About Us
About the Role
The Manager, Regulatory Affairs will support global development programs in collaboration with key stakeholders.
Reporting to the Senior Vice President, Regulatory Affairs, you will support regulatory activities and contribute to department initiatives. This position will focus on clinical trial applications (CTAs), regulatory planning, and facilitating global submissions as we work toward bringing innovative therapies to market.
This is a unique opportunity to join a growing organization with an expanding pipeline, and to play an integral role in the creation and implementation of regulatory strategies from early development through marketing approval. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.
Key Responsibilities
- Ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions, including Investigational New Drug (IND) applications, clinical trial applications, IND/CTA amendments, notifications, and reports.
- Represent regulatory at study management team meetings.
- Liaise with CRO to ensure that a comprehensive list of country requirements and potential challenges is generated and communicated to team.
- Facilitate health authority query management and submission of responses, including scheduling of cross-functional team meetings.
- Contribute to preparation of submission components in conformance with regulatory requirements and strategies to ensure high quality and timely submissions.
- Maintain accurate records of communications with health authorities and track application status.
- QC regulatory components of Trial Master Files for accuracy and completeness
- Create and manage health authority query and commitment trackers.
- Assist global regulatory leads with execution of regulatory strategies.
- Build and apply knowledge of FDA, EU Clinical Trial Regulation, and other international regulatory requirements for clinical trials to determine potential risks, impacts, and mitigations.
- Support departmental initiatives, including process and infrastructure development.
Experience
- Bachelor's degree required.
- Experience within the biotech or pharmaceutical industry required; rare disease and/or neurology product experience a plus
- Understanding of regulatory requirements for drug development and approval
- Demonstrated problem-solving ability, flexibility, and teamwork
- Experience in preparing and submitting CTAs, INDs, and other regulatory documents
- Excellent written and verbal communication skills with attention to detail
- Strong organizational and project management skills
- Good interpersonal skills and the ability to work collaboratively across departments and with external partners
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