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 insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key 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.
• 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).
• Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.
• 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 Client functions.
• Decisions can influence and affect business plans, departments and resources; errors can have significant consequences in terms of compliance and company performance.
• 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 and Technology Experience:

• Skills- Authoring CMC, Module, Regulatory Affairs.
• 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.

Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here .