Regulatory Affairs Manager - Chicago, IL
2 days ago

Job summary
The Regulatory Affairs Manager (CMC) position is responsible for authoring, review, preparation and management on-time filing of high-quality regulatory submissions with an emphasis on CMC.Responsibilities
- The primary responsibility will include authoring, reviewing and preparing high quality ANDA NDA BLA IND DMF submissions.
- Prepare review submit responses to FDA's CRLs DRLs Information Requests within predetermined negotiated deadlines.
Job description
, consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare.
Donec lacinia nisi nec odio ultricies imperdiet.
Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula.
Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit
, at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus.
Access all high-level positions and get the job of your dreams.
Similar jobs
Public Affairs Manager
4 hours ago
Ascend Wellness Holdings is seeking a Public Affairs Manager to drive our legislative and regulatory strategy in the cannabis industry. · ...
Regulatory Affairs Manager
14 hours ago
The Regulatory Affairs Manager (CMC) position is responsible for the author review preparation and manage on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC.The primary responsibility will include ...
Public Affairs Manager
1 month ago
About Ascend Wellness Holdings · Ascend Wellness Holdings (AWH) is a leading, · vertically integrated multi-state cannabis operator focused on building strong brands, · delivering best-in-class retail experiences and operating with discipline at scale. · EEO Statement: Ascend Wel ...
Manager Regulatory Affairs
4 hours ago
This position will support the company in regulatory issues and opportunities. The manager will help lead projects to ensure regulatory compliance and leverage regulatory opportunities to benefit Conagra Brands. · The role involves educating and influencing externally on food saf ...
Business Affairs Manager
4 weeks ago
The Business Affairs Manager works as the "right-hand" to the producers. They are responsible for handling the business details of producing television and radio commercials, · Review creative materials and advise Agency teams on talent, flag potential copyright issues and advise ...
Government Affairs Manager
1 month ago
+ Pro-actively scan the environment for key policy matters as they bubble up or track/trend in the civic /social, business and government spaces to ensure that through this radar activity the company stays abreast of any pending legislative/regulatory risks to develop a risk miti ...
Academic Affairs Manager
2 weeks ago
The Kenneth C. Griffin Department of Economics has been a global leader in economic research and education for more than a century.We have earned numerous prestigious awards, including more Nobel Prizes and John Bates Clark Medals in economics than any other university. · Our dis ...
Public Affairs Manager
1 month ago
About Ascend Wellness Holdings is seeking a Public Affairs Manager to drive our legislative and regulatory strategy in the rapidly evolving cannabis industry. The role will represent the company with policymakers and stakeholders while helping shape our long-term policy direction ...
Public Affairs Manager
1 month ago
Ascend Wellness Holdings is seeking a Public Affairs Manager to drive legislative and regulatory strategy in the cannabis industry.Represent Ascend at cannabis trade association meetings and industry forums. · Lead analysis of proposed legislative and regulatory actions, assessin ...
Regulatory Affairs Manager
1 month ago
The Regulatory Affairs Manager (CMC) position is responsible for authoring, reviewing, preparing high quality regulatory submissions and managing post-approval maintenance of regulatory dossiers with an emphasis on CMC. · Authoring, reviewing and preparing high-quality ANDA, NDA, ...
Manager Regulatory Affairs
1 month ago
This role supports the company in regulatory issues and opportunities. It involves leading projects to ensure regulatory compliance and leveraging opportunities to benefit Conagra Brands. · ...
Manager, Regulatory Affairs
4 weeks ago
We are seeking a Manager to play an integral role in ensuring that Capital One delivers on commitments to our regulators in a timely manner and proactively responds to the changing regulatory landscape. · ...
Manager Regulatory Affairs
1 month ago
Reporting to the Senior Director Regulatory Affairs you will support the company in regulatory issues and opportunities. · In this position you will help lead projects programs and/or processes to ensure regulatory compliance and to leverage regulatory opportunities to the benefi ...
Regulatory Affairs Manager
3 days ago
The Regulatory Affairs Manager (CMC) position is responsible for the author, review, preparation and manage on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC. · * Assimilate to changing environme ...
Business Affairs Manager
4 weeks ago
The Business Affairs Manager works as the right-hand to the producers. They are responsible for handling business details of producing television and radio commercials.Review creative materials and advise Agency teams on talent. · Work with Agency legal counsel on issues includin ...
Corporate Affairs Manager
1 month ago
Ascend Wellness Holdings is seeking a Corporate Affairs Manager to drive our legislative and regulatory strategy in the rapidly evolving cannabis industry. · ...
Manager, Medical Affairs Operations
1 month ago
+Job summary · The Medical Affairs Operations Manager role requires a combination of operational, project management, and quantitative skills to ensure that the day-to-day workflows are executed efficiently.+ResponsibilitiesCoordinate and track activities across Medical Affairs. ...
Regional Medical Affairs Manager
1 month ago
The responsibility of the Regional Medical Affairs Manager is to act as a regional medical and scientific expert. · Liaise and build peer-to-peer relationships with national and regional key opinion leaders (KOLs) · Align interests, discuss research, and communicate medical infor ...
Senior Business Affairs Manager
1 month ago
We design, implement and optimize breakthrough content production models delivering simplicity efficiencies and the connectivity and consistency of content that powers brand growth. · We bring ideas to life in all mediums all channels and all stages of the production process. We ...
Senior Business Affairs Manager
1 month ago
We design, implement and optimize breakthrough content production models, · delivering simplicity, efficiencies, and the connectivity and consistency of content that powers brand growth. · We bring ideas to life in all mediums, all channels and all stages of the production proces ...