Assistant Director Of Regulatory Affairs
By NC Real Estate Commission At West Bend, NC, United States

Attorney needed to assist division director with supervisory and managerial responsibilities and to prosecute cases involving allegations of violations of Real Estate License Law and Commission ...

Sr. Director Of Regulatory Affairs
By Simply Biotech At North Carolina, United States
10+ years of management experience in Regulatory with direct reports.
Responsible for the preparation and management of IND, BLA, 510(k) and/or other appropriate market authorization applications for existing and new products
Knowledge of FDA, Health Canada (HC) and United States Department of Agriculture (USDA) guidelines and requirements
5+ years of Pharmaceutical Industry Experience
Experience submitting to the FDA, HC, and USDA
Experience reviewing, revising, and authoring INDs, BLAs, and 510(k)s

Are you looking for an opportunity to make a real impact in the healthcare industry? We are looking for a Director of Regulatory Affairs to join our team and lead our regulatory strategy. You will be responsible for developing and implementing regulatory strategies to ensure compliance with applicable laws and regulations. You will also be responsible for managing the regulatory process, including preparing and submitting regulatory documents, and providing guidance to internal and external stakeholders. If you are a strategic thinker with a passion for regulatory affairs, this is the perfect job for you!

Overview The Director of Regulatory Affairs is responsible for ensuring that the organization is compliant with all applicable laws and regulations. This includes developing and implementing strategies to ensure compliance, managing regulatory filings, and providing guidance on regulatory matters. Detailed Job Description The Director of Regulatory Affairs is responsible for developing and implementing strategies to ensure compliance with all applicable laws and regulations. This includes researching and analyzing laws and regulations, preparing and submitting regulatory filings, and providing guidance on regulatory matters. The Director will also be responsible for developing and maintaining relationships with regulatory agencies, monitoring changes in regulations, and providing training and guidance to staff on regulatory matters. Job Skills Required
• Knowledge of applicable laws and regulations
• Excellent communication and interpersonal skills
• Ability to research and analyze laws and regulations
• Ability to develop and implement strategies to ensure compliance
• Ability to develop and maintain relationships with regulatory agencies
• Ability to provide training and guidance to staff
• Ability to monitor changes in regulations
Job Qualifications
• Bachelor’s degree in a related field
• 5+ years of experience in regulatory affairs
• Knowledge of applicable laws and regulations
• Experience in developing and implementing strategies to ensure compliance
• Experience in developing and maintaining relationships with regulatory agencies
• Experience in providing training and guidance to staff
• Experience in monitoring changes in regulations
Job Knowledge
• Knowledge of applicable laws and regulations
• Knowledge of regulatory filing requirements
• Knowledge of regulatory agency requirements
• Knowledge of strategies to ensure compliance
• Knowledge of developing and maintaining relationships with regulatory agencies
• Knowledge of providing training and guidance to staff
• Knowledge of monitoring changes in regulations
Job Experience
• 5+ years of experience in regulatory affairs
• Experience in developing and implementing strategies to ensure compliance
• Experience in developing and maintaining relationships with regulatory agencies
• Experience in providing training and guidance to staff
• Experience in monitoring changes in regulations
Job Responsibilities
• Develop and implement strategies to ensure compliance with all applicable laws and regulations
• Research and analyze laws and regulations
• Prepare and submit regulatory filings
• Develop and maintain relationships with regulatory agencies
• Monitor changes in regulations
• Provide training and guidance to staff on regulatory matters