Associate Director, Global Regulatory Lead, Oncology

About the role

Takeda is a forward-looking, world-class R&D organization dedicated to unlocking innovation and delivering transformative therapies to patients. We focus on four therapeutic areas and other targeted investments to advance life-changing therapies globally.

Responsibilities

• Define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
• May lead the Global Regulatory Teams (GRTs) for assigned projects.
• May serve as global and/or regional regulatory lead as a member of a GRT.
• Primary FDA contact for projects of responsibility.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility.
• Act as direct point of contact with health authorities and lead and manage FDA meetings.
• Define strategies, provide tactical guidance to teams, and collaborate cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.
• Collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility.
• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Participate with influence in or lead departmental and cross-functional task-forces and initiatives.
• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
• Lead regulatory assessment as part of due diligence teams for licensing opportunities.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Responsible for demonstrating Takeda leadership behaviors.
• Participate with influence in or leads departmental and cross-functional task-forces and initiatives.

Requirements

• Bachelor’s Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline strongly preferred.
• 6+ years pharmaceutical industry, inclusive of regulatory and/or related experience.
• Solid working knowledge of drug development process and regulatory requirements.
• Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Demonstrate acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

Qualifications

• Must work well with others and within global teams.
• Able to bring working teams together for common objectives.

Skills

• Excellent communication and collaboration skills.
• Ability to manage and adhere to timelines.
• Negotiation skills.
• Integrity and adaptability.
• Proactive identification of regulatory issues.
• Offering creative solutions and strategies, including risk mitigation strategies.

Benefits

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Pay

$154,400.00 - $242,550.00

Schedule

Hybrid