Regulatory Affairs, Senior Manager
The company I am currently working with is a pharmaceutical company in the clinical development phase, boasting an expanding and remarkable portfolio of therapies centered around neurology. They are committed to securing a brighter future for individuals who suffer from neurological disorders.
Take on the role of Regulatory Leader within multidisciplinary project and clinical study teams. Provide input on the documentation and procedural requirements set forth by Regulatory Authorities.
Create, review, contribute to, and edit submissions that facilitate the development process. This encompasses submissions like US Investigational New Drug (IND) applications, Canadian and/or European Clinical Trial Applications (CTAs).
Lead diverse teams in the preparation of responses to inquiries posed by Regulatory Agencies during the IND and CTA review phases for designated projects.
Ensure meticulous planning, tracking, and alignment of content and timelines for regulatory submissions across assigned indications and compounds.
Stay current with the latest regulations and guidance documents, interpret their implications, and promptly communicate relevant updates to appropriate colleagues and stakeholders.
Develop, review, and maintain Regulatory policies and other company-wide and departmental Standard Operating Procedures (SOPs).
Periodically engage in international travel for meetings and conferences.
A Bachelor's, Master's, or PhD in a scientific or medical field, accompanied by a minimum of 5 years of experience in Regulatory Affairs
Possession of specialised knowledge, skills, licenses, or certificates is preferred, with Regulatory Affairs Certification (RAC) being highly advantageous.
Demonstrated, hands-on expertise in the management and preparation of regulatory submissions, particularly in the context of Clinical Trial Applications outside of North America, with a primary emphasis on European applications through the Clinical Trials Information System (CTIS).
An established track record of successful submissions for clinical trials in Canada, the United States, and Europe is a prerequisite.
Proficiency in comprehending global regulatory requirements and staying informed about the evolving regulatory landscape is expected.
Ability to strike a balance between strategic thinking and robust analytical skills, coupled with the capacity to effectively execute tasks in a prioritized manner.
Capable of working both independently and collaboratively, as required, within a fast-paced team environment that includes internal and external team members.