Canada-Regulatory Affairs Specialist II (Clinical)

Job title:

Canada-Regulatory Affairs Specialist II (Clinical)

Company

TalentBurst

Job description

Title: Regulatory Affairs Specialist II (Clinical)
Location: Toronto, ON
Duration: 12+ monthsDescription:
The Regulatory Site Office Manager plays a key role in maintaining regulatory compliance for marketed products. This involves efficiently handling all regulatory tasks within the site, ensuring timely and accurate execution as relates to the Chemistry, Manufacturing & Controls (CMC) and Facilities information. The manager oversees regulatory aspects related to change controls, supplier change notifications, and updating CMC and Facilities dossiers. The manager also supports the writing and maintenance of product licenses and site registrations. As a regulatory expert, the manager provides guidance on all regulatory matters and projects within the site, ensuring comprehensive knowledge and execution of regulatory requirements.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Main 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 company functions.
Decisions can influence and affect business plans, departments and resources; errors can have significant consequences in terms of compliance and company performance.Dimensions/Scope:
This position is at the interface between Manufacturing and Supply and Regulatory Affairs to manage and maintain the local site’s commercial product dossiers (products/drug substances/facilities/equipment) and establishment license. License dossiers and content will be developed to meet the ever-changing demands of the Regulatory Agencies and Industry while ensuring the Manufacturing and Supply Site team is able to meet production demands.
The position will also work closely with the Regulatory Affairs team for the assessment of site change controls.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#TB_PH

Expected salary

Location

Toronto, ON

Job date

Fri, 13 Dec 2024 08:52:54 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsnearcanada.com) you saw this job posting.