Associate Director, Regulatory Affairs
The role
Navigator Medicines is building an immunology-first biotech focused on bispecific drug discovery for immunology and inflammatory diseases. The Associate Director, Regulatory Affairs (RA) is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory clinical trial application approval process (including US FDA INDs and other regulatory authorities) for Navigator reporting into the Head of RA & Quality.
The problems you'll work on
β’ Creating innovative global regulatory strategies for biologics throughout assigned product's lifecycle.
β’ Collaborating with cross-functional teams to ensure regulatory strategies align with corporate goals and evolving regulatory expectations.
β’ Ensuring regulatory compliance with evolving FDA and global regulatory expectations.
What you'll learn
β’ Acquire and maintain current knowledge of applicable regulatory requirements, scientific and technical issues in the discipline as relevant to assigned programs.
β’ Demonstrate advanced ability to have a flexible approach and adapt to change when need to alter the charted course.
β’ Establish best regulatory filing practices and implement new regulatory systems/process changes as part of continuous improvement opportunities.
How we work
β’ Provides strategic input on regulatory requirements, including benefit/risk assessments, and recommends regulatory solutions during early-to-late stage product development.
β’ Champions and cultivate a culture of quality within a diverse working environment.
β’ Brings unstoppable energy and enthusiasm to delivering top-quality results in a fast-paced, fun, and dynamic environment.
What You Bring
β’ Have a working knowledge of regulatory requirements specific to key regions such as the US, Canada, and EU, and have a general awareness of current global trends in Regulatory Affairs.
β’ Recognized as a leader, crew member, and possess a cross-functional collaborative skill set.
β’ Excellent oral and written communication and negotiation skills with strong attention to detail and clarity.
The salary range for this position is expected to be between $175,000 and $190,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.
About Navigator Medicines
Navigator Medicines is a clinical-stage biopharmaceutical company dedicated to advancing biologics for targeted immune regulation and restoration. Founded in 2024 as a subsidiary of Sera Medicines with $100M Series A financing co-led by RA Capital Management and Forbion, the company focuses on developing innovative therapies for complex autoimmune diseases. Navigator Medicines is committed to improving the lives of patients with heterogeneous conditions through cutting-edge science and groundbreaking advancements in immune therapeutics.
Legal & Equal Opportunity Notice
Navigator Medicines is an equal opportunity employer and provides reasonable accommodations as required by Massachusetts and California law.
Apply tot his job
Apply To this Job
Navigator Medicines is building an immunology-first biotech focused on bispecific drug discovery for immunology and inflammatory diseases. The Associate Director, Regulatory Affairs (RA) is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory clinical trial application approval process (including US FDA INDs and other regulatory authorities) for Navigator reporting into the Head of RA & Quality.
The problems you'll work on
β’ Creating innovative global regulatory strategies for biologics throughout assigned product's lifecycle.
β’ Collaborating with cross-functional teams to ensure regulatory strategies align with corporate goals and evolving regulatory expectations.
β’ Ensuring regulatory compliance with evolving FDA and global regulatory expectations.
What you'll learn
β’ Acquire and maintain current knowledge of applicable regulatory requirements, scientific and technical issues in the discipline as relevant to assigned programs.
β’ Demonstrate advanced ability to have a flexible approach and adapt to change when need to alter the charted course.
β’ Establish best regulatory filing practices and implement new regulatory systems/process changes as part of continuous improvement opportunities.
How we work
β’ Provides strategic input on regulatory requirements, including benefit/risk assessments, and recommends regulatory solutions during early-to-late stage product development.
β’ Champions and cultivate a culture of quality within a diverse working environment.
β’ Brings unstoppable energy and enthusiasm to delivering top-quality results in a fast-paced, fun, and dynamic environment.
What You Bring
β’ Have a working knowledge of regulatory requirements specific to key regions such as the US, Canada, and EU, and have a general awareness of current global trends in Regulatory Affairs.
β’ Recognized as a leader, crew member, and possess a cross-functional collaborative skill set.
β’ Excellent oral and written communication and negotiation skills with strong attention to detail and clarity.
The salary range for this position is expected to be between $175,000 and $190,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.
About Navigator Medicines
Navigator Medicines is a clinical-stage biopharmaceutical company dedicated to advancing biologics for targeted immune regulation and restoration. Founded in 2024 as a subsidiary of Sera Medicines with $100M Series A financing co-led by RA Capital Management and Forbion, the company focuses on developing innovative therapies for complex autoimmune diseases. Navigator Medicines is committed to improving the lives of patients with heterogeneous conditions through cutting-edge science and groundbreaking advancements in immune therapeutics.
Legal & Equal Opportunity Notice
Navigator Medicines is an equal opportunity employer and provides reasonable accommodations as required by Massachusetts and California law.
Apply tot his job
Apply To this Job