Competency Profile

Regulatory-Affairs Specialist
Reports to: Director or Manager

Main • P
 articipates in the development and
Evolution • T
 he duties and responsibilities of

Duties implementation of the regulatory strategy:

compiles information and data pertaining to regulatory of the
Regulatory-Affairs Specialists have
expanded as a result of company
may vary from
and project requirements; assesses needs; identifies acquisitions and restructuring,
one company
to another
the project’s critical factors; presents decision-makers Profession
La Commission des partenaires du marché du travail contribue
worldwide globalization of markets,
with options; applies strategies. and ever-evolving regulations.
au financement des activités de Pharmabio Développement.

• Assembles a regulatory file/dossier: coordinates • T

 he office of regulatory affairs is
a cquisition of all applicable data; assessed data; drafts and submits considered one of a company’s
the regulatory file. strategic pillars. The operations in support of the strategic
aspects include file preparation, information management,
• M
 onitors product files in the developmental phase: updates data; file maintenance, and interaction with different departments.
reconciles requests from authorities based on scientific and ethical The guiding principle is to strike a balance between
constraints; makes amendments/changes and submits them to authorities. regulatory concerns, technology, marketing objectives,
time to market, and costs.
• C
 onducts regulatory monitoring of approved products: assists
and supports in-house teams; maintains files current; ensures regulatory • T
 he office of regulatory affairs is an extremely dynamic
compliance; evaluates the effects of an amendment/change; takes work environment where communication with employees at
appropriate regulatory actions. all levels within the organization is of paramount importance.

• P
 rovides counselling to internal and external clients with regulatory
issues: ensures regulatory monitoring; formulates a regulatory opinion;
supports employees and the management team; represents the company;
conveys information about regulatory matters and their application.
• U
 pgrade knowledge in order to
Best remain effective in the profession.

Main responsibilities 1 Practices • A

 ttend conferences as well
as continuing-education and
development activities.
Participation in the Preparation, Submission, and Follow-up
Development and Implementation of a Regulatory File • Regulatory-Affairs Specialists
of Regulatory Strategy • Properly documents all file data. are required to undergo training on all direct and indirect
• Correctly compiles applicable • Diligently verifies that collected data aspects of drug development: good clinical practices,
guidelines for the project. comply with the regulations in effect. good laboratory practices, good manufacturing practices,
• Realistically defines the project profile. • Accurately analyzes and verifies regulations (Canada, United States, Europe, etc.), and
• Consults external authorities in order file contents. management. Introductory courses in other areas — such
to confirm the strategy. • Conducts proper assessments as law, marketing, statistics, pharmacology, toxicology,
• Accurately identifies short- and in order to anticipate questions communications and interpersonal relationships — are
long-term needs. and critical issues. also recommended, as are a second language and
• Ensures the high quality of • Updates preclinical, clinical software proficiency.
written materials. (efficacy and safety), and CMC
• Scrupulously analyzes risks. (chemical-manufacturing control) data.
• Formulates an organized contingency • Clearly responds to questions from
plan based on the project’s critical regulatory authorities. Regulatory Monitoring of an Approved Product
factors and a risk-mitigation plan. • Justifies position (legal, ethical, • Revises and approves the information in the product
• Specifies the different project phases or scientific) when there are differences monograph, label, and finished-product documentation.
and the corresponding deadlines. of opinion in connection with a request • Actively involved in reviewing promotional materials
• Provides suitable support to from regulatory authorities. for compliance.
stakeholders in implementing • Regularly monitors commitments/obligations • Maintains drug identification number (DIN) and other licences.
the strategy. in response to regulatory requirements • Properly prepares and submits annual notification of changes.
• Respects timelines. or requests. • Collects data and diligently analyzes the effects of a change.
• Submits documentation to concerned • Properly notifies authorities about changes and their
authorities within prescribed timelines. implementation.
• Properly manages post-approval commitment plans.

1 As per the company’s mode of operations.

 Regulatory-Affairs Specialists have:
• A university degree in science (bachelor’s, D.É.S.S. [Diplôme d’Études Supérieures Career-Path
Qualifications Spécialisées]), master’s, doctorate) biology, chemistry, biochemistry, toxicology,
pharmacy, pharmacology, or a related discipline. Options
• T
 wo to five years of relevant experience in research, laboratory testing, manufacturing
procedures, or clinical trials.

Employers are looking for candidates who possess, among other skills, the following: With experience, depending
• Autonomy and leadership. on interests and training,
• Ability to communicate effectively, negotiate, and persuade. Regulatory-Affairs Specialists
• Ability to work on multiple projects at the same time. can aspire to, among other
• Ability to keep tight deadlines and work under pressure. positions, the following:
• Flexibility and ability to adapt to change. • Project Leader.
• Sound judgment in applying regulatory requirements. • Director.
• Diplomacy and ease in establishing and maintaining interpersonal relationships. • Consultant.
• Strategic thinking as well as analytical and synthesis skills. • Regulatory-Agency Inspector.
• Fluency in French and English (written and spoken). • Trainer or Educator.
• Scientific rigour, attention to detail, meticulousness.
• Organizational skills and structured work habits.

Competencies Behavioral Indicators

Leadership • Evaluates the facts in order to make the best decisions.

Ability to influence achievement • Is able to negotiate and persuade.
of strategic objectives. • Ensures proactive management of the company’s response and commitment
in dealings with authorities.
• Makes realistic and appropriate decisions within a regulatory context.

Communication and • C ommunicates clearly and effectively within all levels of the organization
Interpersonal Skills and with external resources.
Ability to build relationships of trust • Acts as liaison between authorities as well as outside partners and clients
and demonstrate professional ethics. in order to provide adequate regulatory direction to in-house resources.
• Develops effective working relationships.
• Takes patient safety into account in all required regulatory actions.
• Drafts reports within prescribed time lines in accordance with regulations.

Problem Solving • A
 dopts an innovative and rigorous approach to problem solving within
Ability to implement solutions in response a regulatory context.
to regulatory changes. • Assesses the urgency of situations.
• Proposes relevant solutions to achieve objectives.

Advisory Role • Offers a strategic opinion compliant with the requirements of authorities.
Ability to support employees from • Offers sound advice and assists managers in strategy development.
different company departments • Performs monitoring activities and provides appropriate support
and outside resources. to concerned resources.
• Ensures that representatives of regulatory agencies are apprised of innovative
drugs and new technologies.
• Makes a positive contribution during representations.

Please refer to the Regulatory-Affairs Specialist’s Analyse de profession* and Profil de compétences* for all additional information.
The Competency Profile was made through funding by the Commission des partenaires du marché du travail.
* This document has not been translated yet.