Senior Director, Global Regulatory Affairs, Oncology

Main Responsibilities

• Overall Accountability: Provide regulatory strategic leadership for the assigned program(s). Be accountable for the development, flawless execution and implementation of regulatory strategic activities for the assigned programs for assigned region(s) or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products.
• Product/Project Leadership: Be accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs, either directly or through the supervision of the Regulatory Asset Team Member.
• Regulatory Input: Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics). Provide regulatory input into the Integrated Asset Strategic Plan. In collaboration with other departments, define the optimal plan to reach the target product profile, taking into consideration the most favorable timing for all key markets.
• Evaluation and Adaptation: Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with relevant functions and Asset Team/Sub-teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; propose remediation where possible.
• Strategy Definition: Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards). Lead the preparation of submissions incl PIP, scientific advice, orphan drug designation submissions. Advocate to and seek buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies.
• Risk Management: Be responsible for ensuring potential risks have been identified and mitigation options are proactively proposed for project team and senior management decision making.
• Execution and Implementation: Be responsible for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen tools and processes.
• Communication and Collaboration: Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. Review and provide input into all key documentation relevant to Franchise plans as required.
• Outsourcing and Performance: Ensure outsourced activities are delivered on time and on budget. Identify and alert management regarding any service issues. Oversee regulatory activities assigned to his/her direct reports where applicable and manage performance and all applicable processes.
• People Management: Contribute towards effective planning of the GRA budget. Support recruitment, train, develop and retain regulatory professionals within GRA.
• Compliance and Ethics: Be accountable for ensuring all activities are conducted in line with Ipsen’s ethics and compliance policies.

Qualifications

• Significant experience in the pharmaceutical industry, including minimum 15 years in Regulatory Affairs.
• Proven experience of drug development/registration and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies.
• Track record of building excellent relationships with FDA and/or EU and Asia Pacific (mainly China and Japan) regulatory environment.
• Excellent written and oral communication skills.
• Strong interpersonal and negotiation skills with a proven ability to build strong personal networks, both within and outside Ipsen and use them to secure appropriate support and outcome for a project.
• Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
• Constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process.

Preferred Qualifications

• Knowledge of medical device / drug device combination regulations would be a plus.

Education & Certifications

• Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences).

Language

• Fluent in English.

Pay Range

The annual base salary range for this position is $270,000 to $330,000.

Benefits

• 401(k) with company contributions
• Group medical, dental and vision coverage
• Lifetime disability insurance
• Short- and long-term disability insurance
• Flexible spending accounts
• Parental leave
• Flexible time off
• Discretionary winter shutdown
• Well-being allowance
• Commuter benefits