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Regulatory strategy Remote Jobs

24 fresh jobs found

Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics
USA - Pennsylvania - North Wales (Upper Gwynedd)

CMC regulatory strategies Regulatory CMC Health authorities CMC regulatory strategy BLA IND Virology Technology development Scientific Excellence +50

Senior Full Time

USD 181K+

Regulatory Compliance Manager (Remote)
PW208: Connecticut Remote Remote Location , Remote City, CT, 06035 USA

NAA Regulations FAA Regulations QMS Regulatory issues Government Contracts Core Manufacturing operations Regulatory strategy Aviation +32

Senior Full Time

USD 96K+

Senior Manager, Regulatory Diagnostics
Remote (US)

ECTD CTD Regulatory Documentation Regulatory Guidance Protocols Regulatory strategy ICH Guidelines Regulatory knowledge Adobe Acrobat +31

Senior Full Time

USD 135K+

Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases
USA - Pennsylvania - North Wales (Upper Gwynedd)

Infectious Diseases Global Regulatory Affairs Clinical Safety Global Regulatory Strategy Independence Regulatory strategy Licensing Strategic direction Vaccines +29

Exec Senior Full Time

USD 164K+

Regulatory Affairs Director - Global Regulatory Leader (General Medicine/Cardiovascular)
US - California - Thousand Oaks - Field/Remote

Product Labeling Clinical trial applications Marketing Applications Regulatory expertise Global Regulatory Strategy Global regulations Life cycle management Regulatory Guidance Registration +32

Senior Full Time

USD 188K+

Director, Regulatory Affairs, Advertising/Promotion
Remote (US)

Commercial Compliance Promotional Materials Review Patient Safety Scientific Communications Healthcare Compliance Regulatory strategy Labeling Strategic Guidance Veeva Vault +36

Exec Senior Full Time

USD 166K+

Regulatory Affairs Director - Global Regulatory Lead
US - California - Thousand Oaks - Field/Remote

Data Sheet Development Clinical trial applications Product Labeling Marketing Applications Global Regulatory Strategy Regulatory expertise Obesity Global regulations Life cycle management +35

Senior Full Time

USD 188K+

Principal Scientist, Sterile Drug Product Commercialization
USA - Pennsylvania - West Point

In-process controls Drug Product Commercialization Facility fit Shelf-life strategies Packaging strategy Site characterization Multivariate analysis CMC regulatory strategy Manufacturing science +85

Senior Full Time

USD 164K+

Assoc. Dir., Biologics VCM Product Manager
USA - Pennsylvania - West Point

Large molecule operations Launch strategy Value Stream Mapping Large Molecule Commercial operations Regulatory strategy Manufacturing operations Commercial Strategy Change Control +73

USD 122K+

Director, Biologics VCM Product Leader
USA - Pennsylvania - West Point

Large molecule operations Cost projections Launch strategy Development and commercialization Value Stream Mapping Large Molecule Commercial operations Regulatory strategy Manufacturing operations +76

Senior Full Time

USD 164K+

U.S. Regulatory Affairs Senior Manager
US - California - Thousand Oaks - Field/Remote

Product Labeling Legislation Awareness Regulatory policy Global Regulatory Strategy Regulatory research Regulatory Documents Regulatory Guidance Regulatory strategy Labeling +26

Senior Full Time

USD 139K+

Regulatory Affairs Director - Oncology
US - California - Thousand Oaks - Field/Remote

Agency communication Clinical trial applications Global Regulatory Strategy Marketing Applications Regulatory expertise Life cycle management Global regulations Regulatory Guidance Regulatory strategy +26

Exec Senior Mid Full Time

USD 188K+

Senior Manager, Regulatory Affairs, CMC
Remote (US)

EU Regulatory Requirements Technical Document Authoring Microsoft 360 ICH Requirements US Regulatory Requirements Regulatory strategy Protocols CMC Financial excellence +23

Senior Full Time

USD 133K+

Executive Director, Global Regulatory Portfolio Lead
Remote (US)

Global regulatory environment People development Marketing Approval Health Authority Interactions Drug development process Regulatory Documentation Regulatory strategy Issue management Labeling +39

Senior Full Time

USD 212K+

Associate Principal Scientist, Sterile Drug Product Commercialization
USA - Pennsylvania - West Point

Scale-Up Processes Drug Product Commercialization Characterization Studies Life cycle management CMC regulatory strategy Performance qualification QbD principles Manufacturing science Process Performance +93

Senior Mid Full Time

USD 135K+

Director & Senior Counsel, Global Trade Investigations & Disclosures (Remote)
PW208: Connecticut Remote Remote Location , Remote City, CT, 06035 USA

Disclosures Regulatory strategy Global Trade Government Contracts Judgment Drafting Legal Compliance Investigations Contracts +22

Senior Full Time

USD 171K+

Regulatory Affairs Specialist
US Field Non-Sales (Remote Workforce)

Health software 21 CFR 801 Non-medical software 510k Medical software 21 CFR 820 EU MDR Medical device industry Product Lifecycle +16

USD 65K+

Executive Director, Device Quality & Regulatory
USA - New Jersey - Rahway

QMSR Regulatory Submission Quality oversight Regulatory CMC Health authorities Device technology IND BLA Device development +66

Exec Senior Full Time

USD 243K+

Associate Principal Scientist, Engineering
USA - Pennsylvania - West Point

Manufacturing Investigations Scale-down QbD Current good manufacturing practices Tech Transfer Regulatory Filing Process Characterization DOE Process Validation +83

Senior Mid Full Time

USD 135K+

Principal Scientist, Engineering
USA - Pennsylvania - West Point

Intravitreal product development Performance qualification Site characterization Manufacturing Investigations Packaging strategy Shelf-life strategies CMC regulatory strategy Multivariate analysis Tech Transfer +79

Senior Full Time

USD 164K+

Director, Global Regulatory Lead
Remote (US)

Global Regulatory Requirements Marketing Approval Health Authority Interactions Drug development process Regulatory Documentation Regulatory strategy Issue management Labeling Regulatory knowledge +39

Senior Full Time

USD 166K+

Associate Director, Pharmacometrics
Remote, REMOTE, United States

Pk/pd software Population pkpd analysis Pharmaceutics Pharmacometrics Monolix Nonmem Regulatory strategy Regulatory Guidance Clinical Pharmacology +10

Senior Mid Full Time

USD 144K+

Senior Manager Regulatory Strategy - Remote Opportunity
Deerfield, IL, US

Marketing Applications Cross-Functional Team Collaboration Regulatory strategy Documentation Management FDA regulations Clinical Studies Biologics Strategy Development FDA +10

Senior Full Time

USD 125K+

Senior Manager Regulatory Strategy - Remote Opportunity
Deerfield, Illinois, US

Marketing Applications Cross-Functional Team Collaboration Regulatory strategy Documentation Management FDA regulations Clinical Studies FDA Biologics Strategy Development +10

Senior Full Time

USD 125K+

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