Associate Director, Manager Regulatory Affairs Compliance

1 month ago

Laval, Canada Altasciences Full time
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At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.The Associate Director, Regulatory Affairs and Submissions, is responsible for providing regulatory guidance to Sponsors related to drug development and submission requirements, leading the initiation (requests), preparation (meeting packages), and conduct of a variety of Agency interactions (Type A – C, INTERACT meetings), leading regulatory submission preparation (including assessing for gaps in requirements) and filing activities, may act as a project resource for junior staff/peers to ensure workload is managed, strategies are aligned, and submissions are of the highest quality.Work closely with business development team and sponsors to understand sponsor’s needs and interests, and to provide regulatory guidance related to drug development and submission preparation.Interact with sponsors as a regulatory consultant to build trust and encourage engagement.Evaluate, develop, plan and prepare regulatory submissions (INDs primarily) for new drugs under development with the collaboration of multiple cross-functional teams.Perform gap analysis for drug development programs and to inform regulatory strategies.Lead, manage and prepare clinical trial submissions.Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies.Participate in sponsor’s audits and regulatory inspections.Provide regulatory input into client-provided proposals.Coordinate with internal teams to deliver high-quality documents in accordance with agreed upon timelines.Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines.Participate in departmental or interdepartmental quality improvement initiatives.MSc/MS, PhD in a relevant field; 5+ years of predominantly US regulatory experience in an industry setting.Strong knowledge of drug development and regulatory policy including ICH, FDA, and Health Canada guidelines related to early phase drug development.Demonstrated experience with leading IND submissions in US, experience with other regulatory agencies an asset.Ability to assess nonclinical data for gaps in an IND-enabling package.Flexible attitude with respect to work assignments and new learning.Thorough understanding of clinical research, drug development process and applicable regulatory guidance.Strong computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems.Experience with Health Canada is an asset. p>Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.Health/Dental/Vision Insurance Plans.Paid Vacation and Holidays.Telework when applicable.Training & Development Programs.Annual Performance Reviews.Altasciences is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request.

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