Job Summary
The Manager, Regulatory Affairs (Operations) plays a crucial role in overseeing, structuring, and producing regulatory submission documentation, ensuring that workflows adhere to compliance standards across various departments. This position also involves offering specialized knowledge in the preparation of documents, managing submission schedules, and sustaining regulatory information management systems.
Responsibilities
- Manage and organize regulatory submission documents.
- Ensure compliance of workflows among different departments.
- Provide expertise in document preparation.
- Coordinate and oversee submission timelines.
- Maintain effective regulatory information management systems.
Qualifications
- Bachelor’s degree in a relevant field.
- Minimum of 7 years of experience in regulatory affairs operations.
- Experience with electronic Common Technical Document (eCTD) submissions.
- Proficient in document formatting and regulatory software such as Veeva or Lorenz docuBridge.
- Strong project management abilities and keen attention to detail.
Telix Pharmaceuticals (AMER) provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
