SG-SRE-06 Regulatory Affairs Manager

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

Information you must provide:

Your résumé.

You must meet all essential qualifications in order to be appointed to the position. Other qualifications may be a deciding factor in choosing the person to be appointed. Some essential and other qualifications will be assessed through your application. It is your responsibility to provide appropriate examples that illustrate how you meet each qualification. Failing to do so could result in your application being rejected.

In order to be considered, your application must clearly explain how you meet the following (essential qualifications):
NOTE: You must provide concrete and detailed examples to clearly demonstrate how you meet the education and experience requirements listed in the essential qualifications and asset qualifications section. The screening board cannot make any assumptions about your experience. It is not sufficient to say that you have the required qualifications or to list your current duties. One effective approach would be to use the wording of each experience criterion as a heading and then write one or two paragraphs demonstrating that you have the required experience and ensure that clear and accurate details are provided. APPLICATIONS THAT DO NOT CLEARLY DEMONSTRATE THAT THE CANDIDATE MEETS THE SCREENING CRITERIA WILL (or MAY) NOT BE GIVEN FURTHER CONSIDERATION

Duties

The positions are leadership positions within the Office of Controlled Substances responsible for specific programs such as controlled drugs, exemptions, compliance, etc. Reporting to the Division Manager, the positions provide advice and support to ensure that operational and performance activities are well-managed, efficient and effective. Other responsibilities include managing teams, developing and implementing strategies and managing projects.

Intent of the process

Although the immediate intent of this Job Opportunity Advertisement is to staff on an indeterminate basis, 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, 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, mechanical engineering, pharmacy, food science, or some other specialty related to the position.

Degree equivalency

• Significant* experience leading, developing, coordinating or implementing a program, policy, process or a procedure within a regulatory environment (including but not limited to health care, food or drug inspection, pharmaceutical, legal, financial, municipal, provincial or federal governments)

• Significant* experience leading the review of new or existing standards, policies or guidelines related to regulatory activities

• Experience in providing regulatory or technical advice and recommendations to senior management**

• Experience leading multi-disciplinary teams or projects related to technical, scientific or regulatory issues

* Significant is understood to mean the depth and breadth of experience normally associated with performing a broad range of complex related activities full-time or similar functions (e.g., leading, developing, coordinating or implementing) in a wide variety of situations. This is typically associated with performing these activities for a period of approximately three years.

**Senior management means Director level and above or Canadian Forces (CF) or private sector equivalent.

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

Various language requirements
Bilingual Imperative CBC/CBC and BBB/BBB; English Essential

Information on language requirements

Knowledge:

• Knowledge of the acts and regulations that govern controlled substances in Canada.

Abilities:

• Ability to manage human and financial resources
• Ability to analyse issues and provide expert advice to senior management*
• Ability to work effectively under pressure in the face of shifting priorities and tight deadlines
• Ability to communicate effectively orally
• Ability to communicate effectively in writing

* Senior management means Director level and above or Canadian Forces (CF) or private sector equivalent.

Personal Suitability:

• Respectful of diversity
• Leadership
• Judgement
• Effective Interpersonal Relations
• Attention to Detail

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

If you possess any of the following, your application must also clearly explain how you meet it (Asset Qualifications):

• Experience managing compliance or enforcement initiatives in a regulatory program.
• Experience working in a regulatory organization with particular responsibility for compliance and enforcement.
• Experience in directing and managing the development and implementation of a quality management system, including documents and databases.
• Experience working in the pharmaceutical industry.
• Experience working as a pharmacist.

Operational Requirements:

• Willingness and ability to work overtime on short notice.
• Willingness and ability to travel on occasion.

Conditions of employment

Secret security clearance - Conditions of Employment:

• Security: Secret or Reliability depending on the position to be staffed.

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

A written examination may be administered.

An interview may be administered.

Reference checks may be sought.

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 more of the asset qualifications may be a 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 or other phase of the process.

In order to manage the number of applications in this selection process, management may use top-down, ranked experience (ie tier 3, 2, 1) or random selection at various steps in the process to determine the number of candidates who will continue in the process.

Please identify clearly your substantive group and level and your employment status on your resume and/or application form if you are already an employee of the Public Service.

Acknowledgment of receipt of applications will not be sent.

For this selection process, email is the most efficient way to communicate with you. Candidates who apply to selection processes should include an email address that accepts email from unknown users (some email systems block these types of email). It is the candidates' responsibility to inform us of a change of contact information during the course of this selection process and to regularly verify your incoming e-mails.

Please note that in addition to all assessment methods such as the application, exam, interview, correspondence and communication in relation to this selection process may also be used to assess certain qualifications.

Candidates must provide their proof of education credentials, in the form of a diploma or official transcripts (original documents only) at a later time in the process.

All the listed experiences may be confirmed when the references are taken.

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/

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.