Regulatory Affairs, Senior Associate

4 weeks ago

Kingston Nova Scotia BP, Simonds, Canada Rossi Recruitment Full time

July 30, 2024

Job Summary

We are currently seeking a self-motivated individual to join the Regulatory Affairs team. The successful candidate will be a critical team member responsible for preparation and submission of various regulatory submissions (primarily CMC documents) for new or marketed generic products to Health Canada or external stakeholders. This position offers a great opportunity for professional development with a rapidly growing Canadian company.

Job Specifications

Roles and Responsibilities:

  1. Prepare and submit various regulatory submissions in the CTD format to Health Canada.
  2. Ensure that submissions are accurate, complete, and compliant with regulatory requirements.
  3. Create, review, and maintain documents and standards within Regulatory Affairs.
  4. Perform regulatory risk assessment by identifying, describing, and estimating the risks affecting current and future development projects.
  5. Prepare responses to questions raised by Regulatory Authorities or business partners in a timely manner and within deadlines.
  6. Perform gap analysis on dossiers to identify weaknesses for ANDS submission to Health Canada.
  7. Communicate and coordinate with partners/manufacturers to obtain supporting documents for ANDS submission.
  8. Assess, coordinate, and compile deficiency responses in a timely manner to deficiency questions from Health Canada.
  9. Prepare product labelling and monographs, as well as related items.
  10. Support internal and external groups to assist with product listing on all the provincial formularies.
  11. Responsible for post-market product administration, participating in the review and evaluation of planned changes for impact on regulatory submissions, identifying regulatory filing requirements, and recommending regulatory agency and customer notification strategies/plans in the affected regulatory jurisdictions.
  12. Evaluate proposed changes to development and marketed products for regulatory impact and liaise with internal/external stakeholders to assemble necessary documentation.
  13. Assist in developing and maintaining various regulatory tracking tools.
  14. Work closely with all functional groups (Business Development, Legal, Production, Quality, R&D) within and outside (manufacturing partners) the company to ensure all regulatory obligations are met.
  15. Manage collaborations with external partner sites for new projects and serve as the main point of contact with third-party manufacturers for the projects led.
  16. Maintain awareness of current regulatory environment and guidelines that impact the organization and share knowledge with internal stakeholders, as required.
  17. Support implementation of QA systems and generation of Standard Operating Procedures.
  18. Remain up to date on applicable regulatory guidelines (Health Canada, ICH, etc.).
  19. Perform other duties as required or necessary.

Any other duties as assigned by Senior Scientific Affairs Leadership team.

Major Tasks:

Submissions

  1. Review dossiers shared by partner companies for regulatory submissions for completeness, accuracy, and compliance with regulatory requirements and provide feedback to partners.
  2. Review Drug Master Files and provide gap assessments to partners.
  3. Prepare regulatory submissions (CTD format) including compiling, writing, and publishing.
  4. Negotiate with regulatory authorities to gain approval (NOC) and obtain alignment from partners and other functional groups on responses.
  5. Timely preparation and filing of submissions to support company needs.
  6. Supervise and coordinate with outside consultants and subject matter experts relating to the preparation of regulatory submissions and other related regulatory activities, as required.

New Product Assessments/ Product Launches

  1. Monitor product development activities by interacting with contract manufacturers as necessary against identified submission targets.
  2. Provide impact regarding formulation of drug development, clinical development, etc. Initiate Change Controls for changes from submission documents to launch documents, for handover to Quality Department.

Labelling

  1. Review and approve artwork routings of labelling.

Compliance

  1. Ensure continual regulatory compliance of all products due to changes initiated from Health Canada (e.g., Labeling, Quality, changes).
  2. Help to develop and oversee procedures and processes within Regulatory Operating Procedures to ensure compliance with applicable regulations (e.g., Working Instructions are up to date, SOPs are followed, etc.).
  3. Assist in development and maintenance of accurate databases.
  4. Oversee the timely preparation of activities for other functional groups (SAP codes creations, launch documentation packages).
Qualifications
  1. Bachelor of Science (or higher) in Biological Sciences, Pharmacology, Toxicology, Chemistry, or related Health Sciences.
  2. Must have strong technical knowledge of CMC requirements and be able to critically analyze scientific data.
  3. Strong knowledge of CTD requirements for drug submissions.
  4. Knowledge of electronic submissions, including e-publishing (e.g., Docubridge).
  5. Strong interpersonal skills and ability to foster strong working relationships with key stakeholders (internally and externally).
  6. Strong working knowledge of Canadian Food and Drugs Act and Food and Drug Regulations, GMPs, ICH Guidelines, and Health Canada Policies and Guidelines.
  7. Ability to prioritize workload to ensure all deadlines are met.
  8. Excellent organization, written, and oral communication skills.
  9. Ability to effectively manage multiple projects in a fast-paced, results-oriented environment.
  10. Strong commitment to quality, accuracy, and detail.
  11. Ability to work well under pressure in a team-based environment.
Apply Now

Your first name

Your phone number

Which job position are you applying for?

Would you like to sign up for our newsletter to keep up to date?
Yes, Please send me updates.

#J-18808-Ljbffr

  • Senior Regulatory Specialist

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Embassy Ingredients Full time

    Are you an expert in quality, compliance, and food safety ready to make a meaningful impact and grow in a dynamic environment? Embassy Ingredients is seeking a motivated individual to join our team as a Senior Regulatory Specialist. In this role, you will be at the forefront of ensuring our products uphold the highest legal, regulatory, and certification...

  • Senior Regulatory Specialist

    4 weeks ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Embassy Ingredients Full time

    Are you an expert in quality, compliance, and food safety ready to make a meaningful impact and grow in a dynamic environment? Embassy Ingredients is seeking a motivated individual to join our team as a Senior Regulatory Specialist. In this role, you will be at the forefront of ensuring our products uphold the highest legal, regulatory, and certification...

  • Senior Director, Quality Assurance Programs and Compliance

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Accoravillage Full time

    Senior Director, Quality Assurance Programs and Compliance Tuesday, July 23, 2024 Position Summary: Reporting to the Chief Safety Officer, the Senior Director, Quality Assurance (Programs & Compliance) will, in collaboration with Operations and the Quality team, manage, guide, the quality, food safety and regulatory requirements and compliance for all...

  • Manager, Compliance Business Oversight

    4 weeks ago

    Kingston, Nova Scotia, B0P, Simonds, Canada TD Bank Full time

    Work Location:Toronto, Ontario, CanadaHours:37.5Line of Business:CompliancePay Details:We're committed to providing fair and equitable compensation to all our colleagues. As a candidate, we encourage you to have an open dialogue with a member of our HR Team and ask compensation related questions, including pay details for this role.Job...

  • Associate actuary

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Société Financière Manuvie Full time

    Nous sommes un fournisseur de services financiers qui s’emploie à faciliter les décisions de nos clients et de nos collègues partout dans le monde et à les aider à vivre mieux. De nos initiatives environnementales à nos investissements dans la collectivité, nous montrons la voie en nous appuyant sur des valeurs, et ce, dans l’ensemble de nos...

  • Treasury associate program

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada TD Full time

    Type de rôle: Masters and Advanced DegreesSession de stage:Lieu de travail: CanadaHoraire: 37.5Détails de la rémunération:Nous avons à cœur d’offrir une rémunération juste et équitable à tous nos collègues. En votre qualité de candidat ou de candidate, nous vous encourageons à avoir une conversation franche avec votre recruteur et à poser des...

  • Analyste princ., gestion des affaires

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada TD Full time

    Lieu de travail:CanadaHoraire:37.5Secteur d’activité:Gestion des affaires, Stratégie et soutienDétails de la rémunération :Nous avons à cœur d’offrir une rémunération juste et équitable à tous nos collègues. En votre qualité de candidat ou de candidate, nous vous encourageons à avoir une conversation franche avec votre recruteur et à poser...

  • Audit Manager, AML/ATF

    4 weeks ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Scotiabank Full time

    Requisition ID: 203594Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. Purpose The Audit Department is the 3rd line of defense and plays a key role in the internal control system of the Bank. Its mandate is to provide independent and objective assurance over the design and effectiveness of internal...

  • Senior Accountant, Finance

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Brookfield Asset Management Full time

    LocationBrookfield Place - 181 Bay StreetBrookfield CultureBrookfield has a unique and dynamic culture. We seek team members who have a long-term focus and whose values align with our Attributes of a Brookfield Leader: Entrepreneurial, Collaborative and Disciplined. Brookfield is committed to the development of our people through challenging work assignments...

  • Analyste princ., trésorerie

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada TD Full time

    Lieu de travail: CanadaHoraire: 37.5Secteur d’activité: FinancesDétails de la rémunération : Nous avons à cœur d’offrir une rémunération juste et équitable à tous nos collègues. En votre qualité de candidat ou de candidate, nous vous encourageons à avoir une conversation franche avec votre recruteur et à poser des questions sur la...

  • Senior Manager, Strategic Sourcing, SSEVM

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Scotiabank Full time

    Requisition ID: 203951Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture.The Senior Manager, Strategic Sourcing, SSEVM is responsible for leading Bank-wide sourcing and project activities while working closely with senior business unit leadership and other sourcing leaders. The Senior Manager will have the...

  • Senior Analyst, TM Compliance

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Exchange Bank of Canada Full time

    Exchange Bank of Canada (EBC) is a Schedule 1 bank headquartered in Toronto, Canada.Discover the opportunity to join an international, dynamic, and responsible bank that fosters the development of all its employees. Every day, we empower employees to achieve more. As we are a new bank in Canada, each employee is given a unique experience and great...

  • Senior Associate

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Farnham Accountants & Advisors Full time

    WHAT EXCITES YOUAre you a versatile professional with a thirst for variety and a knack for client service? Are you hoping to build on your accounting and advisory background as part of a team of enthusiastic and dedicated professionals? Are you passionate about helping entrepreneurs? If your answer is YES!!! to all of the above, you might just be the...

  • Senior Manager Market Access

    4 weeks ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Sun Pharmaceutical Industries, Inc. Full time

    This individual must have a passion for patient access to innovative medicines across Canada and collaborating with a high-performance team that delivers exceptional results. This individual should be focused on making innovative contributions to the organization, have a positive outlook on change, and be adaptable to a dynamic environment without losing...

  • Bilingual Senior Quality Assurance Specialist, Personal Lines

    4 weeks ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Echelon 56 Full time

    Bilingual Senior Quality Assurance Specialist, Personal LinesEchelon Insurance provides Personal and Commercial Specialty Insurance solutions to protect Canadian families and businesses across Canada, through our trusted network of Broker partners. Echelon is a member of the CAA Club Group of Companies and is an equal opportunity employer that offers a...

  • Senior specialist, quality assurance

    4 weeks ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Loblaw Companies Ltd - Head Office Full time

    Les candidats référés ne doivent pas postuler directement pour ce poste.Toutes les références de candidats doivent d’abord être soumises dans Workday par un collègue de Loblaw actuel.L’utilisation du masculin à pour but d’alléger le texte.Venez faire votre différence dans les communautés à travers le Canada, où l'authenticité, la...

  • Senior compliance business oversight

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada TD Full time

    Lieu de travail:CanadaHoraire:37.5Secteur d’activité:ConformitéDétails de la rémunération :Nous avons à cœur d’offrir une rémunération juste et équitable à tous nos collègues. En votre qualité de candidat ou de candidate, nous vous encourageons à avoir une conversation franche avec votre recruteur et à poser des questions sur la...

  • ScotiaMcLeod Senior Financial Planning Associate

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada Scotiabank Full time

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Requisition ID: 200712As a cornerstone business within Scotia Wealth Management, ScotiaMcLeod has earned a reputation for integrity based on service excellence and trusted investment advice. Our advisors and teams pride themselves on exploring innovative approaches...

  • Senior analyst, compliance governance

    1 month ago

    Kingston, Nova Scotia, B0P, Simonds, Canada TD Full time

    Lieu de travail:CanadaHoraire:37.5Secteur d’activité:ConformitéDétails de la rémunération :Nous avons à cœur d’offrir une rémunération juste et équitable à tous nos collègues. En votre qualité de candidat ou de candidate, nous vous encourageons à avoir une conversation franche avec votre recruteur et à poser des questions sur la...

  • Senior tds operations associate

    4 weeks ago

    Kingston, Nova Scotia, B0P, Simonds, Canada TD Full time

    Lieu de travail:Toronto, Ontario, CanadaHoraire:37.5Secteur d’activité:Valeurs Mobilières TDDétails de la rémunération :Nous avons à cœur d’offrir une rémunération juste et équitable à tous nos collègues. En votre qualité de candidat ou de candidate, nous vous encourageons à avoir une conversation franche avec votre recruteur et à poser...