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