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Associate, Regulatory Affairs

4 months ago

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

**About Natco**:
Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated pharmaceutical company focused on R&D and the manufacturing of drug products. We are a trusted supplier of medicines evidenced from our work with the world’s largest drug companies. Natco is renowned for trust, reliability, and commitment to our customers.

Natco Pharma (Canada) Inc. is headquartered in Mississauga and is supported by a strong cross-functional team.

We are currently looking 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 labelling 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.

**Duties and responsibilities**:

- 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 labelling 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.
- Assist in resolving issues relating to submissions - Assess and respond to deficiency letters.
- 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 & Experience Requirements**:

- 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 verbal and written communication, organizational, time-management and interpersonal skills.
- Proven 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.

**Salary**: $50,000.00-$65,000.00 per year

**Benefits**:

- Dental care
- Extended health care
- On-site parking
- Paid time off

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus pay

**Education**:

- Bachelor's Degree (required)

Work Location: Hybrid remote in Mississauga, ON L5N 1P7