Job Seekers

Responsible for developing global regulatory strategy for new assignments in oncology (e.g., marketing application strategy/planning for NMEs), with management oversight; driving submission related activities and successfully executing global 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 Global 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:

1. Actively seeks out knowledge of overall corporate strategy and other general factors that affect the regulatory positions taken within the company, and with 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.
2. Provides regulatory expertise for New Product Planning and Licensing due diligence activities

3. Member of important project teams/task forces requiring the interpretation of applicable
global regulations to ensure compliance
4. Sets direction for key operations and new initiatives. Works closely with other individuals/groups within Global Regulatory Affairs to influence others to ensure departmental consistency, and identifies options for risk discussions

5. Oversees submissions and compiles complex strategic submissions for assigned projects in oncology therapeutic area 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.
6. 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.
7. Manages the preparation and review of registration packages to ensure effective data presentation and quality scientific data against regulatory requirements.

8. Interacts with global health authorities on project related communications, including facilitating meetings such as Pre-IND, EOP1, EOP2, Scientific Advice, and pre-market application meetings

9. Revises regulatory strategy as necessary based upon scientific data, changes in the regulatory environment, global project direction, etc.
10. Interacts with other companies such as contract manufacturers, external development partners, and other subsidiaries such as APCA, API and APGD

* 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
* 6 years regulatory affairs experience preferably involving direct contact with the FDA and/or global regulatory authorities; 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 and/or global regulatory authorities. Regulatory experience in other therapeutic areas such as medical devices or biologics is desirable
* 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 Astellas 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