Regulatory Affairs Director jobs in Pennsylvania

Director of Regulatory Affairs

Join Jubilant Radiopharma as our Director of Regulatory Affairs and be at the forefront of revolutionizing healthcare through innovative radiopharmaceuticals.

About Us: Jubilant Radiopharma is a dynamic leader in the development and distribution of cutting-edge radiopharmaceuticals, dedicated to advancing medical imaging and therapeutic solutions worldwide. We are committed to pushing the boundaries of science to improve patient outcomes and enhance lives.

Position Overview: As the Director of Regulatory Affairs, you will lead a talented team and drive regulatory strategies for our groundbreaking products, focusing on New Drug Applications (NDAs) and Biologic License Applications (BLAs). You will spearhead the preparation and submission of regulatory documents, ensuring compliance with stringent FDA regulations and facilitating productive engagements with regulatory agencies.

Key Responsibilities:

• Define regulatory strategies for products requiring NDA and BLA submissions, including Nuclear Medicine Imaging Tracers and therapeutic pharmaceuticals.
• Provide invaluable regulatory expertise to cross-functional teams, supporting business development initiatives and ensuring alignment with regulatory requirements.
• Champion compliance efforts, overseeing labeling, advertising issues, and maintaining up-to-date knowledge of regulatory changes.
• Lead and mentor a high-performing Regulatory Affairs team, fostering professional growth and excellence.
• Manage day-to-day operations, including budgeting, while executing additional responsibilities as assigned by management.

Qualifications:

• Master’s degree in Chemistry, Biochemistry, Regulatory Affairs, or related field; doctoral degree preferred.
• Minimum of 10 years’ experience in regulatory affairs within the pharmaceutical industry, with a focus on US FDA submissions.
• Expertise in NDA and BLA submissions, coupled with a strong understanding of regulatory frameworks.
• Exceptional communication skills, with the ability to navigate complex scientific and technical documents effectively.
• Detail-oriented and autonomous, with a knack for strategic thinking and analytical problem-solving.
• Proven leadership and management capabilities, with the ability to multitask and drive results in a fast-paced environment.

Why Join Us? At Jubilant Radiopharma, you’ll be part of a collaborative team dedicated to pushing the boundaries of medical innovation. We offer a dynamic work environment, competitive compensation package, and opportunities for professional growth and development. Join us in shaping the future of healthcare and making a meaningful impact on patients’ lives.

Apply Now: If you’re ready to embark on an exciting journey at the forefront of healthcare innovation, apply today and become a key player in our mission to revolutionize patient care. Let’s shape the future of radiopharmaceuticals together!

If qualified individuals with a disability need assistance in applying for this position, call Human Resources at 407-455-6700 informing us regarding the nature of your request and providing your contact information.

AA/DFWP/EOE –M/F/Individuals with Disabilities/Protected Veteran

Job Type: Full-time

EEO Notice of Rights

Equal Employment Opportunity is the Law.