Pharmas Market Jobs in United States

+Manage regulatory compliance and audit readiness as a fractional manager Remote role strengthening systems and preparedness. · ++9+ years in regulatory complianceAudit experienceAdvanced degree management skillsRisk assessment expertise · ...

· This job is for a Combination Product Regulator who will oversee drug-device combination pathways as a fractional regulator, including 510(k)/PMA. The role is remote and has rewarding pay and hybrid product compliance. · ...

Author and manage CMC sections for regulatory submissions as a fractional specialist. · Draft CMC sections for submissionsEnsure quality and compliance in Module 3Support comparability and change assessmentsCoordinate with manufacturing teamsRespond to agency queries on CMC ...

Facilitate FDA Type A/B/C or EMA meetings as a fractional specialist. · ...

This remote role offers flexibility and leadership impact in immunology, oncology or rare disease studies. Provide strategic oversight for clinical trial planning execution and closeout as a fractional associate director. · ...

Lead FDA/EMA approvals for cell/gene therapies as a fractional regulatory lead. · ...

Job Summary Lead labeling updates and compliance as a fractional specialist. Remote role ensuring accurate global product labels. · ...

Advise on Pediatric Investigation/Study Plans as a fractional consultant ensuring EMA/FDA pediatric compliance. Competitive pay and focus on child health regulations. · ...

This remote role offers flexibility and competitive pay as a fractional clinical regulatory strategist for Phase I-III trials. · Create IND/CTA submission strategies. · Review clinical protocols for compliance. · ...

Job Summary · Provide strategic clinical development guidance across multiple autoimmune disease programs, with strong emphasis on Rheumatoid Arthritis and related conditions (including arthritis). This remote fractional role supports innovative bispecific antibody therapies from ...

· 8+ years in orphan designations. · Success with FDA/EMA expedited paths. · ...

++Develop REMS and EU RMP strategies as a fractional specialist for drug safety. · +Create REMS/RMP plans. · Manage periodic updates. · Ensure compliance monitoring. · ...

Advise on global harmonization and reliance pathways as a fractional specialist for streamlined approvals. Remote flexibility,paymnet premium international efficiency support. · ...

Manage regulatory publishing and operations as a fractional specialist, ensuring timely eCTD submissions. Remote role with focus on operational efficiency. · (Coordinate submission timelines) · ...

Drive revenue through targeted cold outbound to Series A/B biotechs with recent funding and urgent hiring needs. · Identify high-intent targets using funding data (Crunchbase), milestone announcements, and industry news sources. · ...

Manage day-to-day execution of clinical trials as a fractional CTM ensuring timelines budget and quality standards are met Remote role focused on effective trial delivery. · ...