Regulatory Compliance and Enforcement Officer - Anticipatory

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

Please note that this job opportunity is re-advertisement of the process 21-NHW-ROEB-EA-NCR-323114. It has been amended to include the locations in the Atlantic Canada. If you have already submitted your application for this advertised process, you do not have to re-apply, your previously submitted application will be evaluated.

Health Canada is committed to increasing representation of Black employees and other racialized groups, Indigenous People, women and persons with disabilities. Health Canada would like its workforce to be reflective of the population it serves. Therefore, we encourage candidates to indicate voluntarily on their application if they are a member of one of these groups.

Give yourself the best chance to succeed! As the objective of this process is to assess qualifications needed for the position(s) to be staffed, let us know if you have a functional limitation/ disability, which may affect your performance. For example, contact us if you need assistance in completing and submitting your application. Should you then proceed to the next assessment stage, such as an exam or interview, we will send you an e-mail with additional information on the assessment format so that you can determine if you may require an accommodation (such as a different test format, an adaptive technology, or additional time). Assessment accommodations are designed to remove the obstacles without altering the criteria being assessed so candidates with functional limitations can fully demonstrate their abilities.

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EVERYONE IS WELCOME
Health Canada and the Public Health Agency are dedicated to building an inclusive workforce that comprises individuals who have an array of identities, abilities, background, culture, skills, perspectives, and experiences that are representative of Canada’s current and evolving population. 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.

There are two (2) Streams for this process:
Stream 1: Corporate Regulatory Compliance and Enforcement Officer
Stream 2: Regional Regulatory Compliance and Enforcement Officer

Intent of the process

This selection process may be used to fill existing and anticipatory vacancies.

A pool of qualified or partially assessed candidates will be established and may be used to staff similar positions at this group and level with various security requirements, conditions of employment as well as various tenures (acting, assignment, deployment, term and indeterminate appointment) within Health Canada across Canada.

As a result of the potential and possible use of the selection process, we encourage all employees seeking this type of position to apply.

Positions to be filled: Number to be determined

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, mechanical engineering, pharmacy, food science, or some other specialty related to the position.

NOTE: 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

All Streams:
EX1: Significant* experience responding to inquiries from internal and external stakeholders.

EX2: Significant* experience in developing two or more types of documents. Examples may include operating procedures, guidelines, action plans, briefing materials, risk communications, policy documents, regulations, reports, educational outreach material or correspondence.

*Significant is generally defined as two (2) years.

Stream 1: Corporate Regulatory Compliance and Enforcement Officer
EX3: Experience applying, interpreting and making decisions regarding regulatory requirements (for example drugs, natural health products).

Stream 2: Regional Regulatory Compliance and Enforcement Officer
EX4: Recent** and significant* experience in production, quality assurance, quality control, validation or as an auditor in the pharmaceutical industry of marketed drugs.

*Significant is generally defined as two (2) years.
** Recent is generally defined as within the last (5) years.

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

Education:

AEDU1: Graduation with a Master’s degree or PhD from a recognized post‐secondary institution with specialization in pharmacy or organic chemistry or chemical engineering or microbiology.

Degree equivalency

AEX1: Experience related to non-sterile drug manufacturing or quality assurance or quality control in compliance with established standards/regulations.
AEX2: Experience related to sterile drug manufacturing or quality assurance or quality control in compliance with established standards/regulations.
AEX3: Experience related to biotechnology drug manufacturing or quality assurance or quality control in compliance with established standards/regulations.
AEX4: Experience related to radiopharmaceutical drug manufacturing or quality assurance or quality control in compliance with established standards/regulations.
AEX5: Experience related to quality control laboratory as it relates to pharmaceutical products.
AEX6: Experience related to compliance verifications or investigations for drugs.
AEX7: Experience related to the application of Good Manufacturing Practices for natural health products.
AEX8: Experience related to the application of Good Pharmacovigilance Practices for drugs.
AEX9: Experience related to data analytics.
AEX10: Experience related to project management.

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

Various language requirements
Bilingual BBB/BBB
Bilingual CBC/CBC
English Essential

Information on language requirements

Stream 1: Corporate Regulatory Compliance and Enforcement Officer
K1: Knowledge of the Food and Drugs Act and its associated regulations regarding drugs and natural health products.

Stream 2: Regional Regulatory Compliance and Enforcement Officer
K2: Knowledge of Health Canada’s compliance and enforcement policy of health products.

Abilities:
AB1: Ability to communicate effectively orally
AB2: Ability to communicate effectively in writing
AB3: Ability to interpret and apply regulations
AB4: Ability to work under pressure and to manage competing priorities with tight deadlines

Personal Suitabilities:
PS1: Focus on Service
PS2. Effective Interpersonal Relations
PS4. Judgement
PS5: Respectful of Diversity

The following may be applied / assessed at a later date (may be needed for the job)

Operational Requirements:
Willingness to travel within and outside Canada
Willingness to work overtime evenings and weekends occasionally

Conditions of employment

Reliability Status security clearance

Fully vaccinated against COVID-19 unless accommodated due to certified medical contraindications, religion, or other prohibited grounds under the Canadian Human Rights Act.

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

Please note that your ability to communicate effectively in writing will be assessed throughout the selection process, including during the review of your curriculum vitae and answers to the questions.

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 clearly demonstrate in the screening questionnaire how they meet the education and experience criteria listed in the essential qualifications and asset qualifications, if applicable. Please note that stating that the requirement has been met, and/or listing past or current responsibilities, does not represent adequate substantiation. Rather, you must provide concrete examples that clearly illustrate how you meet the requirements by respecting the maximum number of words provided for this purpose. Resume may be used as a secondary source to validate the qualifications described; comments such as "refer to my attached resume" will not be accepted and may result in your application being rejected. Only applications submitted on-line will be accepted.

Candidates may be required to meet the asset qualifications or the organizational needs, depending on the requirements of the specific position being staffed. Meeting one or many of the asset qualifications may bea deciding factor in appointing a particular candidate amongst the qualified candidates. Please note that some or all of the asset qualifications could be used at the screening phase.

Reference checks may be sought.

An interview may be administered.

A written examination may be administered.

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

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.

Volume management strategies may be used (for example: top down approach may be used).

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.