Job
Description
As a regulatory affairs professional at Azurity Pharmaceuticals, you will play a crucial role in ensuring the success of the business by developing and implementing effective regulatory strategies. Your responsibilities will include: - Ensuring the development and implementation of robust regulatory strategies and plans for projects in development and approved, to meet the company's goals. - Providing regulatory guidance, requirements, and strategy for assigned projects to internal and external stakeholders, ensuring compliance with regulations and company standards. - Developing regulatory strategies for pipeline assets, considering necessary clinical and regulatory requirements for FDA approval. - Leading the execution of regulatory strategies for pre-approval and post-approval activities. - Oversight of regulatory team activities, including preparation and management of filings. - Conducting technical reviews of documents, providing regulatory expert advice, and ensuring completeness, accuracy, and regulatory compliance of submissions to the FDA. - Managing deficiencies received from the FDA within predefined timelines to secure approvals. - Performing regulatory gap analysis of applications and implementing corrective actions as needed. - Evaluating change controls and ensuring communication of necessary conditions and documents to cross-functional teams. - Fulfilling regulatory commitments submitted as part of applications and post-approval change supplements. - Providing regulatory support for leadership team meetings and presentations. Qualifications and Education Requirements: - Master of Pharmacy (M. Pharm) with a minimum of 15 years of pharmaceutical industry experience, including 10 years of regulatory experience. - Demonstrated passion for research, innovation, and willingness to work across diverse therapeutic areas. - Strong communication skills, strategic thinking, and sound understanding of drug development and regulatory approval processes. - Ability to work independently and collaboratively, handle multiple projects, and meet tight deadlines. - Proficiency in analytical skills, Excel, PowerPoint, and familiarity with intellectual property and licensing. In this role, you will need to meet physical and mental requirements such as sitting for long periods, occasional standing, walking, lifting up to 25 pounds, and operating electronic devices. Azurity Pharmaceuticals is committed to creating an inclusive workplace and is an Equal Opportunity Employer. The company values talent, dedication, and creativity in its team members, who are focused on improving patients' lives through science and quality commitment. If you are a highly motivated individual with integrity and a creative spirit, you will thrive in our organization. For more information, visit www.azurity.com. As a regulatory affairs professional at Azurity Pharmaceuticals, you will play a crucial role in ensuring the success of the business by developing and implementing effective regulatory strategies. Your responsibilities will include: - Ensuring the development and implementation of robust regulatory strategies and plans for projects in development and approved, to meet the company's goals. - Providing regulatory guidance, requirements, and strategy for assigned projects to internal and external stakeholders, ensuring compliance with regulations and company standards. - Developing regulatory strategies for pipeline assets, considering necessary clinical and regulatory requirements for FDA approval. - Leading the execution of regulatory strategies for pre-approval and post-approval activities. - Oversight of regulatory team activities, including preparation and management of filings. - Conducting technical reviews of documents, providing regulatory expert advice, and ensuring completeness, accuracy, and regulatory compliance of submissions to the FDA. - Managing deficiencies received from the FDA within predefined timelines to secure approvals. - Performing regulatory gap analysis of applications and implementing corrective actions as needed. - Evaluating change controls and ensuring communication of necessary conditions and documents to cross-functional teams. - Fulfilling regulatory commitments submitted as part of applications and post-approval change supplements. - Providing regulatory support for leadership team meetings and presentations. Qualifications and Education Requirements: - Master of Pharmacy (M. Pharm) with a minimum of 15 years of pharmaceutical industry experience, including 10 years of regulatory experience. - Demonstrated passion for research, innovation, and willingness to work across diverse therapeutic areas. - Strong communication skills, strategic thinking, and sound understanding of drug development and regulatory approval processes. - Ability to work independently and collaboratively, handle multiple projects, and meet tight deadlines. - Proficiency in analytical skills, Excel, PowerPoint, and famil
