Job Description

The responsibilities include, but not limited to:

• Provide regulatory guidance for new submissions (development of regulatory strategies, negotiate submission requirements with teams and Health Canada)
• Prepare regulatory submissions for new submissions and for the lifecycle management products, such as biosimilars (i.e. ANDS, NDS, SNDS, NCs, YBPRs, Annuals, PSUR and RMP)
• Performs gap assessments of regulatory dossiers (Modules 2 and 3) and ensures that Health Canada regulatory requirements are met
• Collect regional requirements and ensures templates for regulatory requirements in Canada are maintained current and any new requirements are communicated to all relevant stakeholders across the organization in a timely manner
• Represent the team in project update meetings with Global and Local teams
• As Specialist, mentor and assist Associates in understanding new regulatory requirements and further build their regulatory skillset
• Interact with authorities. -Communicate, address and solve problems within own and broader area of responsibility; communicate effectively across organizational interfaces

Minimum requirements :

• BSc (Pharmacy, Chemistry, Biochemistry or related) or equivalent experience and 5-8 years' experience within regulatory field
• Excellent oral and written communication skills in English and French
• Strong attention to detail, good sense of time management and ability to work in a team
• Interpersonal skills, customer focus and negotiation skills
• Ability to prioritize and handle many different priorities at the same time
• Excellent analytical thinking, attention to accuracy and respect of deadlines.

G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.We recruit based on talent alone and firmly believe that an individual's background should play no part in the recruitment and selection process.G&L is committed to everyone having the right to work in an environment free from the threat of discrimination, intimidation, harassment, and abuse.All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.(KO: 8277)Job Type: Full-timeSchedule:

• Monday to Friday

Language:

• English (required)
• French (required)