Jobs in USA

About 31408 results in (2) seconds Clear Filters

Jobs Search

About 31408 results in (2) seconds
Director, Regulatory Labeling at Regeneron Pharmaceuticals
Remote, Oregon, USA - Full Time
Skills Needed
Good Communication Skills
Specialization
Life sciences
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Physical Therapist at Concentra
Commerce, CA 90040, USA - Full Time
Skills Needed
Training, Hipaa, State Laws, Customer Service Skills, Writing, Computer Skills, Time Management
Qualification
Graduate
Medical Assistant Instructor at Rockford Career College
Rockford, IL 61108, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Java/C++ Software Engineer at Leidos
Washington State, Washington, USA - Full Time
Skills Needed
Protocol Buffers, Languages, C++, Product Delivery, Software Design Patterns, Engineers, Cameo, Ros, Confluence, Java, Bitbucket, Eligibility, Integration, Python, Scons, Rust, Vmware, Docker, Software Development, Jira
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Sr .Net SQL Developer at sonataOne
Dallas, Texas, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Visiting Assistant Professor of Law at Albany Law School
Albany, NY 12208, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 6 year(s)
Survey Technician / LSIT at Parkhill
Lubbock, TX 79423, USA - Full Time
Skills Needed
Deeds, Construction, Legal Descriptions
Specialization
Qualified to degree level or equivalent
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Senior Director, HR Transformation Transaction Services | Corporate Finance at FTI Consulting Inc
Chicago, Illinois, USA - Full Time
Skills Needed
Finance, Workforce Analytics, Performance Improvement, Organizational Design, Hr Consulting, Hr Operations, Carve Outs, Due Diligence, Powerpoint, Business Strategy, Excel
Specialization
Accounting, HR
Qualification
Graduate
Experience Required
Minimum 7 year(s)
Payroll/HR Coordinator at marktalkoncorpcom
Brighton, MI 48114, USA - Full Time
Skills Needed
Discretion, Interpersonal Skills, Confidentiality
Specialization
Human resources accounting business or related field
Qualification
Trade Certificate
Bellstand Attendant at Marriott International Inc
San Francisco, CA 94108, USA - Full Time
Skills Needed
Access, Flexible Spending Accounts, Life Insurance, It
Qualification
Diploma
News Production Assistant at Audacy Inc
Los Angeles, CA 90036, USA - Full Time
Skills Needed
Office Equipment, Facebook, Presentations, Sports Radio, Instagram, X, Communications, Materials, Linkedin
Qualification
Graduate
Assistant Controller at Eastern Idaho Regional Medical Center
Idaho Falls, ID 83404, USA - Full Time
Skills Needed
Financial Statements, Close Process, Color, Travel, Relocation, Budget Preparation, Financial Analysis, Completion, Mental Health Care, Dignity, Journal Entries, Compassion, Common Sense
Specialization
CPA
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Senior Social Media Specialist at Pegasystems
Waltham, MA 02451, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 3 year(s)
AVP, Business Design & Solutioning – Client Solutioning at LPL Financial
Fort Mill, SC 29715, USA - Full Time
Skills Needed
Management Consulting, Financial Services, Product Management
Qualification
Graduate
RN Neuro Telemetry at Bakersfield Memorial Hospital
Bakersfield, CA 93301, USA - Full Time
Skills Needed
Addition, Wound Care, Computer Skills
Qualification
Graduate
Principal Product Manager - Artificial Intelligence at Splunk
California, California, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Senior Vice President Sales, Field Service Management at IFS
Itasca, Illinois, USA - Full Time
Skills Needed
Management Skills, Teams, Go, C Level, Manufacturing, Business Software, Complex Sales, Channel Partners
Specialization
Sales/Marketing
Qualification
MBA
North Lauderdale - Speech Language Pathologist/Speech Therapist - Therapy i at Sobe Innovative Rehab
North Lauderdale, FL 33068, USA - Full Time
Skills Needed
Speech Therapy, Physical Therapy, Occupational Therapy
Specialization
Speech therapy
Qualification
Graduate
Rheumatology APP in Thriving Tucson AZ at Banner Health
Tucson, Arizona, USA - Full Time
Skills Needed
Security, Communication Skills, Dea, Surf, Patient Care
Qualification
Graduate
Principal Software Systems Engineer at Baxter
Raleigh, North Carolina, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Director, Regulatory Labeling at Regeneron Pharmaceuticals
Remote, Oregon, USA -
Full Time


Start Date

Immediate

Expiry Date

17 Sep, 25

Salary

336600.0

Posted On

17 Jun, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

The Director, Regulatory Labeling manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC and Rest of World (RoW) labeling. Provides labeling expertise to the Labeling Working Group and other relevant stakeholders, carrying out responsibilities independently. Leads development of labeling strategies and is responsible for the management of marketed or pipeline products, across the product lifecycle. Responsible for coordination of labeling strategies across program-specific deliverables and junior labeling team members.

Responsibilities

IN THIS ROLE, A TYPICAL DAY MIGHT INCLUDE:

  • Managing the Regulatory labeling process throughout the product lifecycle.
  • Leading the Labeling Working Group and manages development, review, approval, and maintenance of labeling for CCDS, USPI, EU SmPC, and RoW labeling.
  • Managing programs of highest complexity independently. Responsible for oversight and coordination of labeling strategies across program-specific deliverables and junior labeling team members.
  • Leading development of labeling strategies through interpretation of labeling regulations, guidelines and competitor analyses, and application to product situation.
  • Leading development of target labeling documents to support the design and analysis plan for clinical trials.
  • Leading discussions on labeling topics at relevant management interactions.
  • Effectively communicates labeling rationales to various levels of management to enable decision making.
  • Providing labeling expertise on complex issues to stakeholders. Anticipates Health Authority (HA) perspectives and broader implications of strategies, proposing alternatives and providing advice to mitigate risk. Communicates consequences to product portfolio.
  • Preparing submission-ready labeling documents. Maintains labeling documents in the electronic document management system and relevant labeling trackers as appropriate.
  • Contributing to the development of the Regulatory Labeling Group through active knowledge sharing and mentoring of junior staff members to build labeling expertise.
  • Monitoring worldwide regulation changes pertaining to Labeling regulations and maintains the labeling SOP and work instructions.
  • Responsible for leading or contributing to various continuous improvement projects.
  • Representing the labeling team on external industry groups.

THIS ROLE MIGHT BE FOR YOU IF CAN/HAVE THE:

  • In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and the drug development process. Familiar with policies and operating procedures in medical safety regulatory and/or corporate and worldwide Regulatory Agencies.
  • Ability to think strategically, assess risks and propose strategies to manage risk.
  • Ability to lead Labeling Working Groups to address labeling issues, develop plans of action, and oversee completion of complex labeling projects.
  • Expert knowledge of FDA, EMA, and international labeling regulations, ICH guidelines, and CIOMS core labeling guidelines.
  • Ability to assimilate clinical and scientific information and present it in a concise manner.
  • Ability to work independently and use judgment to make decisions and escalate problems appropriately. Proactively share information with peers and generate discussion to resolve complex issues.
  • Ability to handle multiple projects and prioritize work independently.
  • Ability to operate in ambiguous situations and provide functional guidance to others.
  • Attention to detail and strong word processing skill.
Director, Regulatory Labeling at Regeneron Pharmaceuticals
Remote, Oregon, USA - Full Time
Skills Needed
Good Communication Skills
Specialization
Life sciences
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Physical Therapist at Concentra
Commerce, CA 90040, USA - Full Time
Skills Needed
Training, Hipaa, State Laws, Customer Service Skills, Writing, Computer Skills, Time Management
Qualification
Graduate
Medical Assistant Instructor at Rockford Career College
Rockford, IL 61108, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Java/C++ Software Engineer at Leidos
Washington State, Washington, USA - Full Time
Skills Needed
Protocol Buffers, Languages, C++, Product Delivery, Software Design Patterns, Engineers, Cameo, Ros, Confluence, Java, Bitbucket, Eligibility, Integration, Python, Scons, Rust, Vmware, Docker, Software Development, Jira
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Sr .Net SQL Developer at sonataOne
Dallas, Texas, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Visiting Assistant Professor of Law at Albany Law School
Albany, NY 12208, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 6 year(s)
Survey Technician / LSIT at Parkhill
Lubbock, TX 79423, USA - Full Time
Skills Needed
Deeds, Construction, Legal Descriptions
Specialization
Qualified to degree level or equivalent
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Senior Director, HR Transformation Transaction Services | Corporate Finance at FTI Consulting Inc
Chicago, Illinois, USA - Full Time
Skills Needed
Finance, Workforce Analytics, Performance Improvement, Organizational Design, Hr Consulting, Hr Operations, Carve Outs, Due Diligence, Powerpoint, Business Strategy, Excel
Specialization
Accounting, HR
Qualification
Graduate
Experience Required
Minimum 7 year(s)
Payroll/HR Coordinator at marktalkoncorpcom
Brighton, MI 48114, USA - Full Time
Skills Needed
Discretion, Interpersonal Skills, Confidentiality
Specialization
Human resources accounting business or related field
Qualification
Trade Certificate
Bellstand Attendant at Marriott International Inc
San Francisco, CA 94108, USA - Full Time
Skills Needed
Access, Flexible Spending Accounts, Life Insurance, It
Qualification
Diploma
News Production Assistant at Audacy Inc
Los Angeles, CA 90036, USA - Full Time
Skills Needed
Office Equipment, Facebook, Presentations, Sports Radio, Instagram, X, Communications, Materials, Linkedin
Qualification
Graduate
Assistant Controller at Eastern Idaho Regional Medical Center
Idaho Falls, ID 83404, USA - Full Time
Skills Needed
Financial Statements, Close Process, Color, Travel, Relocation, Budget Preparation, Financial Analysis, Completion, Mental Health Care, Dignity, Journal Entries, Compassion, Common Sense
Specialization
CPA
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Senior Social Media Specialist at Pegasystems
Waltham, MA 02451, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 3 year(s)
AVP, Business Design & Solutioning – Client Solutioning at LPL Financial
Fort Mill, SC 29715, USA - Full Time
Skills Needed
Management Consulting, Financial Services, Product Management
Qualification
Graduate
RN Neuro Telemetry at Bakersfield Memorial Hospital
Bakersfield, CA 93301, USA - Full Time
Skills Needed
Addition, Wound Care, Computer Skills
Qualification
Graduate
Principal Product Manager - Artificial Intelligence at Splunk
California, California, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Senior Vice President Sales, Field Service Management at IFS
Itasca, Illinois, USA - Full Time
Skills Needed
Management Skills, Teams, Go, C Level, Manufacturing, Business Software, Complex Sales, Channel Partners
Specialization
Sales/Marketing
Qualification
MBA
North Lauderdale - Speech Language Pathologist/Speech Therapist - Therapy i at Sobe Innovative Rehab
North Lauderdale, FL 33068, USA - Full Time
Skills Needed
Speech Therapy, Physical Therapy, Occupational Therapy
Specialization
Speech therapy
Qualification
Graduate
Rheumatology APP in Thriving Tucson AZ at Banner Health
Tucson, Arizona, USA - Full Time
Skills Needed
Security, Communication Skills, Dea, Surf, Patient Care
Qualification
Graduate
Principal Software Systems Engineer at Baxter
Raleigh, North Carolina, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Loading...