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Astellas is announcing an Associate Director, Regulatory Affairs in our Deerfield, IL location.

This position plays a key role in the regulatory affairs department. Independently responsible for multiple regulatory functions and can be a member of one of several regulatory groups. 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. Responsible for significant interactions outside the regulatory affairs department on complex issues and questions. Provides regulatory expertise in directing projects within assigned therapeutic areas including International Regulatory Support, Clinical Research and Development, Chemistry Manufacturing and Controls (CMC), Advertising/Labeling, Regulatory Operations and to the Global Project Team. Serves on increasingly more significant project teams/task forces. Also responsible for the coordination/training of regulatory staff as appropriate.

POSITION DUTIES:
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. Reviews regulatory submissions for accuracy, consistency and quality.
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. Independently determines the best way to position information in assigned regulatory submissions to maximize FDA reviewability. Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision.
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 such as APCA, API and APERD.
Defines and implements regulatory strategies and priorities, including original NDAs. Revises regulatory strategy as necessary based upon scientific data, changes in the regulatory environment, global project direction, etc.
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.

 

Scope:

Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. Establishes rapport with regulatory authorities that enables constructive exploratory discussions. Functions as the facilitator in FDA meetings. Impacts the company’s overall success including overall sales and risk management. Failure to perform functions could result in significant regulatory compliance and credibility issues.

Challenges:

Works on strategic, complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications on operations, revenue, and/or credibility. Position must anticipate regulatory issues for assigned projects and manage them proactively. Incorporate overall corporate strategy into interactions within Regulatory Affairs, with the FDA, with other global Regulatory Agencies and with external development partners.

SUPERVISORY RESPONSIBILITY:

Plays key role in selection, supervising, and ongoing training of Regulatory Affairs staff.
 

Position Requirements KNOWLEDGE & EXPERIENCE:

• Bachelor’s degree in scientific discipline; advanced degree preferred.

• 9 years previous pharmaceutical drug development experience, 2 in managing staff.

• 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.

• 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 in areas of CMC and product formulations. Regulatory experience in other therapeutic areas such as medical devices or biologics.

• 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.

• Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.

• Ability to communicate effectively and maintain effective working relationships. Must be able to positively influence department staff and other APGD groups.

• High integrity with respect to maintenance of proprietary, confidential information.

• Excellent written and oral communication skills, with writing ability to meet regulatory requirements and standards.

 

Please visit us at www.us.astellas.com to apply.