Senior Associate, Regulatory Affairs (Pharma)
|Brampton, Ontario - Canada
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WHY IS THIS A GREAT OPPORTUNITY?
Our client in Brampton is presently looking for a Senior Associate to join our Regulatory Affairs Department who will be responsible for planning, completing, filing, obtaining approval and maintaining drug product registrations in Canada
- Manage and participate in preparation of submissions for Canada (DMFs, ANDS, NDS, S/NDSs, DINs, CTAs, NCs, etc.) for the successful registration of drug product.
- Manage and participate in preparation of submissions to support post approval changes through the filing of NCs and supplemental applications.
- Maintain current approvals and registrations through the filing of annual drug notifications.
- Provide regulatory guidance to the company and other affiliates for all pre-submission, post-submission and post-market activities.
- Support regulatory associates to ensure successful completion of assigned activities.
- Review submissions prepared by other team members in the department.
- Review and evaluate external dossiers.
- Communicate with Health Canada.
- Track and report milestones and regulatory activities to Director, Regulatory Affairs.
- Participate in assigned internal and external working groups.
- Assist in other filings to US and international markets, as required.
- Minimum B.Sc. in Chemistry, Pharmacy or Life Science.
- Minimum 5 years of experience in Regulatory Affairs.
- Expertise in eCTD submission requirements.
- Minimum B.Sc. in Chemistry, Pharmacy or Life Science and minimum 5 years of experience in Regulatory Affairs
- Expertise in eCTD filing requirements for chemistry and manufacturing, clinical/BE and labeling requirements for drug product registration and post-approval changes to TPD.
- Knowledge of GMP requirements and QA/QC procedures.
- Excellent interpersonal, written and verbal communication skills.
- Ability to plan, coordinate and work effectively in a team-oriented environment.
Excellent problem solving abilities required to determine optimal regulatory strategies pertaining to new drug submissions, responses to deficiency letters and post-approval issues
** Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc..