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Associate Director, Regulatory Affairs Specialist
hace 2 meses
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 in the assigned regions, ensuring they are conducted according to our standard operating procedures, applicable regulations, good clinical practices, and the Sponsor's satisfaction.
Key Responsibilities- Leadership and Oversight
- Provide leadership on regulatory activities that lead to global start-up of clinical trials.
- Plan and assign work, oversee the performance of direct reports, and perform annual reviews.
- Address employee relation issues and escalate issues as necessary.
- Regulatory Expertise
- Oversee Regulatory Affairs activities of direct reports 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 resources by forecasting project needs and overseeing recruitment efforts.
- Ensure adequate regional training of the team and alignment of practices across the team.
- Serve as subject matter expert (SME) in regulatory within the department and assist with submission strategies.
- Serve as a senior point of contact for project teams on regulatory activities.
- Support strategic business expansion activities.
- Review documents and submissions prepared by the regulatory team.
- Lead departmental quality and process improvement initiatives.
- Participate in request for proposals and outline regulatory strategies.
- Ensure adequate monitoring of out-of-scope work by direct reports.
- Oversee implementation of systems related to departmental activities.
- Oversee vendors and subcontractors supporting the department.
- Write, review, and update related SOPs, tools, and working instructions.
- Centralize global changing regulatory requirements and maintain regulatory intelligence databases.
- Act as point of contact for client audits and regulatory agency inspections.
- Participate in function and/or corporate initiatives and special project assignments.
- Maintain familiarity with relevant current industry practices and regulatory requirements.
- Education
- Bachelor's degree (or equivalent) in life sciences or scientific discipline.
- Experience
- 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.
- Knowledge and Skills
- 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 is an asset.
- Excellent knowledge of Microsoft Office suite.
- Fluent in English with excellent oral and written communication skills; additional languages are an asset.
- Excellent interpersonal and intercultural communication skills.
- Advanced ability to have a flexible risk approach and 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 regulations.
Innovaderm Research is a contract research organization (CRO) specialized in dermatology. Our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. We offer a stimulating work environment and attractive advancement opportunities.
We are committed to providing equitable treatment and equal opportunity to all individuals. As such, we will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
We only accept applicants who can legally work in Spain.
