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Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy)

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects CMC data required for regulatory submission packages. Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Utilizes working knowledge of CMC to effectively interpret CMC development and changes and determine the impact on the project or product and the application.

Essential Job Responsibilities:

• Acts as CMC regulatory lead or deputy for complex projects/products, requiring advice from manager on complex issues.

• Manages technical documents for preparation, review and submission to regulatory agencies. Prepares INDs/CTAs & NDAs/MAAs, amendments & supplements, as well as responses to questions from regulatory agencies. Assesses scientific data against regulatory requirements and reviews submissions against regulatory strategy. Ensures proper CMC Dossier Management, including document version control.

• Ensures compilation and transmittal of submissions are within defined schedules and meet Health Authority and Astellas established standards/SOPs.

• Develops approach for new assignments having less-defined regulatory frameworks with management oversight.

• For assigned projects, monitors and facilitates resolution of CMC issues that have potential for regulatory impact.

• Regularly interacts with functional peer groups internally and externally, occasionally with senior management.

• Advises local teams on regulatory requirements. Interprets and ensures compliance with applicable Health Authority/ICH regulations.

• Stays informed of changes in Health Authority regulations and expectations, and shares lessons with others.

Qualifications Required:

• Bachelor’s degree in scientific or related discipline.

• Minimum 6 years previous industry experience; three years in RA.

• Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development.

• Experience/expertise in an aspect of pharmaceutical drug development.

• Knowledge of Health Authority and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.

• Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to others in the department as needed.

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

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

• 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.

• High computer literacy.

Preferred:

• Advanced academic degree (MS, Ph.D. or Pharm.D.), with extensive (5+ years) and relevant experience in product development in the manufacturing or regulatory field.

• Advanced, interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment; able to manage complex projects by exercising independent decision making and analytical thinking skills; knowledge/experience of Health Authority regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance; ability to work in cross functional and international environment; detail- and goal-oriented, quality conscientious, and customer-focused; ability to adhere to strict project timelines; strong team player; good judgment and problem solving skills, with ability to identify, analyze, and resolve problems in a timely manner; fluent written and spoken English is required.

• Additional experience, such as biologics, vaccines, cell/gene therapy or medical devices is preferred.

Working Environment:

• 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: $114,800-153,000 (NOTE: Final salary could be more or less, based on experience)

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 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

• Referral bonus program

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Category Regulatory Affairs CMC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans