Associate Director, Regulatory Affairs – CMC Small Molecules

Monte Rosa Therapeutics is looking for a skilled regulatory expert to fill the role of Associate Director, CMC Regulatory Affairs. The company focuses on developing innovative drug substances and products, particularly small-molecule glue degrader drugs. The Associate Director will be crucial in crafting and implementing global regulatory strategies for these products, ensuring they meet all necessary standards from the initial stages of development through to market approval. The main tasks of the Associate Director will involve creating and reviewing high-quality regulatory submission content, including detailed documentation and summaries. They will also act as the primary point of contact for regulatory matters, coordinating with various teams such as Process Chemistry, Analytical Development, and Quality Assurance. This role requires strong technical knowledge and the ability to manage multiple projects simultaneously, ensuring that all regulatory requirements are met efficiently. To excel in this position, candidates must have a Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related field, with an advanced degree being preferred. A minimum of eight years of experience in CMC Regulatory Affairs within the biotechnology or pharmaceutical industry is required, with direct experience in authoring Module 3 content for small-molecule programs. Proficiency in ICH guidelines, FDA and EMA regulatory requirements, and cGMP principles is essential. Additionally, experience with IND/CTA and NDA/MAA or BLA submissions is highly desirable. Nice-to-have skills include experience working with CDMOs/CMOs and cross-functional teams in an outsourced manufacturing model. Strong scientific writing and communication skills, along with the ability to manage multiple submissions and timelines, are also beneficial. The role offers the opportunity to contribute to the development of internal regulatory SOPs, templates, and best practices, supporting the company's growth towards late-stage development and commercialization. What the role asks for: - Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline - Minimum 8 years of progressive experience in CMC Regulatory Affairs within the biotechnology or pharmaceutical industry - Direct authorship of Module 3 content for small-molecule programs - Strong working knowledge of ICH guidelines - Strong working knowledge of FDA and EMA CMC regulatory requirements - Strong working knowledge of current Good Manufacturing Practice (cGMP) principles - Experience collaborating with CDMOs/CMOs and cross-functional technical development teams (nice-to-have)