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Astellas Pharma Sr. Manager, Global Regulatory Labeling in Northbrook, Illinois

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 development, implementation, and change control of new and revised labeling for assigned Astellas products and areas within the Rest-of-World (ROW) region. Ensures compliance with Company Core Data Sheets, applicable regional health authority requirements, and internal procedures and alignment with business needs. Research government initiatives related to labeling and packaging and assures that Astellas adopts new initiatives according to prescribed timelines. Requires significant interaction outside the Regulatory Affairs department on complex issues and questions. Maintains a positive working relationship with global internal stakeholders and business partners.

Essential Job Responsibilities:

  • Drives labeling development for regional product launches and ensures that all labeling meets company and regulating health authority specifications.

  • Manages English Master files and translation of text into local languages according to individual country requirements (where appropriate).

  • Serves as leader of cross-functional labeling review team meetings; organizes, compiles, and maintains all documentation and assures compliance of manual and electronic label history files.

  • Assures compliance of local labeling by evaluating all CCDS/CCSI changes and implementing according to prescribed timelines.

  • Advises cross-functional teams on labeling content consistency and best practices regarding planning and execution.

  • Collaborates with Regulatory Affairs cross-functional teams on submission and implementation strategy for labeling.

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

  • Establishes strong working relationships with global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply.

  • 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 or indirect impact on the labeling and labeling compliance for assigned

brands marketed and in development for the ROW International Markets.

Organizational Context:

This position will independently interface with local and global team members from the Associate level to the Senior Director level. The position reports to the Regulatory Affairs ROW Labeling Implementation, Associate Director. It may be an individual contributor role or may have direct reports.

Qualifications:

Required

  • Bachelor's or MS Degree in Pharmacy or other Life Science or equivalent by experience

  • At least 6 years previous industry experience; 3 years in Regulatory Affairs, including working within a global environment

  • Direct pharmaceutical labeling development experience required with demonstrated proficiency in managing change control.

  • Experience with managing projects and working within a matrixed organization

  • Knowledge of Regulatory landscape, systems and procedures for CCDS and Labeling

  • Proficiency in English language

  • Excellent communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders

  • Proven affinity and capability to work within teams where there is no direct reporting relationship.

Preferred

It is recognized that this role will require considerable regulatory and leadership experience, a good track record, and clear leader behaviors focused at collaboration & shared accountability.

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 Regulatory Affairs

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

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