Job
Description
As a Regulatory Director at Azurity Pharmaceuticals, your role is crucial in analyzing regulatory and clinical information to determine optimal pathways and strategies for potential drug products. Reporting to the Vice President of Regulatory Affairs, you will collaborate with cross-functional teams to develop regulatory strategies for new product development and potential indications. Additionally, you will oversee Advertising/Promotional Review Teams, providing regulatory insight aligned with FDA guidelines. **Key Responsibilities:** - Develop and implement clinical regulatory strategies, including Modeling Informed Drug Development (MIDD) and real-world data analysis. - Assess regulatory approval factors such as pharmacokinetics and post-marketing safety studies. - Evaluate current regulatory pathways to identify future development opportunities. - Present research findings to senior leadership for alignment on regulatory strategy. - Interface with regulatory agencies and lead commercial regulatory strategy for promotional materials. - Oversee the MLR review committee and provide guidance on advertising regulations. - Recruit, develop, and mentor team members while ensuring regulatory compliance. **Qualifications Required:** - Bachelor's degree in Life Science or related field; advanced degree preferred (MS, PharmD, PhD). - Minimum 10 years of pharmaceutical industry experience with at least 5 years in regulatory roles. - Proficiency in Advertising/Promotional regulations and strategy development. - Strong communication skills, strategic thinking, and ability to handle multiple projects in a fast-paced environment. - Demonstrated leadership in fostering teamwork and efficiency. Azurity Pharmaceuticals, known for its patient-centric products in various therapeutic areas, fosters an inclusive workplace culture and values talent that contributes to improving patient lives through innovative science and quality commitment. If you are motivated, dedicated, and creative, you will find a rewarding career at Azurity. For more information about Azurity Pharmaceuticals, please visit www.azurity.com. As a Regulatory Director at Azurity Pharmaceuticals, your role is crucial in analyzing regulatory and clinical information to determine optimal pathways and strategies for potential drug products. Reporting to the Vice President of Regulatory Affairs, you will collaborate with cross-functional teams to develop regulatory strategies for new product development and potential indications. Additionally, you will oversee Advertising/Promotional Review Teams, providing regulatory insight aligned with FDA guidelines. **Key Responsibilities:** - Develop and implement clinical regulatory strategies, including Modeling Informed Drug Development (MIDD) and real-world data analysis. - Assess regulatory approval factors such as pharmacokinetics and post-marketing safety studies. - Evaluate current regulatory pathways to identify future development opportunities. - Present research findings to senior leadership for alignment on regulatory strategy. - Interface with regulatory agencies and lead commercial regulatory strategy for promotional materials. - Oversee the MLR review committee and provide guidance on advertising regulations. - Recruit, develop, and mentor team members while ensuring regulatory compliance. **Qualifications Required:** - Bachelor's degree in Life Science or related field; advanced degree preferred (MS, PharmD, PhD). - Minimum 10 years of pharmaceutical industry experience with at least 5 years in regulatory roles. - Proficiency in Advertising/Promotional regulations and strategy development. - Strong communication skills, strategic thinking, and ability to handle multiple projects in a fast-paced environment. - Demonstrated leadership in fostering teamwork and efficiency. Azurity Pharmaceuticals, known for its patient-centric products in various therapeutic areas, fosters an inclusive workplace culture and values talent that contributes to improving patient lives through innovative science and quality commitment. If you are motivated, dedicated, and creative, you will find a rewarding career at Azurity. For more information about Azurity Pharmaceuticals, please visit www.azurity.com.
