Opus provides customized solutions to meet the challenges and restrictions faced by our clients - from startup biotechs to mid-to-large size pharmaceutical companies. The Principal Consultant ...
Opus provides customized solutions to meet the challenges and restrictions faced by our clients - from startup biotechs to mid-to-large size pharmaceutical companies. The Principal Consultant ...
About Opus Regulatory: For more than 30 years, Opus Regulatory has provided strategic guidance to ... from startup biotechs to mid-to-large size pharmaceutical companies. We're looking for several ...
About Opus Regulatory: For more than 30 years, Opus Regulatory has provided strategic guidance to ... from startup biotechs to mid-to-large size pharmaceutical companies. We're looking for several ...
Work from Home
Chandler, AZ · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Chandler, AZ · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Oklahoma City, OK · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Oklahoma City, OK · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Virginia Beach, VA · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Virginia Beach, VA · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Boise, ID · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Boise, ID · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Tucson, AZ · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Tucson, AZ · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Grand Junction, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Grand Junction, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Ogden, UT · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Ogden, UT · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Birmingham, AL · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Birmingham, AL · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Fort Collins, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Fort Collins, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Gilbert, AZ · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Gilbert, AZ · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Cincinnati, OH · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Cincinnati, OH · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Fort Collins, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Fort Collins, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Indianapolis, IN · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Indianapolis, IN · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Cleveland, OH · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Cleveland, OH · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Littleton, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Littleton, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Colorado Springs, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Colorado Springs, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Little Rock, AR · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Little Rock, AR · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Denver, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
Work from Home
Denver, CO · Remote
$18/hr
We are excited to announce that currently we are looking for a 100% remote (work from home-WFH) ... Primary Call Center contact for patients, pharmacies and medical professionals utilizing an Opus ...
From Home Opus Consulting information
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Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 22 days ago
Job description
About Opus Regulatory:
For more than 30 years, Opus Regulatory has provided strategic guidance to industry partners through expert consultants in key practice areas: Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of senior-level leaders and innovators provides project-specific contributions or ongoing support through the regulatory process. Opus provides customized solutions to meet the challenges and restrictions faced by our clients - from startup biotechs to mid-to-large size pharmaceutical companies.
The Principal Consultant, Regulatory Affairs Labeling Strategy is primarily responsible for the daily management of regulatory requirements for labeling strategy or labeling operations for one or more projects, designing and implementing labeling strategy, providing leadership to drive labeling consensus, and developing relationships with client subject matter experts and regulatory authorities. We have a robust client portfolio offering a variety of projects across therapeutic areas and regions.
Responsibilities include:
· Labeling experience across Development, Core, US, EU and Rest of World (ROW) Labeling.
· Understanding of end-to-end labeling process and systems.
· Lead preparation, review, and update content for the development and maintenance of Target Product Label (TPL), Company Core Data Sheet (CCDS), and local labeling and labeling components.
· Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory labeling, process, filing, best practices, etc. in conjunction with client leadership.
· Provide support and guidance to regulatory teams on RA requirements for one or more drug products by evaluating and communicating risks associated with CCDS content updates and implementation strategies.
· Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
· Develop and drive regulatory labeling timelines and deliverables.
· Understanding of labeling governance and process work.
· Support agency requests and documentation process for impact to labeling; participate in agency meetings as requested.
· Maintain knowledge of changing regulatory requirements and advise teams as appropriate.
· Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.
Qualifications:
· Must have a minimum of 4 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy.
· Bachelor's degree required; Advanced degree in a science discipline preferred.
· Experience across multiple therapeutic areas is highly desirable.
· Demonstrated global and international experience is required.
· Proven project management skills to support the planning and coordination of labeling submissions and support appropriate regulatory inspections.
· Ability to work independently and innovatively in tackling operational challenges.
Opus Regulatory is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Opus is committed to providing benefit-eligible employees with a comprehensive benefits package designed to support your health, financial well-being, and work-life balance. We offer medical, dental, vision, and prescription drug coverage for employees and their eligible family members. Additional benefits include Life Insurance, Short-Term Disability (STD), and an Employee Assistance Program (EAP), a 401(k) plan, and more. To support time away from work, we provide a paid time off package, which includes 20 vacation days, 5 sick days, & 10 paid company holidays annually.
About Opus Regulatory
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
11 - 50 Employees
Headquarters location
Cambridge, MA, US
Year founded
1994