Position

Regulatory Affairs Specialist

Employment Permanent Date display: 02/12/2019 #Ref.:3478

Activity area : Pharmaceutical and medical

Post category : Scientific and technical positions

Province : Quebec

Region : Monteregie

Recruiter : Yannick Elbaz

Contact us : yelbaz@st-amour.com

Job description :

Under the supervision of the regulatory affairs director, the candidate will be involved in the preparation and submission of regulatory applications to various governmental agencies in Canada, US and Internationally (Europe).

 

On a day-to-day basis, the main responsibilities will be to:

  • Prepare IND, CTA submissions, including assessment of requirements for initial applications, amendments, annual reports and correspondence with Canadian, U.S. and European regulatory agencies.
  • Prepare of CMC sections and the required amendments, in collaboration with third-party partners (CMOs) and internal teams (R&D and quality).
  • Review protocols, reports and documentation to be used in submissions.
  • Actively participating in regulatory activities, including e-publishing services, medical writing services and CROs.
  • Write and prepare regulatory and scientific documents such as Orphan Drug Designations, Fast-Track Designation and other types of designation, annual reports to the FDA, DSUR, IB, IMPD, Product Monographs, Prescribing Information, Summary of Product Characteristics and labels.
  • Participate and collaborate in the development of NDS, NDA, MAA, DINA, PLA submissions by providing critical assessments pre-clinical, clinical and CMC information for new products (prescription, OTC and natural health products).
  • Prepare and review responses to the deficiency letters in timely manner.
  • Participate in other projects such as audits carried out by regulatory agencies.
  • Maintain current awareness of all regulatory guidelines.

Skills and qualifications :

  • A Bachelor’s degree in Chemistry or Life Sciences.
  • At least 5 years in a role directly related to regulatory affairs in which the acronyms IND, CTA, NDS, NDA, DINA and PLA were part of your daily life.
  • Developed a great understanding of manufacturing principles through your direct experience with CMCs.
  • Good working knowledge of Canadian regulations, guidance and policy, working knowledge of FDA requirements, and of other jurisdictions, is an asset.
  • Bilingual, French and English (oral and writing).