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Project manager • salaberry de valleyfield qc
CMC Regulatory Project Manager - Consultant, FSP (US or Canada)
ParexelRemote, Quebec, CanadaIncident Response Manager
CENTRIC SOFTWARE INCRemote USA or Canada, QC, CAGestionnaire Adjoint de Programme,, Bilingue / Bilingual Associate Program Manager
Innomar StrategiesCAN > QC > Remote- Promoted
Remote Product Tester - No Experience
OCPAQuebec, CAQA Engineer
Produit Folie Canada Inc.Remote, QuebecEntry-Level Market Researcher (Remote)
FocusGroupPanelSaint-Georges-de-Cacouna, Quebec, CanadaSenior Analyst, Enterprise Analytics
ZendeskRemote, Quebec, CanadaConseiller en architecture intermédiaire / sénior - sécurité des données
TEHORAQC, CATechnical Project Manager [#4763]
Alteo100% Remote, QC, CanadaScrum Master
Solution SFTQC, CALead Software Developer - Montreal
Snowed In StudiosQC, CAFull Stack Developer - Senior
Big Fish GamesRemote, QuebecOncology Key Account Manager
TakedaCAN, Remotereprésentant(e) principal(e) des Comptes majeurs (HUNTER) — grandes entreprises / Major Accounts, District Manager
ADPN / A - Home Address, CAN - QC Home Office, QC, CACustomer Service Supervisor - Bilingual
Graymont LimitedQC, Remote, CanadaSpecification Writing Apprentice
Allegion Canada Inc.Remote, QuebecCustomer IP Solution Architect
Ciena Communications, Inc.Bldg C, Terry Fox,Ottawa,CanadaAdministrative Assistant - Retail Operations
Home Hardware StoresRemote, Quebec, CanadaIngénieur.e en planification et contrôle de projet (télétravail possible)
Strana Talent Inc.Tous les bureaux de GCM / All GCM Offices, Québec, CanadaCustomer Success Manager
Iron MountainRemote, QC, CACMC Regulatory Project Manager - Consultant, FSP (US or Canada)
ParexelRemote, Quebec, Canada- Remote
When our values align, there's no limit to what we can achieve.
If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you!
Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented Regulatory CMC Project Manager to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department.
Key Responsibilities :
Collaborative Coordination : Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC / Module 3 submission deliverables. This includes managing start / end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions.
Strategic Planning : Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements.
Project Management : Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed.
Regulatory Support : Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards.
Health Authority Engagement : Support the preparation of materials for health authority engagements
Qualifications :
Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management).
3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls).
Strong project management skills with a track record of managing complex projects and meeting deadlines.
Excellent organizational and communication skills.
Excellent time management abilities
Proficient in Microsoft Office Suite
Strong communication and interpersonal skills
Ability to work collaboratively in a fast-paced, dynamic environment.
Additional Requirements :
Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones
LI-LB1
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.