Regulatory Affairs Associate

**Overview**

**Roles & Responsibilities**:

- The RA/QA Associate is responsible for assisting in regulatory product submissions.
- Assist with monthly and annual reporting to all regulatory bodies.
- Assist in writing responses to regulatory bodies.
- Generate and investigate deviations and non-conformance reports. Identify and implement Corrective Actions.
- Assist in the creation of validation protocols and requalification programs. Coordinate and perform the test activities necessary to execute the validations. Review and summarize the results and conclusions of the validation.
- Review applicable literature to conduct assessments of safety and efficacy. Compile and prepare reports based on findings.
- Update, develop SOPs, and ensure timely implementation of the SOPs. Working with quality software’s like QMS and ERP
- Review batch records, Certificates of Analysis (CofAs), and other GMP documentation.
- Perform plant walkthroughs/audits and enforce SOPs/GMP requirements.
- Perform line clearance, start of batch procedures, sample collection, and end of batch reconciliation.
- Complete routine logbook entries as assigned by the RA/QA manager.
- Follow up on issues (e.g., GDP errors, OOS test results, etc.).
- Provide training to new hires or other employees as required.
- Assist the RA/QA manager in performing gap assessments of draft regulations to ensure remediation prior to regulations coming into effect.
- Prepare and participate in monthly management review meetings and take minutes.
- Other duties as assigned

**Education & Experience**
- Bachelor/Master's degree in science, pharmaceutical, Regulatory Science, Business, or a related discipline preferred, or relevant working experience.
- Minimum 1 year of professional related experience in Regulatory Affairs within Cannabis, pharmaceutical, or NHPs.
- Knowledge in chemistry and manufacturing, labeling relating to drug products. Knowledge of the Food and Drug Act, Title 21 CFR, and EU-GMP.
- Ability to adapt and interpret regulations from regulatory bodies worldwide

**Requirements**:

- Ability to pass an RCMP security clearance.
- Excellent oral and written communication skills. Fluent in English.
- Demonstrated strategic, process-driven, analytical, and critical thinking skills.
- Ability to work in a highly organized manner where attention to detail, accuracy, and confidentiality are critical.
- Proven time management skills and the ability to effectively manage multiple tasks of varying complexity with conflicting priorities in a busy working environment.
- Motivated and driven individual.
- Demonstrated ability to influence and work with all levels across the organization.
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).

**Physical Demands**

While performing the responsibilities of the job, the employee is required to lift up to and including 25lbs, sit and/or stand for extended periods of time and reach with arms/hands. Walking, climbing stairs, standing, and moving items are occasionally required. The employee must wear the required PPE to complete their job functions. The company reserves the right to modify PPE requirements based on regulatory, compliance and operational needs.

**Work Environment**

When employees are required to perform duties within the Manufacturing facilities, they may be exposed to unprocessed products/supplies. The Manufacturing environment can be temperate, noisy, and dusty at times. The employee will be provided with the appropriate (PPE) Personal Protective Equipment, and they must adhere to legal requirements regarding PPE to manage their own personal safety under these conditions. In addition, to ensure compliance and minimize contamination within a controlled environment, the employees may be required to wear latex gloves and a cleanroom suit.

Pay: $19.50-$25.00 per hour

Expected hours: 40 per week

Schedule:

- 8 hour shift
- Monday to Friday

**Experience**:

- ERP systems: 1 year (required)
- QMS : 1 year (required)

Work Location: In person