manufacturing, QA, and regulatory teams. The ideal candidate will have 7+ years in regulatory affairs for small molecule products, including IND through NDA experience, and strong expertise in CMC documentation #J-18808-Ljbffr Travere Therapeutics
- ...what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience... ...functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on... ...flexible working arrangements, remote work options, and tax assistance...Remote workSeniorHourly payWork at officeLocal areaRelocation packageFlexible hours
$132k - $172k
...science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational... .../or onsite in San Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere provides comprehensive...Remote workSeniorFull timeTemporary work$132k - $172k
...science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational... .../or onsite in San Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere provides comprehensive...Remote workSeniorFull timeTemporary workWorldwide- Brief Description: The Senior Manager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support for commercial... ...language - written and verbal communication skills. #LI-SM1 #LI-remote #J-18808-Ljbffr Jazz PharmaceuticalsRemote workSeniorWorldwide
- Job Description NewAmsterdam Pharma (NAP) is seeking a Senior Manager CMC Regulatory Affairs who will support the development and execution of global... ...compliance with global regulatory requirements. This is a remote position with team building and conference travel...Remote workSeniorLocal area
- ...equal opportunity employer and will consider all qualified applicants for employment. Position: Senior Manager | Associate Director, Regulatory Affairs (CMC) Location: Remote Job Id: 359 # of Openings: 1 Senior Manager | Associate Director, Regulatory Affairs (CMC)...Remote workSeniorWork at officeShift work
- ...and happier lives. Job Summary The , CMC Global Regulatory Affairs is responsible for leading all... ...Global Regulatory Affairs and may be remote or based at Liquidia in Research Triangle... ...knowledge of drug development and life cycle management concepts and interdependencies with...Remote workSeniorContract workShift work
$175k - $205k
Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco, CA or remote Erascais a clinical-stage precision oncology company focused on discovering, developing... ...Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC...Remote workSeniorTemporary workCasual workLocal areaWorldwideFlexible hours- ..., X and YouTube. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to... ...hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & Lake County, IL...Remote workSeniorFull timeWork at officeLocal area
$134.2k - $202.2k
...MassachusettsShift: Department: HC-RD-RCD1 Reg CMC LM Marketed 1Recruiter: Sarah... ...outside of the organization.Your Role:The Senior Manager Regulatory CMC (RCMC) is responsible and... ...worldwide, and serves as the Regulatory Affairs CMC contact point and acts as the liaison...SeniorLocal areaImmediate startWorldwide$155.75k - $213.6k
Job Description:Job PurposeThe Senior Manager of CMC Regulatory Affairs will be responsible for creating CMC regulatory development plans and for successful execution against those plans. The Senior Manager of CMC Regulatory Affairs represents the function on departmental...SeniorFull timeTemporary workWork at officeLocal areaNight shiftWeekend workAfternoon shift3 days per week- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The role involves preparing CMC documents, ensuring regulatory compliance, and coordinating global submissions. The ideal candidate...Remote jobSenior
- ...rational combination programs. As Senior Manager, Regulatory Affairs , you will play a key role in... ...Biometrics , Medical Writing , Safety , CMC , Nonclinical , and Quality .... ...professional development opportunities. Remote working environment with frequent in-...Remote workSeniorFull time
- Location: North Carolina/Remote Organizational Overview TG Therapeutics is a fully integrated... ...Associate Director/Director/Sr. Director, Regulatory CMC reports to the Vice President of Regulatory CMC and is responsible for managing the Company’s Regulatory CMC function to...Remote workSeniorFull timeContract workVisa sponsorshipWork visa
- ...on LinkedIn. Position Summary: The Senior Manager, Regulatory Affairs will support the development and execution... ...across nonclinical, clinical, CMC, and device components for Avalyn's development... ...match Enjoy flexible schedules and remote work options that support a healthy...Remote workSeniorTemporary workLocal areaFlexible hours
$188k - $215k
...quality of work. What You’ll Do Senior Manager / Associate Director, CMC Regulatory Sciences reports to the head of CMC... ...Development) and Regulatory Affairs to design and implement control strategies... ...2‑3x per week. A US‑based fully remote role may be considered for the...Remote workSeniorFull timeWork at officeLocal areaFlexible hours- ...implement comprehensive regulatory strategies for new... ...development, productlife cycle management, and post-market... ...junior regulatory affairs professionals, fostering... ...years in a leadership or senior role.Demonstrated... ...and work-life balance. Remote or field-based positions...Remote workSeniorFull timeWork at office
- ...Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission...Remote workSeniorFull time
$240k - $275k
...Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will provide strategic... ...including Clinical, CMC, Biometrics, and Translational... ...authority.Experience managing regulatory risk and... ...in San Diego office. Remote permitted upon...Remote workSeniorFull timeSummer workWork at officeRelocationRelocation packageShift work$280k - $310k
...get it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will... ...topics, and effectively oversees change controlsBuilds and manages relationships through active partnering with key internal...SeniorLocal area$195k - $330k
...development and execution of global regulatory CMC strategies for degrader... ...regulatory CMC guidance to senior leadership regarding health... ...and lead the Regulatory Affairs CMC function as the pipeline... ...control strategy, and lifecycle management.Demonstrated success...Senior- ...Therapeutics in San Diego, CA is seeking an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics across... ...late-stage development, Phase 3 programs, and lifecycle management, with responsibility for submissions (INDs, BLAs/NDAs, MAAs...Remote jobSenior
$169.5k - $248.6k
...health is understood and managed, and support the... ...the RoleAs the Global Regulatory Lead (GRL), you will be... ...regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E,... ...experience in regulatory affairs and/or drug developmentORBachelor... ...is provided, remote is not available for this...Remote workSeniorLocal areaRelocationFlexible hours$250k - $300k
Menlo Park, CARegulatory Affairs - Regulatory Affairs /Regular, Full... ...Position Summary: The Senior Director, Regulatory... ...and lifecycle management, while also maintaining... ...indications, global expansion, CMC Regulatory and other... ...permitted by law. For remote-based positions, this...Remote workSeniorFull timeLocal areaImmediate start$157.59k - $203.94k
...empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and Device is responsible for supporting CMC regulatory activities for development or...SeniorFull timeFor contractorsLocal area- Travere Therapeutics seeks an experienced Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for CMC activities across development and commercial programs. You will lead global submissions for biologics, interact with Health Authorities...Remote jobSenior
- AbbVie seeks a Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology to lead regulatory activities and supervise professionals.... ...promo, with a hybrid work schedule (3 days in office, 2 remote) at one of AbbVie’s headquarters, including Florham Park,...Remote workSeniorWork at office
$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...project team colleagues, line management, and key stakeholders are apprised... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda...Remote workMinimum wageTemporary workLocal areaWorldwide$148.5k - $257.4k
...need them, improve the understanding and management of disease, and give back to our... ...provides strategic, tactical and operational regulatory CMC leadership across therapeutic... ...InformationPosition Location: Indianapolis, IN. A remote option may be considered. Relocation...Remote workRelocation packageFlexible hours$165k - $185k
.... Join us on our journey of growth! Remote/Commuter Opportunity - Open to candidates... ...the United States SUMMARY: The Senior Manager, Regulatory Strategy (US RA): supports the... ...regulatory perspective at Regulatory Affairs Focus Team (RAFT) meetings. Identifies...Remote workSeniorWork at officeFlexible hours
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