Regulatory Compliance & Enforcement Officer

Update: The poster has been extended until June 20, 2022.

Important messages

We are committed to providing an inclusive and barrier-free work environment, starting with the hiring process. If you need to be accommodated during any phase of the evaluation process, please use the Contact information below to request specialized accommodation. All information received in relation to accommodation will be kept confidential.

Assessment accommodation

***VERY IMPORTANT NOTE: It is the responsibility of the candidate to clearly outline that they meet each of the screening criteria (i.e., Education and Experience Qualifications, both Essential and Assets) by RESPONDING TO THE SCREENING QUESTIONS IN THE ONLINE APPLICATION. Please note that it is not sufficient to only state that the requirement is met or to provide a listing of current responsibilities, rather, the candidate must provide concrete examples that illustrate how they meet the requirement. Lack of EXAMPLES and DETAILS may result in your application being rejected, as the Assessment Board will have insufficient information to determine whether or not you meet the qualifications.

EVERYONE IS WELCOME
Health Canada and the Public Health Agency are dedicated to building an inclusive workforce with a diversity of experience, perspectives, and backgrounds that represents Canada now and in the future. We are passionate about fostering a workplace where all people feel welcome, can reach their full potential, and contribute their unique perspectives and experience to the success of the team.

BRING YOUR WHOLE SELF TO WORK
We encourage all qualified candidates to apply, regardless of race, colour, religion, sex (including gender identity and/or expression), national origin, sexual orientation, civil union or relationship status, disability, age, parental status, military service, or other status protected under federal law.

In addition to your resume, you must clearly demonstrate IN YOUR ANSWERS TO SCREENING AND TEXT QUESTIONS how you meet the essential qualifications regarding the education and experience criteria. You must detail where and when you obtained the education and experiences, including the educational institution, and by identifying the employer(s) or organization(s) where you obtained the required experience factors, as well as concrete examples demonstrating your experiences. Failure to follow these instructions may result in your application being rejected.

HOW CAN YOU APPLY?
Please note that only applications received directly via Jobs GC will be accepted.

Work environment

Are you interested in working at a cutting-edge organization that values both your physical and psychological health and wellness, provides rich career development opportunities and rewards innovation? Health Canada is among Canada’s Top 100 Employers for 2021 in addition to being recognized as Top employer for Young People since 2015 and as Best Diversity Employer since 2010! Don’t miss your opportunity to not only enjoy the unparalleled benefits of the public service, but to get so much more on our award-winning team!

Intent of the process

Applicants should be aware that a pool of qualified candidates (fully assessed or partially assessed) may be established and may be used to staff similar positions at this group and level with various language requirements listed in the Language Requirements section. In addition, this process may be used for various tenures (acting appointments, assignment, deployment, indeterminate, specified period and secondment), security requirements and conditions of employment within Health Canada. As a result of the potential and possible use of the selection process and subsequent pool by hiring managers, we encourage all employees seeking this type of opportunity to apply.

Positions to be filled: 2

Information you must provide

Your résumé.

In order to be considered, your application must clearly explain how you meet the following (essential qualifications)

Education:

Graduation with a degree from a recognized post-secondary institution with acceptable specialization in microbiology, chemistry, chemical engineering, pharmacy or some other specialty related to the position.

Note:
Degree: Unless it is otherwise specified (e.g., Master’s degree), the term “degree” refers to a baccalaureate as established by educational authorities.

The courses for the specialization must be acceptable and must have been taken at a recognized post-secondary institution, but not necessarily within a degree program in the required specialization.

Degree equivalency

Experience:

EX1: Work experience* in the production, (including validation and engineering) and/or quality control (including product release and analysis, investigations into deviations and out of specifications, change control) of marketed drug products (medicines) or marketed natural health products.

OR

EX2: Work experience* in conducting good manufacturing practices inspections or audits and/or other compliance and enforcement activities with respect to marketed drug products (medicines) or marketed natural health products.

*Work experience is generally defined as a minimum of two (2) years within the past five (5) years.

If you possess any of the following, your application must also clearly explain how you meet it (other qualifications)

AEX1: Working experience* related to sterile product fabrication in compliance with established standards/regulations.

AEX2: Working experience* related to biological product fabrication in compliance with established standards/regulations.

AEX3: Working experience* related to radiopharmaceutical product fabrication in compliance with established standards/regulations.

AEX4: Working experience* related to good pharmacovigilance (GVP) activities in the pharmaceutical drugs industry.

* Working experience is generally defined as a minimum of two (2) years within the last five (5) years.

The following will be applied / assessed at a later date (essential for the job)

Bilingual - Imperative (BBB/BBB)

Information on language requirements

Knowledge:
K1: Knowledge of the policies and guides applied by the Regulatory Operations and Enforcement Branch (ROEB) to the regulated industry, with respect to compliance and enforcement for drugs and natural health products. (POL-0001, POL-0016 and GUI-0001)

K2: Knowledge of the Food and Drugs Act and associated regulations for drug products (medicines) and natural health products.

Abilities:
A1: Ability to communicate effectively orally
A2: Ability to communicate effectively in writing

Personal Suitabilities:
PS1: Reliability: Consistently performs work reliably and consistently, while recognizing the importance of personal responsibility and commitment to colleagues, clients and the organization.
PS2: Thinking things through: Examine all aspects of an idea, situation or problem in an open approach, identify the best solution/direction and take appropriate action in a timely manner.
PS3: Work effectively with others: Make a significant contribution to collective efforts to achieve established goals, including having good interpersonal relationships and team spirit.
PS4: Being action-oriented: Understand internal and external customer needs and meet them according to defined service standards.
PS5: Respect for Diversity: Demonstrate respect for diversity.

Conditions of employment

Reliability Status security clearance

Possession of a valid Driver’s License
Availability, willingness, and ability to travel, as required, regionally, nationally, and internationally, possibly on short notice.
Availability, willingness, and ability to work overtime, as required.
Availability, willingness, and ability to work on statutory holidays, as required.
Ability to obtain and maintain a valid Canadian passport, as needed.
Fully vaccinated against COVID-19 unless accommodated due to certified medical contraindications, religion, or other prohibited grounds under the Canadian Human Rights Act.

Please note: Candidates must meet and maintain the above conditions of employment throughout their employment.

Other information

The Public Service of Canada is committed to building a skilled and diverse workforce that reflects the Canadians we serve. We promote employment equity and encourage you to indicate if you belong to one of the designated groups when you apply.

Information on employment equity

Effective October 6, 2021, the Government of Canada implemented a new Policy on COVID-19 Vaccination for the Core Public Administration Including the Royal Canadian Mounted Police, impacting the core public administration. This policy requires that all new hires on or after the effective date of the policy be fully vaccinated against COVID-19 as a condition of employment, and to attest that they are fully vaccinated prior to their start date unless accommodated due to certified medical contraindications, religion, or other prohibited grounds under the Canadian Human Rights Act.

In support of achieving a diversified workforce, consideration may be given to candidates self-declaring as belonging to one of the following Employment Equity groups: Aboriginal peoples, Persons with disabilities, Members of visible minorities, and Women.

An interview may be administered.

A written examination may be administered.

A minimum of two professional references will be requested and checked, one of which must be an immediate supervisor (for a minimum of 6 months) within the last 3 years of employment.

A “Top Down” assessment process may be used during any stage of the selection process. Please note that simply meeting the essential qualifications and/or achieving a pass mark on any of the assessment used does not mean you will move forward in the selection process. Management may decide to use breadth and depth of the screening criteria, assessed qualifications (including Asset qualifications) and/or a cut-off mark that is higher than the pass mark on any evaluation used throughout the process.

Persons are entitled to participate in the appointment process in the official language of their choice. Applicants are asked to indicate their preferred official language in their application

Acknowledgment of receipt of applications will not be sent; we will contact candidates when the screening process is completed.

You must provide proof of your education credentials and citizenship.

Candidates who have been fully assessed and found to have met all essential qualifications except official language requirements may update their second-language evaluation (SLE) results for as long as the pool is valid. N.B.: Each candidate can only undergo SLE testing one time within the context of an appointment process; any update to a candidate's linguistic profile must be as a result of subsequent SLE testing done outside of this appointment process.

All candidates that apply to this selection process must include in their application a valid email address and ensure that this address is functional at all times and that it accepts messages from unknown users. Failure to do so may result in important messages not being received. Communication for this process will be conducted via the e-mail address provided in your application. It is your responsibility to ensure that you check for messages regularly.

Candidates must meet each essential qualification to be appointed to the position. A candidate may be appointed to the position even though he/she does not meet any or all of the asset qualifications, operational requirements or organizational needs. However, meeting these criteria is desirable and may be a deciding factor in choosing the person to be appointed. In the event that there are as many candidates who meet the essential qualifications as there are vacancies, the manager may decide not to assess some or all of the asset qualifications, operational requirements or organizational needs.

Preference

Preference will be given to veterans first and then to Canadian citizens and permanent residents, with the exception of a job located in Nunavut, where Nunavut Inuit will be appointed first.

Information on the preference to veterans

We thank all those who apply. Only those selected for further consideration will be contacted.