Bracco is an international Group active in the healthcare sector and a leader in diagnostic imaging. The Group’s main products are contrast agents sold in over 100 countries, both directly and indirectly through branches, joint ventures and license and distribution agreements. Regulatory Affairs encompasses roles focused on ensuring that products, such as pharmaceuticals, medical devices, and biologics, comply with all regulatory requirements and standards set by regulatory authorities. Professionals in this field work to prepare, submit, and manage regulatory documentation and liaise with regulatory bodies to facilitate product approvals and post-market surveillance. This job family is essential for bringing products to market legally and maintaining their compliance throughout their lifecycle. About Blue Earth Therapeutics: Blue Earth Therapeutics (BET) is a clinical stage radiopharmaceutical company dedicated to the advancement of next generation targeted radiotherapeutics to treat cancer patients. With proven leadership and therapeutic radiopharmaceutical expertise, Blue Earth Therapeutics has a strong pipeline of precision targeted radiopharmaceuticals. Their initial focus is on prostate cancer, with plans to expand to additional disease areas within cancer care. The approach of Blue Earth Therapeutics is to build on the progress seen with first generation radiopharmaceuticals with unique, targeted radio hybrid agents. About the Role: We are seeking an experienced and highly motivated Associate Director, Regulatory CMC to provide strategic leadership and technical expertise in Chemistry, Manufacturing, and Controls (CMC) regulatory affairs. This role will be instrumental in ensuring the success of our development pipeline, with a particular focus on NDA gap analysis and document development and FDA/EMA interactions. Writing and reviewing Investigational Medicinal Product Dossiers (IMPDs) and Investigational New Drug (IND) applications will also be in scope of this role. Ideal candidates will have experience in radiopharmaceuticals and a strong understanding of global CMC regulatory requirements. The successful individual will be required to work hands-on with regulatory submission document generation, while also being able to provide high-level strategic advice on future requirements and risk assessment. Key Responsibilities: Regulatory CMC Strategy & Compliance Develop and implement CMC regulatory strategies to support product development from pre-IND through Phase 3 and beyond. Ensure CMC documentation complies with global regulatory requirements, including FDA, EMA, and ICH guidelines. Stay current on evolving regulatory landscapes and communicate updates to internal stakeholders. Represent the company in regulatory agency interactions Regulatory Documentation & Submission Lead the preparation, review, and submission of high-quality IMPDs, INDs, and other CMC-related regulatory documents. Lead gap analysis of current data package for Ph3 and NDA readiness Ensure that all CMC submissions meet the highest standards of accuracy, completeness, and regulatory compliance. Collaborate with cross-functional teams, including Manufacturing, Quality, and R&D, to gather and integrate necessary data. IMP label management and regulatory oversight Radiopharmaceutical Expertise (preferred but not essential) Provide CMC regulatory support for radiopharmaceutical products, ensuring adherence to specific regulatory requirements. Guide teams on Good Manufacturing Practice (GMP) considerations for radiopharmaceuticals. Project & Stakeholder Management Oversee multiple CMC regulatory projects, ensuring timely execution of deliverables. Work closely with internal teams and external partners to align regulatory strategies with business objectives. Identify opportunities for process improvements and contribute to the enhancement of regulatory workflows. Qualifications and Experience: Education: Bachelor’s degree in Chemistry, Pharmacy, Life Sciences, or a related field (Advanced degree preferred: MSc, PhD). Experience: Minimum 10 years of experience in Regulatory CMC roles within the biopharmaceutical industry. Proven expertise in writing and reviewing IMPDs and INDs. Experience with radiopharmaceuticals is highly desirable but not essential. Strong knowledge of global regulatory CMC requirements, including FDA, EMA, and ICH guidelines. Skills & Competencies: Excellent technical writing and communication skills. Strong project management and organizational abilities. Ability to work collaboratively in a cross-functional team environment. Detail-oriented with analytical and problem-solving skills. Other Requirements: Ability to travel for regulatory meetings and industry conferences as needed. If you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply now! At Bracco, we believe in the values of diversity and inclusion. We respect and celebrate the diversity of our people and their experiences, ensuring a fair opportunity for all. We are Bracco JoinUs