Regulatory Affairs, Project Manager

MERCK
Posted

Post Expires

Type

Mid-level industry position

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Your Role:

As the Regulatory Affairs Project Manager, you will be responsible for the planning, submission and management of regulatory activities for both new and marketed products. This involves the development and implementation of regulatory strategies and the management of all regulatory submissions to lead to products with the earliest approvals and optimal labeling.  The successful candidate will have opportunity to manage projects across all phases of development and to cover all scientific areas of regulatory review (CMC, pre-clinical, and clinical).

You will liaise with Health Canada to support product registration process and ensure regulatory compliance. You will Interact with various global functions; in particular, Global Regulatory Affairs and Global Packaging Artwork Development. You will also partner with Quality Operations, Drug Safety, Medical Affairs and Supply Chain, and liaise with the Marketing function within the respective Canadian Therapeutic Area Business Units.

 

  • Bachelor’s degree in Life Science or relevant scientific discipline.
  • You have a minimum 5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry. 
  • Demonstrated knowledge of the Canadian Food and Drugs Act and Regulations and relevant Health Canada policies and guidance documents. 
  • Solid understanding of product development, including pharmacology, toxicology, pharmacokinetics and clinical studies.

Preferred Qualifications: 

  • Specific experience with Biological (BGTD) submissions is a strong asset.

Job Requisition ID:  198551 Working time model:  full-time

US Disclosure The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.North America Disclosure The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Toxicology, Biotech, Medical, Oncology, Project Manager, Science, Healthcare, Technology

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More Information

Posted

Post Expires

Type

Mid-level industry position

Mississauga%2C%20Canada

Mississauga , Canada