Regulatory Affairs Scientist / Sr. Scientist (Canada)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Regulatory Scientist or Sr. Scientist to join our A-team (hybrid*/remote). As a Regulatory Affairs Scientist or Sr. Scientist at Allucent, you are responsible for assisting clients with the regulatory affairs related activities for drug, biologic or medical device products. Responsibilities may include analysis, review and authoring of regulatory/scientific documents; leading or participating in Health Authority (HA) communication; as well as preparing regulatory content for various needs.munication; as well as preparing regulatory content for various needs.

In this role your key tasks will include:

• Reviews and/or writes regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought.
• Proficiency in HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
• Reviews and prepares HA meeting requests and briefing documents
• Leads HA meetings as Regulatory SME
• Interacts with HAs, Acts as a Regulatory Agent/Liaison for clients
• Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions
• Evaluates change impact and necessary HA reporting requirements and strategies for drug products or devices from development through post-approval management
• Knowledge & proficiency of CTD format and structure for regulatory submissions
• Understanding & proficiency in management of regulatory submissions planner including experience with eCTD submissions software
• Contributes to Due Diligence reviews/reports
• Acquires skills, knowledge and experience of increasingly complex documents, applications and submission types, amendments to existing applications through marketing applications and beyond.
• Develops knowledge and experience of different types of regulatory applications and submissions.
• Develops knowledge and experience of requirements in different regulatory regions as corporate needs dictate.
• Learns and keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality
• Mentors less experienced Regulatory Affairs Scientists
• Participates in interdepartmental communications to assist with compliance with regulations.
• Takes accountability for responsibilities in area of expertise
• Actively participates in and lead staff learning & development within the regulatory affairs staff
• Provides guidance and advises Project Leads and or Project Team
• Adherence to project budgets and contracts including scope and scope changes, timeline deliverables and active management of resources
• manages projects as a Consulting Technical Lead as assigned
• Leads and/or participates in client meetings
• Depending on level, position may have direct reports and will include development and performance management responsibilities as well as evaluation of utilization and capacity of direct reports
• Training on current and new regulatory requirements as well as developing and presenting internal and sponsor trainings
• Assists with development and presentation of internal and sponsor training
• Manages project team workload to meet or exceed sponsor deadlines
• Awareness and understanding of impact of project budgets, contracts and scope, timeline deliverables and active management of resources
• Applies company policies and procedures to resolve a variety of issues
• Identifies and mitigates risk
• Assures good communication and relationships with (future) clients
• Contributes to Business Development proposals; containing regulatory documents/ interactions, assists with bid defenses when requested
• Performs other scientist related duties as assigned

Requirements

To be successful you will possess:

• B.Sc., M.Sc., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
• Regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for US, EU, and / or Canada
• Depending on level >2 years' experience (for Scientist); >4 years’ experience (for Sr. Scientist) with regulatory requirements of US FDA, Health Canada and / or European authorities.
• RAC credentials preferred
• Critical thinking and analytical skills, as well as strong written and verbal communication skills in English
• Scientific and regulatory knowledge of drug, biologic, or device development, desirable
• Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
• Quality focus
• Emotional intelligence, customer focused leadership and decision making skills
• Innovative, creative, and practical thinking including problem-solving skills

• Ability to work in an office environment with ability to lift up to 25 pounds, if required
• Travel may be required

Benefits

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

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