Global Regulatory Lead
Opella, Morristown, TN, United States
About The Job
The Global Regulatory Lead supports the regulatory strategy for bringing new drugs, medical devices, and combination products to market. It involves preparing and managing key submissions like INDs and NDAs while coordinating with internal teams. The position also helps plan and participate in meetings with regulatory agencies such as the FDA. Additionally, it includes reviewing product labeling and advertising to ensure compliance, analyzing regulations, and monitoring competitor approvals. The role works cross-functionally to provide scientific and regulatory input on projects and ensures products meet all regulatory requirements throughout their lifecycle.
Main Responsibilities
Provide assistance in developing and implementing the regulatory strategy for new products/claims for different regulatory classes (drug, medical device, combination products).
Lead the operational execution of regulatory submissions for NDA products working with electronic document specialists and publishers.
Prepare IND submission documents aligned with the regulatory strategy and support lifecycle management of the IND.
Support the planning of meetings with regulatory agencies as appropriate, including participation in agency meetings on specific topics.
Review and approve labeling and advertising for NDA products; review concept review, commenting and approval, competitive challenge research/responses.
Assist in the analysis and interpretation of government medical device regulations.
Research competitive product approval status and emerging FDA requirements to support switch programs.
Support Global Regulatory Affairs initiatives.
Contribute to interdepartmental projects and provide scientific and technical information.
Represent Regulatory Affairs by participating in approved projects and programs.
About You
Bachelor's Degree Required
About 3-5 years of relevant regulatory experience across multiple regulatory classes (NDA, Monograph, Medical Device).
Good written and verbal communication skills, with the ability to present complex information clearly and concisely to both internal and external stakeholders.
Experience in compiling regulatory dossier and executing FDA submission.
The Salary Range For This Position Is 111,000.00 - 130,000.00 USD Annual
Equal Opportunity Employer Opella Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#J-18808-Ljbffr
Main Responsibilities
Provide assistance in developing and implementing the regulatory strategy for new products/claims for different regulatory classes (drug, medical device, combination products).
Lead the operational execution of regulatory submissions for NDA products working with electronic document specialists and publishers.
Prepare IND submission documents aligned with the regulatory strategy and support lifecycle management of the IND.
Support the planning of meetings with regulatory agencies as appropriate, including participation in agency meetings on specific topics.
Review and approve labeling and advertising for NDA products; review concept review, commenting and approval, competitive challenge research/responses.
Assist in the analysis and interpretation of government medical device regulations.
Research competitive product approval status and emerging FDA requirements to support switch programs.
Support Global Regulatory Affairs initiatives.
Contribute to interdepartmental projects and provide scientific and technical information.
Represent Regulatory Affairs by participating in approved projects and programs.
About You
Bachelor's Degree Required
About 3-5 years of relevant regulatory experience across multiple regulatory classes (NDA, Monograph, Medical Device).
Good written and verbal communication skills, with the ability to present complex information clearly and concisely to both internal and external stakeholders.
Experience in compiling regulatory dossier and executing FDA submission.
The Salary Range For This Position Is 111,000.00 - 130,000.00 USD Annual
Equal Opportunity Employer Opella Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#J-18808-Ljbffr