Full-Time Regulatory Affairs Manager

Manager of Regulatory Affairs will be responsible for the development, execution and tracking of regulatory submissions for assigned BicycleTx programs or projects.

Responsibilities

• Supporting the development of regulatory strategy and processes for assigned BicycleTx programs or projects, working closely with cross-functional colleagues and senior members of the Regulatory Affairs team.
• Serving as a subject matter expert for assigned activities, ensuring adherence to relevant regulatory requirements.
• Responsible for developing and executing global regulatory submissions for assigned BicycleTx programs or projects, including clinical trial applications.
• Maintaining regulatory files and tracking databases, including relevant parts of the trial master file.
• Collaborating with internal and external organizations to develop submission content plans and timelines.
• Supporting timely execution of regulatory submissions, responses to questions, audits and inspections.
• Preparing, drafting, reviewing, and analyzing risk for submissions (e.g., pediatric or orphan drug submissions).
• Developing and maintaining internal cross-functional relationships.
• Supporting the Global/Regional Regulatory Lead.
• Serving as primary contact with Health Authorities (HA) and external collaborators.
• Supporting the development of processes, SOPs and controlled documents.
• Partnering with Regulatory Affairs and cross-functional colleagues to understand the competitive landscape.
• Maintaining oversight of current and pending regulatory approvals.
• Maintaining working knowledge of laws, guidances, and requirements.

Qualifications

• Bachelor's degree in a scientific field or post-graduate degree preferred.
• Demonstrable experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Working knowledge of FDA, EMA, and ICH regulatory guidance and regulations.
• Experience in INDs, CTAs, or regional equivalents is desirable.
• Understanding of the drug product lifecycle.
• Experience and knowledge of key regulatory pathways (pediatrics, orphan drugs).
• Therapeutic experience in oncology is desirable.
• Ability to communicate on basic science topics, and working knowledge of global drug development.
• Ability to identify risks and develop risk mitigation strategies.
• Collaborative, strong communication and influencing skills.
• Strong organizational and time management skills.
• Adaptable and able to generate creative solutions.

What is the last date for applying to the job?

Which countries are accepted for this remote job?