Associate, Regulatory Affairs

2 weeks ago

Mississauga, Canada Natco Pharma (Canada) Inc. Full time

**Associate, Regulatory Affairs**

Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated generic pharmaceutical company focused on research & development, and the manufacturing of active pharmaceutical ingredients (API) and finished drug product formulations.

The Regulatory Affairs department is responsible for the management of regulatory activities pertaining to drug products in Canada, from approval to marketing and lifecycle management. Furthermore, the department provides technical/scientific advice and support to Research and Development, Quality Control, Global Pharmacovigilance and Sales and Marketing. The department also interacts with relevant departments within Natco and external partners, domestic and international stakeholders, to ensure that products are submitted to Health Canada, approved, and launched in a timely manner. The department values communication, quality, teamwork, and efficiency.

**Job Summary**:
This position is for a Regulatory Affairs Associate who will contribute to the life cycle management of Natco Pharma (Canada) Inc’s product portfolio, with a focus on labeling update submissions to Health Canada. This position works with other departments, global teams and third parties to obtain necessary documentation/information for drug submissions to Health Canada in a timely manner.

**Accountability**:

- Coordinate with internal departments and third parties for obtaining necessary documentation for post-approval drug submissions to Health Canada (HC).
- Prepare and /or review post approval submissions to Health Canada in eCTD format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links.
- Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.
- Prepare and review product monographs for submission purposes. Maintain approved product monographs to comply with CRP-PMs.
- Request and review artwork that meets Health Canada’s plain language labelling requirements.
- Ensure that submissions sent to HC are of quality and meets internal timelines.
- Assess and update documentation for change controls in CMC and labeling according to quality change management systems.
- Publish high quality submissions in eCTD that meet the HC validation criteria.
- Monitor Canada’s pharmaceutical regulatory landscape and interpret HC’s guidance documents, policies, etc.
- Maintain departmental procedures/processes to ensure compliance with the Food and Drugs Act, HC regulations and other applicable industry standards.
- Other duties as required by management.
- Problem Solving and Decision Making/Autonomy: _
- Assist in resolving issues relating to submissions - Assess and respond to deficiency letters.
- Relationship with Internal/External Customers & Stakeholders: _
- Interact with applicable departments within Natco to determine solutions to regulatory issues.
- Communicate with external vendors and suppliers to obtain data relevant to submissions.

**Education/Licensing & ExperienceRequirements**
- Bachelor’s degree or equivalent in Chemistry, Pharmacy or Life Sciences.
- Diploma from an accredited Regulatory Affairs program would be preferred.
- 1-2 years of experience supporting drug product submissions to Health Canada
- Experience with eCTD submissions and knowledge of GMP and QA/QC procedures is preferred.
- eCTD publishing experience - use of docuBridge would be an asset.
- Excellent oral / written communication, organizational, time-management and interpersonal skills.
- Strong attention to detail.
- Strong computer skills (Proficiency with MS Office and Adobe Acrobat Pro, and Document Management Systems).
- Ability to plan, coordinate and work effectively in a team-oriented environment

This position is open to applicants legally authorized to work in Canada.

**Job Types**: Full-time, Permanent

**Salary**: $34,012.78-$53,756.58 per year

Schedule:

- 8 hour shift
- Monday to Friday

**Education**:

- Bachelor's Degree (required)

Work Location: Hybrid remote in Mississauga, ON

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