Associate, Reg.affairs

**Job purpose**

Responsible for planning, completing, filing, obtaining approval and maintaining drug product registrations in Canada

**Duties and responsibilities**
- 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.
- Maintain current approvals and registrations through the filing of annual drug notifications.
- Provide regulatory guidance to Sun Pharma Canada Inc. (SPCI) and other Sun Pharma affiliates for all pre-submission, post-submission and post-market activities.
- Support other regulatory associates to ensure successful completion of assigned activities.
- Review and evaluate external dossiers.
- Communicate with Health Canada.
- Track and report milestones and regulatory activities to Manager, Regulatory Affairs
- Participate in assigned internal and external working groups.
- Assist in other filings to US and international markets, as required.

**Qualifications**
- Minimum Bachelor degree and 3 to 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.

**Working conditions**

Office based role

**Physical requirements**

Office based role

**Direct reports**

N/A