Fsp - Regulatory Affairs Associate

2 weeks ago

Montréal, Canada Calian Full time

Calian CRO is looking for a Regulatory Affairs Associate on behalf of our client for a limited 12-month term contract with a possibility of renewal. The role will be primarily remote, with occasional attendance in the Montreal office for meetings. Do you have a passion for day-to-day regulatory activities? If so, we would love to hear from YOU

Location
- Montreal, QCJob Type
- Full Time**Responsibilities**:

- Preparation of high quality regulatory submissions (e.g. CTA, CTA/A, SNDS) mostly related to changes in manufacturing sites and other post-approval activities
- Interact with local and global teams and provide input on regulatory plans for global products regarding clinical program, maintenance, technical transfers or new submissions
- May interact with Health Canada to ensure the successful planning, review and approval of drug submissions.
- Participate in multidisciplinary teams focusing on regulatory aspects of marketed products
- Assist the Regulatory managers with ongoing submissions and maintenance activities.
- Maintain tracking tools related to regulatory activities
- Ensure compliance of electronic systems, files and reports to facilitate the management and compliance of Drug Regulatory Affairs submissions, activities and records.
- Ensure compliance of company products and activities with the Food and Drug Act and Regulations, as well as existing and emerging Health Canada guidelines, policies and requirements; and industry association (eg Rx&D and PAAB) codes (e.g. labelling, advertising/promotions).
- Fulfill other duties as required

**Qualifications**:

- Degree in Science (BSc or equivalent)
- 1-4 years of regulatory experience preferred.
- Knowledgeable of regulatory processes in Canada.
- Excellent written and verbal communication.
- Excellent organizational, problem solving and interpersonal skills.
- Knowledge of Microsoft Office, excel, power point, Internet.
- Ability to work in an ever-changing environment and changing priorities.
- Must be able to work in an environment that involves multiple and concurrent projects.
- Flexible, team player, positive attitude and willingness to always learn more.
- Bilingual fluency in English and French.

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