Director Global Regulatory Affairs
The Judge Group, Phillipsburg, NJ, United States
Summary:
The Director, Global Regulatory Affairs is responsible for contributing to the development and execution of regulatory strategies and managing regulatory submissions for company’s products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory standards and efficient management of regulatory activities throughout the product lifecycle .
Prefer someone with strong NDA submission experience
Key Duties & Responsibilities:
Executes the defined regulatory strategy across the product portfolio. Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives. Submissions include IND's and NDA's (including 505(b)(2)), Annual Reports, amendments, Clinical Trial Applications, IND/NDA supplements, expedited program designation requests, and Pediatric Study Plans. Act as a primary regulatory point of contact for IND(s) , NDA(s) with the U.S. FDA. Collaborate with internal teams, such as R&D, Corporate Development, Quality Assurance, and Clinical, to ensure alignment of regulatory strategies with product development goal Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies. Perform critical review and provide strategic input on submission documents to ensure compliance with regulatory requirements, health authority guidance, and company policie Oversee the preparation, review, and submission of regulatory submissions to health authorities. Coordinate, prepare, and contribute to the development of document packages for regulatory submissions, including INDs, NDAs, meeting requests, meeting briefing documents, responses to FDA comments and IRs, DSURs/Annual Reports, clinical study protocols, clinical study reports, and application amendments for assigned projects. Lead regulatory project timelines, ensuring that deliverables are met in a timely and efficient manner, and resolve issues that may arise during the product lifecycle. Manage and mentor Regulatory Affairs direct report(s), providing guidance on regulatory issues, career development, and project management. Stay up-to-date with evolving global regulations and industry trends, ensuring that the company remains compliant with current standards and best practice
Qualifications: Minimum of a bachelor’s degree in a science-related discipline; RAC certification is a plus. Global regulatory experience in ICH regions and Canada is a plus. 10 to 15 years of relevant regulatory experience in pharmaceutical pharmaceutical/biotechnology experience, with extensive knowledge of all aspects of the drug development Must demonstrate recognized leadership qualities in previous roles. Strong project management skills is a plus. Strong knowledge of current US and global regulations/guidelines Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations team Proven ability to communicate with executive management and external thought leaders. Demonstrated identification of key regulatory risks.
Key Duties & Responsibilities:
Executes the defined regulatory strategy across the product portfolio. Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives. Submissions include IND's and NDA's (including 505(b)(2)), Annual Reports, amendments, Clinical Trial Applications, IND/NDA supplements, expedited program designation requests, and Pediatric Study Plans. Act as a primary regulatory point of contact for IND(s) , NDA(s) with the U.S. FDA. Collaborate with internal teams, such as R&D, Corporate Development, Quality Assurance, and Clinical, to ensure alignment of regulatory strategies with product development goal Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies. Perform critical review and provide strategic input on submission documents to ensure compliance with regulatory requirements, health authority guidance, and company policie Oversee the preparation, review, and submission of regulatory submissions to health authorities. Coordinate, prepare, and contribute to the development of document packages for regulatory submissions, including INDs, NDAs, meeting requests, meeting briefing documents, responses to FDA comments and IRs, DSURs/Annual Reports, clinical study protocols, clinical study reports, and application amendments for assigned projects. Lead regulatory project timelines, ensuring that deliverables are met in a timely and efficient manner, and resolve issues that may arise during the product lifecycle. Manage and mentor Regulatory Affairs direct report(s), providing guidance on regulatory issues, career development, and project management. Stay up-to-date with evolving global regulations and industry trends, ensuring that the company remains compliant with current standards and best practice
Qualifications: Minimum of a bachelor’s degree in a science-related discipline; RAC certification is a plus. Global regulatory experience in ICH regions and Canada is a plus. 10 to 15 years of relevant regulatory experience in pharmaceutical pharmaceutical/biotechnology experience, with extensive knowledge of all aspects of the drug development Must demonstrate recognized leadership qualities in previous roles. Strong project management skills is a plus. Strong knowledge of current US and global regulations/guidelines Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations team Proven ability to communicate with executive management and external thought leaders. Demonstrated identification of key regulatory risks.