Associate Director, Regulatory Affairs (Spain)
Spain
CRO - Regulatory Affairs
Full time
The Associate Director, Regulatory Affairs is responsible for managing and overseeing the services provided by the Regulatory Affairs group in the assigned regions, and to ensure they are conducted according to Innovaderm’s standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction.
Responsibilities include:
* Providing 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.
* Addressing employee relation issues, and escalating issues as necessary.
We are looking for someone who has:
* Experience as a lead and escalation point of contact for global projects.
* At least years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry.
* Experience with oversight of preparing and submitting part I and/or part II Clinical trial applications following EU CTR.
More specifically, the Senior Manager, Regulatory Affairs must:
* Oversee Regulatory Affairs activities of direct reports and in assigned regions to ensure quality deliverables on time, within budget, and in compliance to SOPs, industry standards, regulations, and study-specific requirements.
* Manage performance, establish clear objectives and performance indicators, conduct formal performance reviews and talent conversation meetings, and develop direct reports.
* Plan regional adequate resources by forecasting project needs and overseeing recruitment efforts.
* Ensure adequate resources (headcount, experience, role) and training 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 subject matter expert (SME) in regulatory within the department and to the organization. Assist with development of submission strategies.
* Serve as a senior point of contact for project teams when issues related to regulatory activities must be escalated to ensure communication is maintained and resolution is achieved.
* Support strategic business expansion activities for new offering and in new geographical regions.
* Review documents and submissions prepared by the regulatory team. Ensure complete and timely response to Health Authorities during application review.
* Lead departmental quality and process improvement initiatives. Continuously monitor, identify, and report quality issues, develop proactive solutions, and initiate action plans.
* Participate in request for proposals and requests for information for new studies, outline regulatory strategies and evaluate 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 and ensure adequate review of activities performed outside of the company by subcontractors.
* Write, review, and update related SOPs, tools, and working instructions for assigned regions.
* Ensure centralization of global changing regulatory requirements and maintenance of regulatory intelligence databases.
* Act as point of contact for client audits, regulatory agency inspections, and serious breach committees.
* Participate in function and/or corporate initiatives and special project assignments.
* Maintain familiarity with relevant current industry practices and regulatory requirements and guidelines.
REQUIREMENTS
Education:
* Bachelor’s degree (or equivalent) in life sciences or scientific discipline.
Experience:
* At least years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry including 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 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.
OUR COMPANY
The work environment:
At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
* Permanent full-time position
* Company benefits package
* Ongoing learning and development
About Innovaderm:
Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings, 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 is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Innovaderm only accepts applicants who can legally work in Spain.
#J-18808-Ljbffr