Purpose and Scope:This position plays a key role in the regulatory affairs department. Responsible for developing regulatory strategy for new assignments outside of existing regulatory frameworks (e.g., NDA strategy/planning for NMEs), with management oversight; driving submission related activities and successfully executing regulatory strategies.
Responsibilities and Accountabilities:- Actively seeks out knowledge of overall corporate strategy and other general factors that affect the regulatory positions taken within the company, and with the FDA and global health authorities, and incorporates this knowledge in interactions with others. Will also impact corporate strategy directly by participating in global strategic planning within therapeutic area project teams.
- Provides regulatory expertise for New Product Planning and Licensing due diligence activities.
- Member of 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 to ensure departmental consistency and 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 the defined time schedules and meet established standards and SOPs.
- Is considered a regulatory expert by global project teams/task forces and is accountable for developing and recommending regulatory strategy. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidances.
- 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 guidelines.
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 EnvironmentThis position is based in Northbrook, IL. Remote work from anywhere in the US is available.
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
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
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