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Regulatory strategy Remote Jobs

26 fresh jobs found

Senior Principal Scientist, Regulatory Liaison (Sr. Director, GRL)
USA - New Jersey - Rahway

FDA Communication Global Regulatory Affairs Clinical Safety Global Regulatory Strategy IND Large Molecule Neuroscience Formulation Ophthalmology +34

Senior Full Time

USD 181K+

Senior Specialist, Regulatory Affairs - VIP/ADI (Remote)
NAPLES, FL, US, 34108

Engineering Change Requests Health Canada FDA Submissions Medical Device Regulations EU MDR Orthopedics Design control Risk Evaluation Labeling +9

Senior Full Time

USD 90K+

Senior Clinical Evaluation Specialist (Remote)
Massachusetts, Boston Virtual Address

Clinical evaluation Systematic Reviews Clinical Strategy New Product Development Medical Writing Regulatory strategy Clinical Documentation M Regulatory Affairs +24

Senior Mid Full Time

USD 75K+

Senior Director Nonclinical Development
United States Remote Office

Preclinical protocols Nonclinical development SOP comprehension Written presentation Analytical sciences Oral Presentation Toxicology GLP Pharmacology +29

Senior Full Time

USD 151K+

Associate Director, Global Regulatory Lead
Remote (US)

CTA Submission documentation Global regulatory environment Global Regulatory Requirements Marketing Approval Health Authority Interactions Drug development process Global Regulatory Strategy BLA +41

Senior Mid Full Time

USD 142K+

Director, Global Regulatory Strategist (Eye Care)
United States Remote Office

Health Authority Interaction Documentation preparation Global regulations Regulatory strategy Due Diligence Quality Standards Regulatory Affairs Drug Development Clinical Development +16

Exec Senior Full Time

USD 112K+

Associate Manager, Regulatory Operations
Remote (US)

Biopharmaceutical project management Regulatory project management ICH Requirements Regulatory operations Regulatory Documents Regulatory strategy Entrepreneurial Mindset MS Project Financial excellence +27

USD 95K+

Regulatory Affairs Senior Manager – Regional Regulatory Lead
US - California - Thousand Oaks - Field/Remote

Clinical trial authorization Marketing application approval Regulatory intelligence Regulatory policy Clinical trial authorizations Regulatory research FDA Interactions Regulatory Strategies Global Regulatory Strategy +28

Senior Mid Full Time

USD 139K+

Regulatory Affairs Senior Manager – Regional Regulatory Lead
US - Indiana - Indianapolis - Field/Remote

Clinical trial authorizations Regulatory intelligence Regulatory policy FDA Interactions Regulatory research Regulatory Strategies Marketing Applications Global Regulatory Strategy Regulatory Documents +25

Senior Mid Full Time

USD 139K+

Executive Director, Global Regulatory Affairs Companion Diagnostics
Remote (US)

Health Authority Engagement Global Regulatory Requirements People development Health Authority Interactions Regulatory Documents Regulatory strategy Entrepreneurial Mindset Regulatory Guidelines Financial excellence +36

Exec Senior Full Time

USD 212K+

Associate Director, Pharmacometrics
Remote, REMOTE, United States

Pk/pd software Population pkpd analysis Pharmaceutics Pharmacometrics Monolix Nonmem Clinical Pharmacology Pharmacokinetics Pharmacology +11

Senior Mid Full Time

USD 144K+

Manager, Regulatory Affairs (Clinical Submissions)
US-Nationwide-FIELD

Cardinal Health

Clinical Submissions Clinical Document Preparation Electronic Submission Systems Regulatory Software Regulatory Documentation Regulatory strategy Clinical Trial Design Pay equity Regulatory Submissions +17

Senior Full Time

USD 121K+

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

Continuous process optimization Antibody-drug conjugate In-process controls Facility fit Manufacturing science Analytical Technologies Drug Product Commercialization Shelf-life strategies Scale-down +100

Senior Full Time

USD 164K+

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

Sterile Products Antibody-drug conjugate In-process controls Drug Product Commercialization Facility fit Analytical Technologies Manufacturing science Shelf-life strategies Multivariate analysis +101

Senior Mid Full Time

USD 135K+

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 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+

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+

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+

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+

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+

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+

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+

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