Senior Associate, Regulatory Affairs (Submission Coordinator) - 3 days/week

Canada, CA
March 13 2018
Organization Type
Requisition ID: ADM009312

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. With a diversified portfolio of prescription medicines, vaccines and animal health products, Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.   Merck’s Global Human Health (GHH) Division abides by a "patient first, profits later" ideology. Results-driven and ambitious, this team of individuals represents a functional balance between meeting company objectives and the needs of people around the world. The division is comprised of sales and marketing professionals who are passionate about their role in bringing Merck's prescription medicines, vaccines, and other medical products to our customers worldwide. Reporting to the Associate Director, the Senior Associate is responsible for ensuring that all documentation required to file submissions is properly prepared in accordance with the Food & Drug Act Regulations and Health Product and Food Branch Guidelines and Policies. He/She is responsible for the assembly of regulatory submissions and electronic archiving, tracking of regulatory product submission and ensuring that all official documentation, both electronic and paper, are organized and maintained in extensive departmental archives.
The Senior Associate will complete his/her tasks in a manner fully consistent with Merck’s commitment to its Code of conduct, Our Values and Standards, policies, procedures, industry standards and all laws and regulations.Qualifications

  • High School diploma is essential. A DEC in sciences would be an asset.


  • Minimum of 2 years of experience in an administrative support role in the pharmaceutical industry. Knowledge of medical, pharmaceutical and chemical terminology would be an asset.
  • Knowledge of the Merck Canada Inc. product line would be an asset.
  • Prior experience working on submissions to the government would be an asset. 

  • Bilingual French and English (written and oral).




  • Strong time management skills, ability to plan and organize workload in order to meet deadlines.
  • Must demonstrate attention to details, focus and precision.
  • Self-motivated, and capable of working independently with minimal supervision.
  • Good collaboration skills and ability to work  as part of a team.
  • Ability to work under pressure and on several projects simultaneously, all of which may have concurrent deadlines.
  • Demonstrated interpersonal and communication skills.
  • Must have experience with the MS Office suite, Adobe Acrobat and computer skills.
  • Excellent word-processing skills and spreadsheet application skills.
  • Continuous learning and problem-solving capabilities related to word-processing file conversions.

The Senior Associate models and demonstrates the Merck Leadership Standards in all interactions with employees, internal clients and external partners.



Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.  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.  

Search Firm Representatives Please Read Carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Job: Administrative Svcs Generic
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck