Our client is redefining cancer treatment by developing a broad portfolio of immune-oncology drug candidates. They are seeking a Regulatory Strategy Director or Sr. Director to join their Regulatory Science team which is aimed at bringing regulatory innovation to drug development and commercialization. The position is highly visible to internal and external stakeholders and requires political savvy and agility in building consensus and defending the regulatory position with global health authorities.
Responsibilities:
- Develop regulatory strategies integrated with cross-functional project teams to facilitate timely submissions and approvals
- Lead compilation of regulatory dossiers and ensure readiness for submission to health authorities
- Manage global regulatory sub-team for specific projects composed of regulatory CMC, regulatory operations, regulatory intelligence and regulatory managers responsible for major markets
- Provide strategic regulatory leadership to project teams to support the planning and conduct of clinical & CMC development leading to successful and fast registration
- Manage development projects with multiple, complex issues requiring extensive agency consultations and contingency and risk mitigation planning
- Ensure completion of regulatory deliverables, according to agreed project timelines and development plans
- Proactively influence and engage with healthcare environment and regulatory policy framework to facilitating approval and market penetration
- Identify issues from research, early development and evolving competitive intelligence that potentially would impact regulatory approval (risk analysis)
- Assesses project plans and timelines effectively to ensure projects are appropriately prioritized and key goals are met on time
- Evaluate current regulatory processes and assess opportunities for improvement
Qualifications:
- BS in a relevant life science discipline; preferably with an advanced degree (MS, PhD, PharmD)
- At least 10 years in regulatory development strategies in the pharma/biotech industry, managing complex projects and FDA, EMA and other major agency consultations
- Track record of regulatory approvals in oncology is a must, including hands-on experience across all phases of development and post-marketing
- In-depth understanding of the current European and US regulations and the wider regulatory environment and trends – and their implications for the global drug development process
- Knowledge of ICH, FDA and EMA guidelines and awareness of evolving regulatory environment
- Established network and credibility with health authorities and industry
- Innovative thinker with agility to create regulatory pathway for accelerated approval
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Ability to influence and lead cross-functional team toward successful negotiation with agency
- Ability to influence and interact effectively with internal and external customers
- Ability to work effectively across functions in drug development and commercial organizations
- Team player with good interpersonal skills
- Strong oral and written communication skills
- Good presentation, organization and planning skills