Regulatory Manager Senior Regulatory Manager
Source: RemoteOK
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This role is for a Regulatory Manager or Senior Regulatory Manager responsible for providing regulatory strategy and guidance for clinical trials, ensuring timely and compliant submissions to regulatory authorities. The position offers an interesting opportunity to work with a CRO focused on Oncology and Rare Diseases, integrating clinical execution with scientific expertise and data sciences.
Job Description
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. Precision for Medicine are recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our team. The Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The Regulatory Manager coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. Essential functions of the job include but are not limited to: ⢠Provides regulatory guidance throughout the clinical development life cycle ⢠Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annPlease mention the word EASES and tag RMjAwMTo0MWQwOjMwMzo5NzdmOjox when applying to show you read the job post completely (#RMjAwMTo0MWQwOjMwMzo5NzdmOjox). This is a beta feature to avoid spam applicants. Companies can search these words to find applicants that read this and see they're human.
Full Description
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. Precision for Medicine are recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our team. The Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The Regulatory Manager coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. Essential functions of the job include but are not limited to: ⢠Provides regulatory guidance throughout the clinical development life cycle ⢠Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annPlease mention the word EASES and tag RMjAwMTo0MWQwOjMwMzo5NzdmOjox when applying to show you read the job post completely (#RMjAwMTo0MWQwOjMwMzo5NzdmOjox). This is a beta feature to avoid spam applicants. Companies can search these words to find applicants that read this and see they're human.