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Project Manager, Regulatory Affairs Job Kirkland Canada,  


Posted on : 15 May 2017

Project Description

Project Manager, Regulatory Affairs-REG002916DescriptionToday s Merck is aglobal health care leader with a diversified portfolio of prescriptionmedicines, vaccines and animal health products. Today, we are building a newkind of healthcare company  one that is ready to help create a healthierfuture for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill,diversity and teamwork of an individual like you. To this end, we strive tocreate an environment of mutual respect, encouragement and teamwork. As part ofour team, you ll have the opportunity to collaborate with talented anddedicated colleagues while developing and expanding your career.The Project Manager, Regulatory Affairsis responsible for all CMC submission requirements for assigned productportfolio. The Project Manager is the regulatory contact with localstakeholders and Global Regulatory Affairs and effectively collaborates withRegulatory Clinical Units. This requires collaborative interaction withcomponent providers and other Regulatory Affairs Project Managers to ensurequality, right first time output and timeliness. The Project Manager may also undertake otheradditional activities including projects and leadership of team initiatives. Theposition reports to the Associate Director, CMC Unit.MajorActivities and Responsibilities- Coordinating the planning, preparationand submission of global regulatory CMC-related submissions, including MarketingApplication(s) and post approval changes.- Ensuring that all submissions arecomplete, accurate and meet relevant requirements, and that they are prioritized& filed so that there is no regulatory impact on supply.- Management of CMC submissions andfollow up with Health Canada until final Health Canada regulatory decision.This includes interacting with Health Canada and being a primary contact withHealth Canada with regards to the submissions.- Interfacing with global Regulatorypartners and internal cross functional teams.- HC requests (e.g., requests forinformation) are assessed, communicated to management & Global &managed as a priority & within required timelines.- Filing and maintenance of CTAsubmissions (CMC) with Health Canada and compliance with local and global SOPs.Qualifications- University Degree, B.Sc. or higher in Chemistry orHealth Sciences or equivalent, plus at least 2 years of experience inregulatory affairs or a related function in a pharmaceutical and orbiotechnology company.- Working Knowledge of Health Canada regulations,guidance and policies, including a highlevel understanding of the Health Canada regulatory requirements for CMCsubmissions- Experience withbiologics is an asset.- Excellent time managementskills and the ability to work independently with minimal supervision.- Outstanding interpersonal and communication (written and verbal) skills.- Proficient with computer and standard softwareprograms, with excellentword processing, presentation and spreadsheet application skills and the abilityto learn new computer interface systems.- Detail oriented, with a high level of accuracy andquality in work.- Language:Bilingual (French and English)Our employees are the key to our company's success. Wedemonstrate our commitment to our employees by offering a competitive andvaluable rewards program. Merck's benefits are designed to support thewide range of goals, needs and lifestyles of our employees, and many of thepeople that matter the most in their lives. Merck is an equal opportunityemployer, proudly embracing diversity in all of its manifestations. Search Firm RepresentativesPlease Read Carefully:Merck is not accepting unsolicited assistance from search firmsfor this employment opportunity. Please, no phone calls or emails.All resumes submitted by search firms to any employee at Merck via-email, theInternet or in any form and/or method without a valid written search agreementin place for this position will be deemed the sole property of Merck. Nofee will be paid in the event the candidate is hired by Merck as a result ofthe referral or through other means.Job: Regulatory Affairs GenericJob Title:Spclst, Regulatory AffairsPrimary Location: NA-CA-QC-Montreal (Kirkland)Employee Status: RegularNumber of Openings: 1Company Trade Name:Merck Job Segment: Regulatory Affairs, Biotech, Law, Project Manager, Pharmaceutical, Legal, Science, Technology

Locations

Montreal (Kirkland), QC, CA

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