Director, Global Regulatory Lead, GI & Inflammation

About the role

The Director, Global Regulatory Lead, GI & Inflammation is responsible for defining, developing, and leading global strategies to maximize regulatory success for complex and/or multiple projects. They provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.

Responsibilities

• Defines and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
• Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
• Learns and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
• Manages direct reports or junior staff responsible for US FDA submissions and approvals of project(s) of responsibility.
• Participates with influence in or leads departmental and cross-functional task-forces and initiatives.
• Leads regulatory reviewer in due diligence for licensing opportunities.
• Partners with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
• Maintains compliance for products through working with regulatory regional leads, other functions, and vendors.
• Oversees vendor responsibility for regulatory activities and submissions related to projects within scope.

Requirements

Requires a Bachelor’s Degree in a scientific discipline, with an advanced degree in a scientific discipline (PharmD/PhD/MD) preferred. Eight (8) or more years of pharmaceutical industry experience, with six (6) years of regulatory experience or combination of four (4) years regulatory and/or related experience, is required. Solid working knowledge of drug development process and regulatory requirements is necessary, along with knowledge of FDA, EU, Canada, ROW, and post-marketing.

Qualifications

• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
• Proactive identification of regulatory issues and offering creative solutions and strategies, including risk mitigation strategies.
• Ability to work well with others and within global teams.

Skills

Must have strong skills with increasing independence in the area of regulatory strategy, 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.

Benefits

Takeda offers competitive compensation and comprehensive benefits, including:

• Base Salary Range: $177,000.00 - $278,080.00
• Short-term and long-term incentives
• Medical, dental, and vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time
• New hires eligible for up to 120 hours of paid vacation

Pay

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Schedule

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.