Regulatory Affairs Director

1 dzień temu

Warszawa, Mazovia, Polska Innovaderm Research Pełny etat
Job Title: Associate Director, Regulatory Affairs

Job Summary:

We are seeking an experienced Associate Director, Regulatory Affairs to join our team at Innovaderm Research. As a key member of our Regulatory Affairs group, you will be responsible for managing and overseeing the services provided by the team in assigned regions, ensuring they are conducted according to Innovaderm's standard operating procedures, applicable regulations, and good clinical practices.

Key Responsibilities:
  • Provide leadership on regulatory activities that lead to global start-up of clinical trials, planning and assigning work, overseeing the performance of direct reports, and performing annual reviews.
  • Oversee Regulatory Affairs activities of direct reports and in assigned regions to ensure quality deliverables on time, within budget, and in compliance with SOPs, industry standards, regulations, and study-specific requirements.
  • Manage performance, establish clear objectives and performance indicators, conduct formal performance reviews, and develop direct reports.
  • Plan regional adequate resources by forecasting project needs and overseeing recruitment efforts, ensuring adequate resources (headcount, experience, role) to sustain activities of the group.
  • Ensure adequate regional training of the team and oversee practices to ensure alignment of practices across the team through adoption and use of all process and technology tools.
  • Serve as a subject matter expert (SME) in regulatory within the department and to the organization, assisting with development of submission strategies.
  • Serve as a senior point of contact for project teams when issues related to regulatory activities must be escalated, ensuring communication is maintained and resolution is achieved.
  • Support strategic business expansion activities for new offerings and in new geographical regions.
  • Review documents and submissions prepared by the regulatory team, ensuring complete and timely response to Health Authorities during application review.
  • Lead departmental quality and process improvement initiatives, continuously monitoring, identifying, and reporting quality issues, developing proactive solutions, and initiating action plans.
  • Participate in request for proposals and requests for information for new studies, outlining regulatory strategies and evaluating project budgets at the proposal stage.
  • Ensure adequate monitoring of out-of-scope work by direct reports and accurate forecasting and recognition of departmental project revenue.
  • Oversee implementation of systems related to departmental activities, including change management, documentation of procedures, and training.
  • Oversee vendors and subcontractors supporting the department, ensuring adequate review of activities performed outside of the company by subcontractors to ensure high-quality standards before submission.
  • Write, review, and update related SOPs, tools, and working instructions for assigned regions, ensuring optimal use of templates, processes, and tools related to regulatory submission activities.
  • Ensure centralization of global changing regulatory requirements and maintenance of regulatory intelligence databases (regulatory information, submissions, and correspondence).
  • Point of contact for client audits, regulatory agency inspections, and serious breach committees, and participation in other meetings according to the company/client needs.
  • Participate in function and/or corporate initiatives and special project assignments.

Requirements:

  • Bachelor's degree (or equivalent) in life sciences or scientific discipline.
  • At least 8 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and/or CRO industry, including 3 years in a management role.
  • Experience preparing, reviewing, and submitting Clinical Trial Applications and IRB/IEC packages.
  • Solid knowledge of review and approval processes of applicable regulatory Health Authorities.
  • Ability to assess impact of evolving information and provide guidance.
  • Experience in team leadership; line management experience an asset.
  • Excellent knowledge of Microsoft Office suite.
  • Fluent in English with excellent oral and written communication skills; additional languages an asset.
  • Excellent interpersonal and intercultural communication skills.
  • Advanced ability to have a flexible risk approach and to adapt to changing business needs.
  • High ambiguity acceptance.
  • Client-focused approach to work and oriented toward problem-solving.
  • Respect established timelines, expectations, priorities, and objectives.
  • Good knowledge of good clinical practices, and applicable Health Canada, Food and Drug Administration (FDA), and local/national regulations/guidelines.

About Innovaderm Research:

Innovaderm Research is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

Innovaderm Research is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm Research will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Innovaderm Research only accepts applicants who can legally work in Poland.

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