Regulatory Affairs Specialist

1 week ago

Toronto, Canada Mundipharma Full time

Job Title: Regulatory Affairs Specialist

Department: Scientific Affairs

Reports To (Title): Regulatory Affairs Manager/Senior Manager

Job PurposeBroadly describe the main purpose of the job. Indicate what the job does and why (the outcome).

The primary objective of this position is to compile and revise Regulatory documents and submissions that are accurate, complete, and in compliance with federal regulatory requirements. This role assists with development of timely Formulary strategies and analyses for new products and continued reimbursement of Purdue Pharma products. Maintains up-to-date knowledge of local regulatory requirements and local and global company processes. Lead and support initiatives and systems for electronic submissions and data storage. Works under general supervision.

Key ResponsibilitiesThe table below details the 4 to 5 key responsibilities of the job. These responsibilities represent the major areas of work performed and are not an exhaustive list of all tasks. Please list responsibilities in order of frequency, starting with the responsibility that requires the most amount of time.

Key Responsibility

1

In association with Regulatory Affairs Manager, develops Federal drug submissions, including S/NDSs, N/Cs, DIN, NHP submissions, including obtaining, assessing and summarizing clinical and other technical information and developing rationales to support claims.
- Populates Health Canada templates
- Organizes and prepare sectional reports and complete administration sections (i.e., Part 1 and 5 of NDS) of submission for review
- Submissions are developed with respect to chemistry, manufacturing and clinical data
- Submissions meet administration, structural and technical requirements as evidenced by absence of screening deficiencies or review deficiencies in these areas
- Disposition of submissions within current performance standards of the responsible TPD unit
- Manage interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval and optimal labelling
- Review Change Controls and determine filing/notification requirements
- Collaborate with local and global partners to ensure alignment of regulatory affairs strategy with business priorities, objectives and timelines

2

Lead and support the management of electronic regulatory documentation and submissions and archive systems for effective utilization by the department
- Manages and structures electronic file transfers
- Maintains and develops submission templates
- Maintain electronic files on local servers
- Files are readily retrievable and contain accurate and current information

4

Labelling Compliance
- Prepare Product Monograph updates for labelling compliance with CCDS.
- Submit updated Prescribing Information to eCPS and send updates to Library Services to post on the company website.
- Prepare Marketing versions of TPD approved Product Monographs and distribute as necessary (logistics, Marketing)
- Provide applicable Global Safety Leader and local Pharmacovigilance lead with information required for the compilation of global PSURs.
- Review of promotional material for Rx and Consumer Health Products (OTC, NHPs)

QualificationsThe table below details the minimum levels of education and experience, as well as the minimum and preferred qualifications, certifications or designations required to complete the job.

Minimum Required:
Preferred:
Education

Life Sciences College or University Degree or equivalent

Certifications or Designations

Regulatory Affairs Certification

Experience

Pharmaceutical or Consumer Health product Regulatory Affairs experience

Knowledge and Skills
- Understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Acts and Regulations and knowledge of submission content and format.
- Understanding of drug development process, including chemistry and drug manufacturing.
- Ability to understand and summarize large amounts of complex data, for the purpose of generating drug submissions. Excellent organizational skills for development of complex documents are required.
- Fluency in French would be an asset.

Communication & Working RelationshipsList the key contacts that the job is responsible for communicating with on a regular and on-going basis, an example of the typical communication, and whether the contact is internal or external.

Contact

Example

Internal / External

Health Canada

NDS, SNDS or Annual Notification submissions

External

Global Regulatory Leads

All regulatory submissions e.g. NDS, compliance submissions, PSUR/PBRER submissions

Internal

Quality

CMC changes

Internal

Marketing

Changes in mock labeling

Internal

Supply Chain

Product Monograph updates

Internal

RS consultants and Publisher

Intrinsic for submission publishing to eCTD gateway

External

Central regulatory vendors

Syneos Health

External

Reporting RelationshipsThe table below details the number of direct reports supervised

  • Regulatory Affairs Specialist Ii

    4 days ago

    Toronto, Canada Boston Scientific Corporation Full time

    **Regulatory Affairs Specialist II**: - Remote Eligible: Hybrid- Onsite Location(s): Toronto, CA**Purpose and Passion - Comprehensive Benefits - Life-Work Integration - Community - Career Growth** At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With...

  • Principal Compliance Specialist, Regulatory Affairs

    5 days ago

    Toronto, Canada Capital One Full time

    161 Bay Street (93021), Canada, Toronto,Toronto, Ontario, Principal Compliance Specialist, Regulatory Affairs **Principal Compliance Specialist, Regulatory Affairs Office, Canada Compliance** **Our Capital One Compliance** **Team.** Yes, we’re a credit card company. But we’re more than that too. We’re driven by what our customers want, and how to...

  • Regulatory Affairs Specialist

    Found in: Talent CA C2 - 3 weeks ago

    Toronto, Canada LEO Pharma Full time

    Role Description Overall Objective:   Contribute to, and/or manage, the preparation and regulatory review of filings to Health Canada for both new and existing drug products. This includes the preparation of New Drug Submissions, Supplemental New Dug Submissions, Notifiable Changes, Annual Drug Notifications, and Clinical Trial...

  • Regulatory Affairs Specialist Iii

    5 days ago

    Toronto, Canada Zany Consulting Group Full time

    The Regulatory Affairs CMC Manager is supporting the regulatory submission activities of the Canadian Regulatory Affairs CMC group for vaccines. **Responsibilities**: - Develops submission strategy and is responsible for managing all the regulatory CMC aspects throughout the life cycle of the assigned product/project. - Authors the CMC sections (Modules...

  • Regulatory Affairs Manager

    6 days ago

    Toronto, Canada Advanced Clinical Full time

    Regulatory Affairs Manager **Location**: Toronto, ON, Canada **Requisition Number**463** **Remote** Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research -...

  • Regulatory Affairs Associate

    2 weeks ago

    Toronto, Canada Jamieson Wellness Inc. Full time

    Overall Responsibilities Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    2 weeks ago

    Toronto, Canada Jamieson Wellness Inc. Full time

    Overall Responsibilities Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    2 weeks ago

    Toronto, Canada Jamieson Wellness Inc. Full time

    Overall Responsibilities Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    2 weeks ago

    Toronto, Canada Jamieson Wellness Inc. Full time

    Overall Responsibilities Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    1 day ago

    Toronto, Canada Jamieson Wellness Inc. Full time

    Overall Responsibilities Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    1 day ago

    Toronto, Canada Jamieson Wellness Inc. Full time

    Overall Responsibilities Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Manager, Regulatory Affairs

    2 weeks ago

    Toronto, Canada Options Consulting Solutions Full time

    MANAGER, REGULATORY AFFAIRS FULL-TIME OTTAWA OR TORONTOAre you in expert in health products regulations and submissions?The Company Our client is a national trade association renowned for the fantastic everyday products they offer. They are looking for an expert in regulatory affairs with a learning mindset and determination to be a top contributor to take...

  • Manager, Regulatory Affairs

    2 weeks ago

    Toronto, Canada Options Consulting Solutions Full time

    MANAGER, REGULATORY AFFAIRS FULL-TIME OTTAWA OR TORONTO Are you in expert in health products regulations and submissions? The Company Our client is a national trade association renowned for the fantastic everyday products they offer. They are looking for an expert in regulatory affairs with a learning mindset and determination to be a top contributor to...

  • Regulatory Affairs Associate

    2 days ago

    Toronto, Canada Jamieson Wellness Inc. Full time

    Overall Responsibilities Reporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Manager

    16 hours ago

    Toronto, Canada Pharma People Full time

    Role Overview:This position entails overseeing project management within Regulatory Affairs for both emerging and established products.Responsibilities:- Provide strategic and operational regulatory guidance to teams locally and globally across product lifecycles.- Develop and implement filing strategies, evaluating scientific and clinical data as needed.-...

  • Regulatory Affairs Officer.

    Found in: Talent CA C2 - 2 weeks ago

    Toronto, Canada PSI Full time

    Job Description Join our team of experts in regulatory and ethics submissions of clinical studies! You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. This is a hybrid role which includes remote and in-office work.  Your role: Responsible for...

  • Regulatory Affairs Manager

    15 hours ago

    Toronto, Canada Pharma People Full time

    Role Overview: This position entails overseeing project management within Regulatory Affairs for both emerging and established products. Responsibilities: - Provide strategic and operational regulatory guidance to teams locally and globally across product lifecycles. - Develop and implement filing strategies, evaluating scientific and clinical data as...

  • Regulatory Affairs Manager

    18 hours ago

    Toronto, Canada Pharma People Full time

    Role Overview: This position entails overseeing project management within Regulatory Affairs for both emerging and established products. Responsibilities: - Provide strategic and operational regulatory guidance to teams locally and globally across product lifecycles. - Develop and implement filing strategies, evaluating scientific and clinical data as...

  • Regulatory Affairs Manager

    13 hours ago

    Toronto, Canada Pharma People Full time

    Role Overview: This position entails overseeing project management within Regulatory Affairs for both emerging and established products. Responsibilities: - Provide strategic and operational regulatory guidance to teams locally and globally across product lifecycles. - Develop and implement filing strategies, evaluating scientific and clinical data as...

  • Regulatory Affairs Manager

    5 hours ago

    Toronto, Canada Pharma People Full time

    Role Overview:This position entails overseeing project management within Regulatory Affairs for both emerging and established products.Responsibilities: - Provide strategic and operational regulatory guidance to teams locally and globally across product lifecycles. - Develop and implement filing strategies, evaluating scientific and clinical data as...