Allucent is hiring a
Regulatory Affairs Scientist / Senior Scientist

Summary

Join Allucent as a Regulatory Scientist or Sr. Scientist and assist clients with regulatory affairs related activities for drug, biologic, or medical device products.

Requirements

• 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

Responsibilities

• 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

Benefits

• 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