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.

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.

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.