Regulatory Affairs Specialist

2 days ago

Toronto, Canada Raise Full time

Regulatory Affairs Specialist II (Clinical)

Location: Toronto, ON (Hybrid)

Contract Length: 12 Months


We at Raise are hiring a Regulatory Affairs Specialist II (Clinical) for one of our top clients. After establishing themselves as an industry leader, they’re now expanding their team to meet rising demand.


Responsibilities:

  • Supports batch release by following submission and approval to ensure the product regulatory compliance on his/her sites(s).
  • Ensures that the CMC dossier is in line with manufacturing and control procedures on site(s) and with dossiers approved by Health Authorities.
  • Review cGMP documents such as Master Specification documents.
  • Maintain the site’s Drug Establishment License.
  • Change Control
  • Provides regulatory expertise to site projects.
  • Evaluate the potential regulatory impact of the site’s change controls including supplier change notifications.
  • CMC Documentation management
  • Writes CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submission (CMC portions of Module 1, Module 2.3 and Module 3).
  • Coordinates CMC writing performed by another entity (internal or external).
  • Optimizes the content of CMC dossiers to facilitate the management of future changes.
  • Prepares with contribution of site experts the answers to questions from Health Authorities.
  • Supports Marketing Authorizations worldwide (territory extensions, renewals, site registrations and transfers) by writing the corresponding CMC documents/dossiers and collecting GMP related documents from the site(s).
  • Consolidates regulatory activities in a planning tool.
  • Transversal activities
  • Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs for the site.
  • Ensures the Regulatory surveillance on their specific field of competencies and communicates the appropriate information to the site(s).
  • Provides results of regulatory indicators applicable to the site.
  • Implements the appropriate company tools to manage activities
  • Contributes to site inspections and audits.
  • Reviews and signs-off applicable documents (e.g., SOPs or technical reports).

HSE Requirement/Statement:

  • Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.
  • Context of the job/Major challenges:
  • This position requires a strong site and customer focus with ability to develop and execute regulatory and compliance excellence strategies.
  • Effectively manage site license and product dossier content with a strong understanding of the technical and industrial elements.
  • Incumbent will be required to effectively interact with various levels of stakeholders across the site such as Regulatory Affairs, Manufacturing & Supply and Global Sanofi functions.
  • Decisions can influence and affect business plans, departments and resources; errors can have significant consequences in terms of compliance and company performance.

Key Requirements:

  • Minimum of a Bachelor’s Degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.) preferred.
  • At least 3-5 years of Regulatory Affairs CMC experience, or combination of experience in a Quality role, in the pharmaceutical/biologics industry.
  • Experience working for a Regulatory Health Authority an asset.
  • Strong verbal and written communication skills to prepare accurate, clear, and comprehensive CMC dossiers; able to effectively communicate with internal and external audiences.
  • Self-motivated, detail oriented and results driven with excellent organizational ability.
  • Strong site and customer focus with ability to prioritize/adapt to changing business and manufacturing needs.
  • Strong problem-solving skills with ability to overcome risks/constraints.
  • Strong self-awareness and ability to understand role's impact/influence, as well as decision making ability

Must Haves:

  • Minimum of 3 years of applicable experience, will consider candidates that served in previous lead or management roles, no max or cap on years of experience
  • Must have strong have strong authoring experience
  • Must have previous pharm experience.
  • Previous experience and roles in Regulatory Affairs CMC experience, or combination of experience in a Quality role, in the pharmaceutical/biologics industry.
  • Technical documents, familiarity with authoring submission
  • Regulatory Affairs background seen as a plus Reviews and signs-off applicable documents (e.g., SOPs or technical reports). CTD Common Technical Documents

Nice to Haves:

  • Veeva experience is a plus
  • Change controls experience
  • Drug establishment licensing experience

  • Regulatory Affairs Specialist

    3 months ago

    Toronto, Canada McCain Foods Full time

    **Position Title**: Regulatory Affairs Specialist **Position Type**: Regular - Full-Time **Position Location**: Toronto HQ ; Florenceville-Bristol, New Brunswick, Canada **Grade**: Grade 04 **Requisition ID**: 32400 **Position Summary**: The Regulatory Affairs Specialist is responsible for product composition and label regulatory compliance for finished...

  • Regulatory Affairs Specialist

    3 months ago

    Toronto, Canada McCain Foods Limited Full time

    **Position Title**:Regulatory Affairs Specialist **Position Type**: Regular - Full-Time **Position Location**: Toronto HQ ; Florenceville-Bristol, New Brunswick, Canada **Grade**: Grade 04 **Requisition ID**: 32400 **Position Summary**: The Regulatory Affairs Specialist is responsible for product composition and label regulatory compliance for finished...

  • Regulatory Affairs Specialist

    5 days ago

    Toronto, Canada Raise Full time

    Regulatory Affairs Specialist II (Clinical)Location: Toronto, ON (Hybrid)Contract Length: 12 MonthsWe at Raise are hiring a Regulatory Affairs Specialist II (Clinical) for one of our top clients. After establishing themselves as an industry leader, they’re now expanding their team to meet rising demand.Responsibilities:Supports batch release by following...

  • Regulatory Affairs Specialist

    5 days ago

    Toronto, Canada Raise Full time

    Regulatory Affairs Specialist II (Clinical) Location: Toronto, ON (Hybrid) Contract Length: 12 Months We at Raise are hiring a Regulatory Affairs Specialist II (Clinical) for one of our top clients. After establishing themselves as an industry leader, they’re now expanding their team to meet rising demand. Responsibilities: Supports batch release by...

  • Regulatory Affairs Specialist

    5 days ago

    Toronto, Canada Raise Full time

    Regulatory Affairs Specialist II (Clinical)Location: Toronto, ON (Hybrid)Contract Length: 12 MonthsWe at Raise are hiring a Regulatory Affairs Specialist II (Clinical) for one of our top clients. After establishing themselves as an industry leader, they’re now expanding their team to meet rising demand.Responsibilities:Supports batch release by following...

  • Regulatory Affairs Specialist

    5 days ago

    Toronto, ON, Canada Raise Full time

    Regulatory Affairs Specialist II (Clinical) Location: Toronto, ON (Hybrid) Contract Length: 12 Months We at Raise are hiring a Regulatory Affairs Specialist II (Clinical) for one of our top clients. After establishing themselves as an industry leader, they’re now expanding their team to meet rising demand. Responsibilities: Supports batch release...

  • Regulatory Affairs Specialist

    5 days ago

    Toronto, ON, Canada Raise Full time

    Regulatory Affairs Specialist II (Clinical) Location: Toronto, ON (Hybrid) Contract Length: 12 Months We at Raise are hiring a Regulatory Affairs Specialist II (Clinical) for one of our top clients. After establishing themselves as an industry leader, they’re now expanding their team to meet rising demand. Responsibilities: Supports batch release...

  • Regulatory Affairs Specialist

    6 days 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...

  • Regulatory Affairs Specialist

    1 week ago

    Toronto, Ontario, C6A, Ontario, Canada Raise Full time

    Regulatory Affairs Specialist II (Clinical)Location: Toronto, ON (Hybrid)Contract Length: 12 MonthsWe at Raise are hiring a Regulatory Affairs Specialist II (Clinical) for one of our top clients. After establishing themselves as an industry leader, they’re now expanding their team to meet rising demand.Responsibilities:Supports batch release by following...

  • Regulatory Affairs Specialist for Pharmaceutical Industry

    3 weeks ago

    Toronto, Ontario, Canada Brunel Full time

    Job Title: Regulatory Affairs Specialist for Pharmaceutical IndustrySalary: $90,000 - $120,000 per yearAbout the JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Toronto, Ontario. As a key member of our regulatory team, you will be responsible for ensuring compliance with pharmacovigilance standards and regulations.Key...

  • Regulatory Affairs Specialist I

    6 months ago

    Toronto, Canada Boston Scientific Corporation Full time

    **Work mode**:Hybrid**Onsite Location(s)**:Toronto, CA**Additional Locations**: Canada-ON-Mississauga**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling...

  • Regulatory Affairs Specialist

    5 days ago

    Toronto, ON, Canada Pyramid Consulting, Inc Full time

    Immediate need for a talented Regulatory Affairs Specialist II . This is a 12+ Months Contract opportunity with long-term potential and is located in Toronto, ON (Hybrid) . Please review the job description below and contact me ASAP if you are interested. Employee benefits include, but are not limited to, health insurance (medical, dental, vision),...

  • Regulatory Affairs Specialist II

    7 days ago

    Toronto, Canada Pyramid Consulting, Inc Full time

    Immediate need for a talented Regulatory Affairs Specialist II . This is a 12+ Months Contract opportunity with long-term potential and is located in Toronto, ON (Hybrid). Please review the job description below and contact me ASAP if you are interested.Job ID:24-53180Pay Range: $45 - $50/hour. Employee benefits include, but are not limited to, health...

  • Regulatory Affairs Specialist II

    6 days ago

    Toronto, Canada Pyramid Consulting, Inc Full time

    Immediate need for a talented Regulatory Affairs Specialist II . This is a 12+ Months Contract opportunity with long-term potential and is located in Toronto, ON (Hybrid) . Please review the job description below and contact me ASAP if you are interested. Job ID:24-53180 Pay Range: $45 - $50/hour. Employee benefits include, but are not limited to, health...

  • Regulatory Affairs Specialist II

    6 days ago

    Toronto, Canada Pyramid Consulting, Inc Full time

    Immediate need for a talented Regulatory Affairs Specialist II . This is a 12+ Months Contract opportunity with long-term potential and is located in Toronto, ON (Hybrid). Please review the job description below and contact me ASAP if you are interested.Job ID:24-53180Pay Range: $45 - $50/hour. Employee benefits include, but are not limited to, health...

  • Regulatory Affairs Expert

    7 days ago

    Toronto, Canada Raise Full time

    Job Description:In this pivotal role as a Regulatory Affairs Specialist II (Clinical), you will play a crucial part in ensuring the regulatory compliance of products at our client's site(s). The ideal candidate will possess a strong understanding of cGMP documents, batch release processes, and Drug Establishment Licenses.Responsibilities:Regulatory...

  • Regulatory Affairs Specialist Ii

    5 days ago

    Toronto, ON, Canada Pyramid Consulting, Inc Full time

    Immediate need for a talented Regulatory Affairs Specialist II . This is a 12+ Months Contract opportunity with long-term potential and is located in Toronto, ON (Hybrid) . Please review the job description below and contact me ASAP if you are interested. Job ID: 24-53180 Pay Range: $45 - $50/hour. Employee benefits include, but are not limited to,...

  • Regulatory Affairs Specialist Ii

    5 days ago

    Toronto, ON, Canada Pyramid Consulting, Inc Full time

    Immediate need for a talented Regulatory Affairs Specialist II . This is a 12+ Months Contract opportunity with long-term potential and is located in Toronto, ON (Hybrid) . Please review the job description below and contact me ASAP if you are interested. Job ID: 24-53180 Pay Range: $45 - $50/hour. Employee benefits include, but are not limited to,...

  • Principal Compliance Specialist, Regulatory Affairs

    15 hours 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

    6 days ago

    Toronto, Ontario, Canada Pyramid Consulting, Inc Full time

    As a Regulatory Affairs Specialist with Pyramid Consulting, Inc., you will play a critical role in ensuring the compliance of our client's products with regulatory requirements.About the JobThis is a 12+ months contract opportunity with long-term potential and is located in Toronto, ON (Hybrid). The ideal candidate will have a strong understanding of CMC...