Regulatory Affairs Lead, Oncology (Associate Director)

About Astellas

Astellas is a global life sciences company dedicated to transforming innovative science into value for patients. They provide transformative therapies in areas such as oncology, ophthalmology, urology, immunology, and women's health. Astellas is committed to pioneering new healthcare solutions for diseases with high unmet medical needs. For more information, visit Astellas.com.

Purpose and Scope

This position plays a key role in the regulatory affairs department. The role involves developing regulatory strategy for new assignments outside of existing regulatory frameworks (e.g., NDA strategy/planning for NMEs), driving submission-related activities, and successfully executing regulatory strategies. The position also impacts corporate strategy directly by participating in global strategic planning within therapeutic area project teams.

Responsibilities and Accountabilities

• Actively seeks out knowledge of overall corporate strategy and other general factors affecting the regulatory positions taken within the company, incorporating this knowledge in interactions with others.
• Participates in global strategic planning within therapeutic area project teams.
• Provides regulatory expertise for New Product Planning and Licensing due diligence activities.
• Maintains membership in important project teams/task forces requiring the interpretation of applicable FDA/ICH regulations to ensure compliance.
• Sets direction for key operations and new initiatives.
• Works closely with other individuals/groups within Regulatory Affairs to influence others and ensures departmental consistency.
• Identifies options for risk discussions.
• Oversees submissions and compiles complex, strategic submissions for assigned projects.
• Ensures that the compilation and transmission of submissions are within defined time schedules and meet established standards and SOPs.
• Manages the preparation and review of registration packages to ensure effective data presentation and quality scientific data against regulatory requirements.
• Independently manages complex technical documents for preparation, review, and submission to regulatory agencies.
• Interacts with FDA and global health authorities on project-related communications, including facilitating Divisional and committee meetings such as Pre-IND, IND, Pre-NDA, and NDA meetings.
• Interacts with other companies such as contract manufacturers, external development partners, and other subsidiaries.
• Assists with ongoing training of Regulatory Affairs staff.
• Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidances.

Required Qualifications

• Bachelor’s degree in scientific discipline; advanced degree preferred.
• 9 years previous pharmaceutical drug development experience.
• Recognized as an expert in regulatory aspects of pharmaceutical drug development involving undefined frameworks with technical complexity and broad scope.
• Scientific knowledge in chemistry, general biological/physical science, and ability to apply that knowledge to regulatory issues and product development.
• Recognized as an expert in an aspect of pharmaceutical drug development.
• Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to direct reports and others in the department as needed.
• Ability to communicate effectively and maintain effective working relationships.
• Must be able to positively influence department staff and cross-functional teams.

Preferred Qualifications

• Oncology experience strongly preferred.
• 6 years regulatory affairs experience, preferably involving direct contact with the FDA.
• Full knowledge of FDA and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
• Proven record of successful IND/NDA submissions and negotiations with the FDA.
• Global submission experience strongly desired.

Location and Working Environment

This position is based in Northbrook, IL. Remote work from anywhere in the US is available. Astellas offers a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. Employees can expect to work 40 hours per week, with a mix of remote and in-office work depending on the team and project needs.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Salary Range

$144,060 - $205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations).

Benefits

• Medical, Dental, and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions
• Referral bonus program

Equal Opportunity Employer

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.