Associate Director, Regulatory Affairs, Labeling Strategy CCDS

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:

Collaborate with strategic regulatory for development of regulatory strategy and support in the area of CCDS and product labeling for products in development programs as well as life cycle management of existing portfolio for key country labeling. Provide oversight to other Regulatory personnel including regional leads and ROW labeling implementation leads who are responsible for developing labeling/packaging or managing labeling content and ensure consistency across product labels.

Advise global internal stakeholders and business partners on best practices regarding planning and execution of labeling strategies. Collaborates to assure labeling-relevant aspects of global and local regulatory strategies reflect best in class applications and meets all applicable regulatory and business requirements.

Essential Job Responsibilities:

• Functions as the CCDS Labeling Lead responsible for leading the creation, implementation and maintenance of the Company Core Data Sheets applying scientific and clinical knowledge to the process.

• Manages labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.

• Provide oversight to other Regulatory personnel including regional leads and ROW labeling implementation leads who are responsible for developing labeling/packaging or managing labeling content and ensure consistency across product labels.

• Uses the appropriate company systems, processes, and operations for development of and changes to labeling. Assures that cross-functional labeling processes are compliant with approved company procedures and manages process improvement initiatives.

• Advises cross-functional teams on labeling content consistency and best practices regarding planning and execution. Participate in identification of risk areas and develops alternative courses of action including anticipation of HA responses through scenario planning and development of contingency plans.

• Effectively applies strong working knowledge of FDA, EU, Japan, and China guidance, labeling standards and medical and scientific content.

• Actively supports the systems, processes, and operations for development of and changes to CCDS and key labeling and assures compliance to those procedures.

• Establishes strong working relationships with local and global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply. Works closely with individuals/groups to influence others to facilitate consistency, efficiency, quality and compliance.

• Makes and executes challenging decisions based upon sound regulatory knowledge, but also recognizes when a decision should be elevated to upper management for further consideration. Keep management apprised of critical issues which may impact the success of the organization.

Quantitative Dimensions:

This position will have direct impact on the development of local labeling, execution of labeling changes, coordination of global labeling strategies for execution of CCDS updates, and labeling compliance for Astellas marketed products for the U.S.,EU, Japan, and China. Indirect impact on the successful registration of new products, indications, and line extensions. The estimated revenue generation from a given product is between $10-500 million per year per region.

Organizational Context:

This position will independently interface and effect decisions with local and global team members (e.g., Pharmacovigilance, Risk Management, Regulatory Affairs Strategy, Marketing, Medical Affairs, Legal, Astellas Supply Chain, various technical and scientific areas, ) from the Associate level to the Senior Director level, and with external business partners. The position reports to the Director, Regulatory Affairs CCDA and Labeling Strategy in US Regulatory Affairs. The individual may be an individual contributor role or may have direct reports at the manager level.

Qualifications:

Required

• Bachelor's degree.

• At least 9 years previous industry experience; 6 years' experience in Regulatory Affairs in the area of labeling development.

• Demonstrated expert proficiency in managing and control of pharmaceutical labeling in accordance with local and global regulatory requirements. Direct pharmaceutical labeling development experience required.

• Proven proficiency with relevant key country local health authority regulations and guidelines for labeling development, implementation, and compliance requirements, and applies understanding to business situations.

• Proven effectiveness with stakeholders in the labeling system from content development through commercial supply.

• Previous experience working with US and ex-US labeling requirements, company core data sheet (CCDS) implementation and execution, and other regulatory requirements impacting or associated with labeling.

• Must be able to effectively influence peers both inside and outside the organization and maintain effective working relationships.

• Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously.

• Excellent written and verbal communication skills (native and non-native English speakers).

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

Preferred:

• Bachelor's degree in scientific discipline; advanced degree preferred

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

• Previous experience managing direct reports

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

• Referral bonus program

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Category Medical & Development

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