Senior Director, Global Regulatory Lead, GI & Inflammation

About the role

The Senior Director will be responsible for complex or highly complex or multiple projects. They will lead the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represent GRTs at project team meetings. They will define strategies and provide tactical guidance to teams and collaborate cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.

Responsibilities

• Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings.
• Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.
• Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy.
• Ensures 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.
• Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or other staff responsible. The Senior Director will lead all submission types.
• Direct point of contact with health authorities, leads and manages FDA meetings and/or other regional HA meetings as appropriate. Manages direct reports or junior staff as needed.
• Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates with influence in or leads departmental and cross-functional task-forces and initiatives.
• Lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
• Maintain awareness of trends that impact both the regulatory and access environments to strengthen product development plans and adopt regulatory strategies in a timely manner.
• Responsible for demonstrating Takeda leadership behaviors.

Requirements

Requires a Bachelor’s Degree, scientific discipline strongly preferred, and an advanced degree in a scientific discipline (PharmD/PhD/MD) is strongly preferred. 12+ years of pharmaceutical industry experience, inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Experience in reviewing, authoring, or managing components of regulatory submissions. Expert knowledge of drug development process and regulatory requirements. Understanding of 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. Demonstrated ability to identify and mitigate regulatory issues, offer creative solutions and strategies.

Qualifications

• Bachelor’s Degree, scientific discipline strongly preferred
• Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred
• 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience.
• Experience in reviewing, authoring, or managing components of regulatory submissions.
• Expert knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
• Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
• Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Demonstrated ability to identify and mitigate regulatory issues, offer creative solutions and strategies, including risk mitigation strategies.

Skills

• Strong oral and written communications
• Managing and adhering to timelines
• Negotiation skills
• Integrity and adaptability
• Ability to identify and mitigate regulatory issues
• Offer creative solutions and strategies, including risk mitigation strategies

Benefits

Takeda offers competitive compensation and comprehensive 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

$212,000.00 - $333,190.00

Schedule

Full time