Regulatory Affairs Specialist in Montréal, Communauté-Urbaine-de-Montréal, Québec, Canada

The incumbent provides support to the regulatory team with all submissions filed to the health authorities (e.g. FDA, Health Canada, European Medicines Agency) aligned with the regulatory strategies in support of these filings; assists with information requests for dossiers under active review; and ensures that marketing authorizations are maintained as per applicable Federal Regulations and Guidances in various jurisdictions and throughout the product(s) lifecycle.



About this role

Key Responsibilities:

Support all regulatory activities related to company product(s)

  • Manages regulatory activities to obtain and maintain Marketing Authorizations for commercial products for FDA, Health Canada, EMA and other health authority regulations as applicable
  • Assists with the compilation, writing, review and submission of dossiers to regulatory authorities and ensures documents meet applicable regulatory requirements
  • Assists to provide regulatory guidance regarding the documentation and requirements for regulatory submissions
  • Assists to provide regulatory support and expertise for early phase clinical trials; pre-IND and clinical development meetings with regulatory Agencies; and the filing of IND/NDA/BLA and related submissions to FDA, EMA, Health Canada and other health authorities as applicable
  • Provides support to various partners, CROs and US/EU Agents to support registration of Theratechnologies product(s) and Market Authorizations in other territories/ countries; and liaises with the respective Health Authorities as needed.
  • Assists with the coordination of Product Recall activities and necessary regulatory actions
  • Provides regulatory support and guidance to internal and external customers
  • Assists with/ coordinates the preparation of responses to questions and inquiries from health authorities; and subsequent follow-ups with regulatory agencies to maintain and update existing marketing authorizations
  • Analyzes product information, compiles and communicates annual notifications to Health Canada
  • Maintains current knowledge of relevant ICH, FDA, Health Canada, EMA and other health authority regulations as applicable
  • Ensures that regulatory guidance documents and regulations, as well as internal procedures are followed in order to maintain regulatory compliance
  • Assists the team with internal audits as per approved schedule, and with supplier audits
  • Performs any other related tasks as assigned by management

Execution of regulatory reviews and audits

  • Reviews and updates product labels, product monographs and labeling/packaging artwork
  • Assists with the preparation of DEL amendments, Annual Licence Renewals, Notifiable Changes, and PMPRB forms for submission to Health Canada
  • Prepares and reviews INDs, NDAs, BLAs, PSURs/PADERs, Annual Reports, and updates to Investigational Brochures to Regulatory agencies
  • Assists with internal and external audits according to the approved audit plan
  • Reviews reports and other regulatory documentation from Contractual Research Organisations (CROs)

Point of contact for regulatory documentation

  • Provides support to internal departments to ensure regulatory compliance with regulations in respect of company products
  • Produces, reviews and submits various documents/reports related to regulatory submission requirements
  • Assists with the writing of Standard Operating Procedures (SOPs) and revisions thereof and ensures their adherence


About you

Qualifications Required

  • University degree in a scientific field (e.g. B.Sc. in Life Sciences) or other scientific background that is deemed appropriate
  • 3-5 years experience in the pharmaceutical industry, specifically in regulatory affairs in pharmaceutical drugs and /or biologics
  • Regulatory affairs experience in Oncology is an asset and/or other therapeutic areas
  • Good understanding of, or experience in laboratory research, preclinical and clinical research is an asset
  • Prior experience in regulatory audits is an asset
  • Experience of managing external partners/CROs is an asset
  • Excellent knowledge and comprehension of Canadian and US Regulations; good knowledge of European regulations is an asset
  • Good knowledge of Word, Excel, Power Point and Outlook
  • Ability to conduct Internet searches in respect of regulatory matters
  • Bilingual in French and English, oral and written

Personal Qualities for all Staff

  • Ability to set goals and meet deadlines
  • Ability to prioritize
  • Ability to generate ideas and find solutions
  • Ability to work independently
  • Able to work well in a team environment and communicate well
  • Versatility and flexibility

Personal Qualities Specific to Position

  • Interpersonal ability and diplomacy
  • Attention to detail and quality
  • Good stress management
  • Ability to influence others
  • Multi-tasking
  • Interpersonal leadership
  • Planning and organizational skills
  • Available for occasional business travel


What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort let us match you to your ideal position.




About us

Brunel has a reputation for working with some of the best in the business. Thats what we continually strive for. Over 40 years, weve created a global network of interesting clients and talented individuals working together through a vast array of services.

JOB SEARCH

Keywords / job title / skill / company

Type any location in the box above, or select below :
Africa
Asia & Pacific
CIS
Europe
Middle East
North America
South America
Afghanistan
Åland Islands
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas, The
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
British Virgin Islands
Brunei
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo, Democratic Republic of the
Congo, Republic of the
Cook Islands
Costa Rica
Cote d'Ivoire
Croatia
Curaçao
Cyprus
Czech Republic
Denmark
Djibouti
Dominica
Dominican Republic
East Timor
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands (Islas Malvinas)
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern and Antarctic Lands
Gabon
Gambia, The
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See (Vatican City)
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea, South
Kosovo
Kuwait
Kyrgyzstan
Laos
Latvia
Lebanon
Lesotho
Liberia
Libyan Arab
Liechtenstein
Lithuania
Luxembourg
Macau
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia, Federated States of
Moldova, Republic of
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
Netherlands Antilles
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian territories
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn Islands
Poland
Portugal
Puerto Rico
Qatar
Reunion
Romania
Russia
Rwanda
Saint Barthélemy
Saint Helena
Saint Kitts and Nevis
Saint Lucia
Saint Martin
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and the Islands
South Sudan
Spain
Sri Lanka
Suriname
Svalbard
Swaziland
Sweden
Switzerland
Taiwan
Tajikistan
Tanzania, United Republic of
Thailand
The Former Yugoslav Republic of Macedonia
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
United Arab Emirates
United Kingdom
United States
United States Minor Outlying Islands
Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
Virgin Islands (US)
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe

Country, town, city or postcode

--Web2New--