Description
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.
We are looking for someone who has:
- Experience as a lead and escalation point of contact for global projects.
- At least 8 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:
- Oversees 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.
- Manages performance, establishes clear objectives and performance indicators, conducts formal performance reviews and talent conversation meetings, and develop direct reports.
- Plans regional adequate resources by forecasting project needs and overseeing recruitment efforts Ensures adequate resources (i.e., headcount, experience, role). and training to sustain activities of the group.
- Ensures adequate regional training of the team and oversees practices to ensure alignment of practices across the team through adoption and use of all process and technology tools.
- Serves as subject matter expert (SME) in regulatory within the department and to the organization. Assists with development of submission strategies.
- Serves 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. Assists with sponsor interactions as required. Escalate issues and communicates projects risks to Management as necessary.
- Supports strategic business expansion activities for new offering and in new geographical regions.
- Reviews documents and submissions prepared by the regulatory team. Ensures complete and timely response to Health Authorities during application review. May perform regulatory project tasks (label text review, preparation/review of ICF, and preparation of IRB/regulatory applications) as appropriate based on resourcing gaps, timelines, or training needs.
- Lead departmental quality and process improvement initiatives. Continuously monitors, identifies, and reports quality issues, develop proactive solutions, and initiate action plans. Liaise with cross-functional leads. Initiates the development of practices, tools, processes, and training materials.
- Participates in request for proposals and requests for information for new studies, outlines regulatory strategies and evaluates project budgets at the proposal stage. Presents regulatory services in bid defense meetings. Provides feedback on the costing structure of the regulatory services.
- Ensures adequate monitoring of out-of-scope work by direct reports and accurate forecasting and recognition of departmental project revenue. Evaluates budget metrics.
- Oversees implementation of systems related to departmental activities (e.g., start-up module, IRB-TMF connector), including change management, documentation of procedures, and training.
- Oversees vendors and subcontractors supporting the department (eg, central IRB, partner CROs, vendors, consultants). Ensures adequate review of activities performed outside of the company by subcontractors to ensure high quality standards before submission.
- Writes, reviews, and updates related SOPs, TOOLs, and Working Instructions for assigned regions. Ensures optimal use of templates, processes, and tools related to regulatory submission activities.
- Ensures centralization of global changing regulatory requirements and maintenance of regulatory intelligence databases (regulatory information, submissions, and correspondence). Participates in regulatory watch activities.
- Point of contact for client audits, regulatory agency inspections, and serious breach committees, and participation in other meetings according to the company / client needs.
- Participates in function and/or corporate initiatives and special project assignments.
- Maintains familiarity with relevant current industry practices and regulatory requirements and guidelines. Maintains high level knowledge about regional regulations in the area of company interest.
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 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.
Work location
Note that this opening is for a home-based position in Germany
Regular travel, which may include overnight trips and / or international travel is required as part of this role.
About Innovaderm
Innovaderm 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 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 Germany.
