Pharmas Market Jobs in United States

This remote role offers flexibility,solid pay,and proactive pharma foresight.Tracking global reg intelligence as a fractional analyst. · ...

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

· 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. · ...

+ Job summary: Oversee regulatory information management and operations as a fractional specialist, optimizing systems and processes. · + Qualifications: 7+ years in regulatory operations., expertise in RIM platforms., process optimization skills., database management experience. ...

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 ...

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

+Draft Module 3 CMC content. Support IND/NDA/BLA CMC strategies. Address agency CMC queries. · +Draft Module 3 CMC content. · Support IND/NDA/BLA CMC strategies. · ...

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

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

Manage regulatory teams and global filings as a fractional manager, driving lifecycle success. · ...

Author high-quality regulatory documents as a fractional medical writer. · ...

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

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

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

Lead advanced regulatory strategies and submissions as a fractional senior specialist for innovative therapies. · ...

Prepare and publish eCTD submissions as a fractional specialist ensuring timeline adherence. · ...

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. · ...

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. · ...

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

Support regulatory submissions and compliance as a fractional associate in dynamic pharma/biotech environments. · ...