Position

Regulatory Affairs Manager (Labelling)

Employment Permanent Date display: 08/07/2019 #Ref.:3134

Activity area : Pharmaceutical and medical

Post category : Scientific and technical positions

Province : Quebec

Region : Monteregie, Montreal

Recruiter : Chantal Fillion

Contact us : cfillion@st-amour.com

Job description :

Our client, a leader in the generic industry is presently looking for a Regulatory Affairs Manager (Labelling) to join their growing team. You will support the achievements of key corporate milestones on a wide pool of generic products for submissions in Canada.

 

You will manage a team comprised of 3 people and will provide leadership and guidance for the development, revision, review, approval and maintenance of assigned product labels.   You will ensure timely distribution of preparatory documentation, identification of issues for discussion, and follow-up of action items to complete resolution.

 

You interact with business partners and affiliates in providing strategic guidance as appropriate to ensure consistency and compliance of product labelling.

 

Skills and qualifications :

  • Bachelor degree in Sciences.
  • Minimum of 2  to 3 years of professional related experience.
  • Knowledge of current regulatory requirements of Health Canada.
  • Experience in managing people will be an asset.
  • Detailed-oriented and very well organized.
  • Solid communication skills and ability to build strong relationships.
  • Good leadership and negotiation skills.
  • Bilingual in French and English (spoken & written).