Remote CMC Principal Consultant - Strategic Regulatory Lead
Opus Regulatory
Opus Regulatory, Inc. seeks Principal Consultants to join its CMC Practice, delivering strategic regulatory guidance and hands-on execution for development, registration, and commercialization. As embedded client team members, you will craft submission strategies, lead deliverables, and interface with client stakeholders and regulators. You will join a team that values solving complex regulatory challenges and driving client success across diverse product types and therapeutic areas. #J-18808-Ljbffr
$210k - $300k
...About Opus Regulatory: Founded in 1994, Opus... ...Regulatory (Opus) is a consultancy providing experts... ...Strategy, CMC, Labeling, and Advertising... .... Location: Remote | Levels:... ...We are hiring for Principal Consultant, Regulatory... ...). ~ Lead and facilities activities...Remote workPrincipalRegulatoryFull timeTemporary work$210k - $300k
...About Opus Regulatory: Founded in... ...is a specialist consultancy providing experts... ...Regulatory Strategy, CMC, Labeling, and... ...Openings | Remote | Associate Director... ...is hiring Principal Consultants to... ...you will combine strategic regulatory... ...submission strategies, lead regulatory...Remote workPrincipalRegulatoryTemporary work$230k - $300k
...About Opus Regulatory: Founded in 1994, Opus... ...) is a specialist consultancy providing experts... ...Regulatory Strategy, CMC, Labeling, and Ad... ...for several Principal Consultant, Regulatory... ...leadership. Provide strategic and operational... ...range. US-Remote Pay Range $230,0...Remote workPrincipalRegulatoryFull timeTemporary work$210k - $300k
...About Opus Regulatory: Founded in 199... ...is a specialist consultancy providing experts... ...Strategy, CMC, Labeling, and... ...Multiple Openings | Remote | Senior... ...Practice is hiring Principal Consultants to... ...you will combine strategic regulatory... ...teams, you will lead labeling initiatives...Remote workPrincipalRegulatoryFull timeTemporary workLocal area- ...Scorpion Therapeutics seeks a Lead for CMC formulation and manufacturing development to drive biopharma products toward rapid registration and regulatory submissions. You will provide strategic guidance, develop pediatric formulations, review external development and manufacturing...Remote workRegulatory
- ...23 by the world’s leading healthcare venture... ...talented and experienced Principal Scientist / Associate Director, CMC Formulation... ..., hybrid or fully remote). Key Duties... ...manufacturing, and regulatory submissions. · Partner... ...oversight, and strategic interpretation,...Remote workPrincipalRegulatoryFull time
- ...Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global biologics program. This... ...interactions. Local Boston candidates are preferred; remote East Coast candidates will also be considered. Occasional...Remote workRegulatoryLocal area
- ...Amylyx Pharmaceuticals is seeking an experienced Associate Director, CMC Program Management to provide strategic and operational leadership across the CMC portfolio. The role partners with Regulatory, Quality, Analytical Development, Supply Chain, External Manufacturing...Remote workRegulatory
- ...A management consulting firm is seeking a Principal Consultant Project Manager specializing in Utility Return... ...managing client engagements, advising on regulatory strategies, and overseeing project... ...days in Washington, DC, and two remotely, offering competitive salary and...Remote workPrincipalRegulatory
- ...Shionogi Inc. in Florham Park, NJ is seeking a Senior Manager, Regulatory Affairs CMC to lead strategic CMC regulatory activities under the guidance of the Senior Director. You will coordinate with R&D, QA, manufacturing, and commercial teams to align regulatory plans...Regulatory
$145 - $170 per hour
...find your next opportunity. Senior Regulatory CMC Lead Compensation: $145.00 - $170.00 Loading... ...CMC Lead Location: Boston, MA / Remote East Coast Shift : Monday-Friday,... ...Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global...Remote workRegulatoryHourly payFull timeTemporary workLocal areaMonday to FridayShift work- Scorpion Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic and operational leadership for global regulatory activities... ...commercialization of small molecule oral solid dosage forms. The role leads CMC submissions (INDs, NDAs), serves as primary liaison...Remote jobRegulatory
- ...Primary Responsibilities 1. Global Regulatory CMC Strategy Lead and drive the global Regulatory CMC... ...for biologic ADC programs. Provide strategic guidance for global MAA/BLA... ...Flexible for this to be Boston-office based, remote East-coast (USA) or hybrid....Remote workRegulatoryWork at officeFlexible hours
- DescriptionThe Principal Consultant specializing in Operational... ...risk management, and regulatory compliance. The Principal... ...to operate at both strategic and technical levels:... ...architectures, remote-access solutions, security... ...Consultant, you will lead strategic OT...Remote workPrincipalRegulatory
- ...Advisory teams combine strategic insight with... ...sustainability consultants and technical specialists... ...help the world’s leading organizations... ...for a Senior Principal Consultant to help... ...subcontractors, and regulatory agenciesexcellent... ...SummaryLocation: Remote, USA; Reno,...Remote workPrincipalRegulatoryPermanent employmentFull timeTemporary workFor subcontractor
- ...timePosted: 2026-10-12The principal consultant serves as a technical... ...and project lead for maritime client engagements... ..., safety, and regulatory compliance. Supports... ...Provide technical and strategic advice to shipowners,... ...While the position is remote, regular travel (50%+...Remote workPrincipalRegulatoryFlexible hours
- ...for driven, self-motivated Lead Consultants with a passion for empowering... ...processes across clinical, regulatory, quality, and drug safety with... ...developing and executing a strategic roadmap of enhancements for... ...strategic customers. This is a remote, full-time permanent role...Remote workRegulatoryPermanent employmentFull timeH1bWork at officeWork from home
- ...2026-10-12The Senior Principal Consultant serves as senior technical... ...Roles may include:Lead and manage complex consulting... ..., safety, and regulatory compliance.Provide technical and strategic advice to shipowners,... ...While the position is remote, regular travel (50%+)...Remote workPrincipalRegulatoryFlexible hours
$200k
...partner is looking for a Principal Consultant – Utility Prudence... ...clients on complex regulatory and financial matters... ...initiatives. You will lead consulting engagements... ...rate cases and strategic transactions. Working... ...development initiatives. This remote-first opportunity...Remote workPrincipalRegulatoryWork at officeFlexible hours- ...opportunitySWCA Environmental Consultants is seeking a Lead, Senior, or Principal Biologist with... ...worked in a hybrid or remote capacity from most locations... ...Project Leadership: Strategically consults on and leads complex... ...with industry and regulatory standards. Serves as a...Remote workPrincipalRegulatoryFull timeFor contractorsFor subcontractorWork at officeLocal area
$183k - $215k
...is seeking a Senior Principal Consultant, Water Resources to join... ...for helping lead and develop WestLand'... ...other senior leaders in strategic planning at both the... ...in Federal and Local regulatory water/wastewater standards... ...Flexible work schedules and remote/hybrid possibilities...Remote workPrincipalRegulatoryFull timeLocal areaFlexible hours- ...Talently is a fully remote recruitment agency built for high-performing full-desk... ...expertise and a proven ability to grow strategic client relationships. We provide the tools... ...your book of business. As a Principal/Team Lead Recruiter (Full-Desk), you’ll own searches...Remote workPrincipal
$177k - $242k
...for a Director, Gene Therapy CMC Lead on the Manufacturing, Science... ...serve as CMC Lead providing strategic and operational leadership for... ...through clinical development, regulatory submission, and... ...ll Work This is a fully remote role. It can be performed effectively...Remote workRegulatoryFull timeLocal areaFlexible hours- ...Inc. is seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across... .... This role focuses on regulatory compliance, inspection... ...risk-based assessments and strategic guidance. The position... ...involves conducting on-site and remote audits, preparing...Remote jobPrincipalRegulatory
- ...Veristat is seeking a Principal Medical Writer with CMC focus for remote work. You will lead authoring for complex regulatory submissions, mentor junior writers, and drive document quality across modules, including Module 3 and 2.3, ensuring alignment with global health...Remote workPrincipalRegulatory
$140.3k - $210.5k
...00 company and a leading AI platform for managing... ...Healthcare Consulting team is an... ...region. We are often remote from one another... ...Qualifications - Principal Consultant 7+ years... ...business consulting and strategic acumen, with a... ...landscapes, and regulatory environments to...Remote workPrincipalRegulatoryWork at officeHome officeFlexible hours$136k
...Science Job Level: Manager/Principal Business Unit:... ...governance, oversight, and strategic direction on risk and... ...and external/internal regulatory requirements. It... ...Principal Compliance & Risk Consultant on the Compliance... ...Functional Execution: Lead enterprise-wide initiatives...PrincipalRegulatoryWork experience placementWork at officeFlexible hours2 days per week3 days per week- ...Biotechnology seeks an independent CMC consultant to drive a first-of-its-kind... ...therapy program. You will lead CMC strategy, manage external... ...while drafting Module 3 for regulatory submissions. You’ll... ...plans and FDA-ready briefs. Remote with occasional travel, six-month...Remote workRegulatory
- ...Leading the authorship of regulatory documents, the full-time Principal Medical Writer - CMC will manage client engagements, mentor team members, and ensure high-quality documentation... ...for regulatory submissions in a fully remote environment. Key responsibilities Author...Remote workPrincipalRegulatoryFull time
- ...application process. Principal Architect - Practice Lead Full Time Level... ...design, and consulting firm. Consistently... ...while maintaining a strategic commitment to supporting... ...contractual and regulatory obligations. Partner... ...offices or remote teams Prior experience...Remote workPrincipalRegulatoryFull timeTemporary workLocal area
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