Purpose and Scope:
Responsible for development, implementation, and change control of new and revised local labeling for assigned Astellas products and areas. 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.
Responsibilities and Accountabilities:
- Assures compliance of local labeling by evaluating all CCDS/CCSI changes and implementing according to prescribed timelines.
- Collaborates with Regulatory Leads on submission and implementation strategy for labeling.
- Advises cross-functional teams on labeling content consistency and best practices regarding planning and execution.
- Participates in cross-functional labeling review team meetings; organizes, compiles, and maintains all documentation and assures compliance of manual and electronic label history files.
- Actively supports the systems, processes, and operations for development of and changes to labeling, and assures compliance to those procedures.
- Participates in labeling development teams for regional product launches and ensures that all labeling meets company and regulating health authority specifications.
- Manages English Master files and has oversight of translation of text into local languages according to individual country requirements (where appropriate).
- Establishes strong working relationships with global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply.
- Discusses within the project team challenging labeling issues and contributes to team decisions based upon regulatory knowledge, but also recognizes when an issue or decision should be elevated to upper management for further consideration. Keep management apprised of critical issues which may impact the success of the organization.
Preferred Qualifications
Required Qualifications:
- Bachelor's degree.
- At least 6 years previous industry experience; 3 in RA.
- Direct pharmaceutical labeling development experience with proficiency in managing change control.
- Proficiency with health authority regulations & guidelines (e.g. ICH) for labeling development, implementation, and compliance requirements, and applies understanding to business situations
- Experience with stakeholders in the labeling system from content development through commercial supply
- Able to influence peers and others within the organization and maintain effective working relationships.
- Good organizational skills and high level of attention to detail, with the ability to coordinate multiple and diverse projects simultaneously.
- Excellent written and verbal communication skills (native and non-native English speakers).
Preferred Qualifications:
- 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.
Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
