Stream 1: Regulatory Affairs/Regulatory Project Management; Stream 2: Labelling (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

***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 PRE-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.

Stream 1: Regulatory Affairs/Regulatory Project Management
Stream 2: Labelling

PLEASE NOTE THAT YOUR RESPONSES TO THE PRE-SCREENING QUESTIONS AND YOUR RESUME WILL EVALUATE YOUR ABILITY TO COMMUNICATE EFFECTIVELY IN WRITING.

Intent of the process

A pool of qualified or partially assessed candidates may be created to staff similar positions within Health Canada at this group and level with various linguistic requirements, various security requirements, various conditions of employment as well as various tenures as mentioned above. As a result of the potential and possible use of the selection process and subsequent pool by hiring managers, we encourage all seeking this type of position and/or group and level 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)

Essential Criteria

Education:

All Streams
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

Experience:

All Streams
EE1. Experience in providing regulatory advice to internal and external stakeholders based on the interpretation of operating procedures, policies, guidelines or legislation.
EE2. Experience in contributing to the development, revision and/or implementation of standards, policies, guidelines, processes or systems related to regulatory activities.
EE3. Experience in leading or contributing to regulatory working groups, committees or project teams established to provide advice and recommendations on regulatory issues.

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

Asset Qualifications

Education

All Streams
AE1. Post-graduate diploma or certificate in Regulatory Affairs from a recognized university college, university, or certification body.
AE2. Postgraduate degree from a recognized university in a field of science such as microbiology, biochemistry, pharmacology, pharmacy, pharmaceutical or medical sciences, human biology, biotechnology, immunology, nursing or some other specialty related to the position.

Degree equivalency

Experience:

All Streams
Experience working as a health care professional (e.g. as a pharmacist or nurse) or in the pharmaceutical industry.

Stream 2: Labelling
Experience in providing advice and guidance related to the Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs.
Experience in reviewing drug submissions subject to the plain language labelling requirements of therapeutic drug products for human use.

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

Various language requirements
English Essential
Bilingual Imperative (BBB/BBB)

Information on language requirements

Knowledge:

All Streams
EK1. Knowledge of the Food and Drugs Act and its Regulations and related guidelines governing the therapeutic drug product review process in Canada.

Abilities:
All streams
EA1. Ability to analyse problems involving ambiguity, multiple perspectives, and/or different disciplines, to provide advice and recommend solutions
EA2. Ability to coordinate multiple projects under tight timelines efficiently and effectively.
EA3. Ability to communicate effectively orally.
EA4. Ability to communicate effectively in writing

Stream 2: Labelling
EA5. Ability to provide advice and make recommendations on the labelling of pharmaceutical drugs for human use, based on the interpretation of the Food and Drugs Act and its related Regulations, and relevant guidelines.

Personal Suitabilities:

All Streams
EPS1. Respectful of Diversity
EPS2. Judgment
EPS3. Thoroughness
EPS4. Initiative
EPS5. Reliability
EPS6. Effective Interpersonal Relations

Conditions of employment

Reliability Status security clearance

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 ensure you read all poster notes thoroughly as they contain important information that will be required in the application process. Failure to read the notes and follow the instructions could result in your application missing critical information and having insufficient information for the assessment board to complete your assessment resulting in your elimination from the process.

A written examination may be administered.

Reference checks may be sought.

An interview may be administered.

**To be able to manage the number of applications in this appointment process, management may choose to use one or more Asset Qualifications at the pre-screening stage to determine the number of applicants who will advance to the following stage**.

Candidates whose substantive position is the same group and level or equivalent to the position being staffed may be considered for a deployment.

In the case of an acting appointment, the Public Service Employment Regulations enables the organization to exclude the appointee from respecting official language proficiency when the department is unable to fill the position with an appointment of a person who meets the language proficiency qualification. Therefore, we would encourage all to apply, in the event the organization is unable to fill the position with an appointment of a person who meets the language proficiency, others may be considered.

An assignment/acting appointment is a temporary resourcing option. The approval of your substantive supervisor may/will be required before an offer can be made.

Please identify clearly your substantive group and level and your employment status on your resume and/or application form.

Please ensure that your Personal Record Identifier (PRI) is included in your application.

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.

CANDIDATES WILL NOT BE SOLICITED FOR INCOMPLETE OR POSSIBLY MISSING INFORMATION.

For this process, emails are the most efficient way to communicate with you. CANDIDATES WHO APPLY TO THIS SELECTION PROCESS MUST INCLUDE AN EMAIL ADDRESS THAT ACCEPTS EMAIL FROM UNKNOWN USERS (SOME EMAIL SYSTEMS BLOCK THESE TYPES OF EMAIL). If you do not wish to receive results by email and if you change your email address during the process, it is your responsibility to inform us.

You must provide proof of education credentials at a later time in the process. Candidates with foreign credentials must provide proof of Canadian equivalency. Consult the Canadian Information Centre for International Credentials for further information at http://www.cicic.ca/indexe.stm

Candidates must meet the essential qualifications to be appointed to a position. 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 be a deciding factor in appointing a particular candidate amongst the qualified candidates. Please note that one, some or all of the asset qualifications could be used at the screening phase.

As an equal opportunity employer, the Public Service of Canada is committed to accommodating the needs of persons with disabilities. If you have any health or physical limitations, which may adversely affect your performance during any phase of the appointment process, please identify any accommodation needed.

LEAVE/ABSENCES DURING THIS SELECTION PROCESS: It is the responsibility of the candidate to notify the responsible manager of the process of any pre-approved leave throughout the duration of the process in order to facilitate scheduling of evaluations. An alternate date may be possible if requested for valid reasons, subject to the approval of the selection committee.

Preference

Preference will be given to veterans and to Canadian citizens, in that order, 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.