Project Manager, Regulatory Affairs Job - Canada
Today’s Merck is a
global health care leader with a diversified portfolio of prescription
medicines, vaccines and animal health products. Today, we are building a new
kind of healthcare company – one that is ready to help create a healthier
future 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 to
create an environment of mutual respect, encouragement and teamwork. As part of
our team, you’ll have the opportunity to collaborate with talented and
dedicated colleagues while developing and expanding your career.
The Project Manager, Regulatory Affairs
is responsible for all CMC submission requirements for assigned product
portfolio. The Project Manager is the regulatory contact with local
stakeholders and Global Regulatory Affairs and effectively collaborates with
Regulatory Clinical Units. This requires collaborative interaction with
component providers and other Regulatory Affairs Project Managers to ensure
quality, right first time output and timeliness. The Project Manager may also undertake other
additional activities including projects and leadership of team initiatives. The
position reports to the Associate Director, CMC Unit.
Activities and Responsibilities
- Coordinating the planning, preparation
and submission of global regulatory CMC-related submissions, including Marketing
Application(s) and post approval changes.
- Ensuring that all submissions are
complete, accurate and meet relevant requirements, and that they are prioritized
& filed so that there is no regulatory impact on supply.
- Management of CMC submissions and
follow up with Health Canada until final Health Canada regulatory decision.
This includes interacting with Health Canada and being a primary contact with
Health Canada with regards to the submissions.
- Interfacing with global Regulatory
partners and internal cross functional teams.
- HC requests (e.g., requests for
information) are assessed, communicated to management & Global &
managed as a priority & within required timelines.
- Filing and maintenance of CTA
submissions (CMC) with Health Canada and compliance with local and global SOPs.
- University Degree, B.Sc. or higher in Chemistry or
Health Sciences or equivalent, plus at least 2 years of experience in
regulatory affairs or a related function in a pharmaceutical and or
- Working Knowledge of Health Canada regulations,
guidance and policies, including a high
level understanding of the Health Canada regulatory requirements for CMC
- Experience with
biologics is an asset.
- Excellent time management
skills and the ability to work independently with minimal supervision.
- Outstanding interpersonal and communication (written and verbal) skills.
- Proficient with computer and standard software
programs, with excellent
word processing, presentation and spreadsheet application skills and the ability
to learn new computer interface systems.
- Detail oriented, with a high level of accuracy and
quality in work.
Bilingual (French and English)
Our employees are the key to our company's success. We
demonstrate our commitment to our employees by offering a competitive and
valuable rewards program. Merck's benefits are designed to support the
wide range of goals, needs and lifestyles of our employees, and many of the
people that matter the most in their lives.
Merck is an equal opportunity
employer, proudly embracing diversity in all of its manifestations.
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Job: Regulatory Affairs Generic
Job Title:Spclst, Regulatory Affairs
Primary Location: NA-CA-QC-Montreal (Kirkland)
Employee Status: Regular
Number of Openings: 1
Company Trade Name:Merck
Job Segment: Regulatory Affairs, Biotech, Law, Project Manager, Pharmaceutical, Legal, Science, Technology