O pozici
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Co budeš dělat
- Work in accordance with local regulatory requirements and established Amgen procedures and practices.
- Support assigned tasks and assist with regulatory submissions to ensure compliance with corporate standards and local regulatory requirements.
- Assist in preparing and maintaining local labels to ensure they follow local legislation and Amgen standards and procedures.
- Prioritizes assigned daily work under supervision, in line with business needs.
- Assist with communicating with regulatory agencies as needed.
- Participates in preparing the filing plan (MA and lifecycle maintenance) and joins discussions with the local cross-functional team.
- Contributes to the execution of the filing plan (MA and lifecycle maintenance) for their country(ies) under supervision.
- Helps prepare regulatory submissions to ensure they are completed on time and meet Amgen’s corporate and local regulatory requirements.
- Assists in preparing and reviewing source text for country labeling and preparation of country artwork based on source text.
- Supports assigned clinical study activities in collaboration with Regional and Global Study Operations (GSO).
- Assists in reviewing simple promotional and non-promotional materials.
- Supports regulatory product compliance activities
- Assists in communicating with regulatory agencies to help fulfill local obligations.
- Helps the team prepare for participation in local agency interactions.
- Assists cross-functional colleagues under supervision to help achieve team goals.
- Shares regulatory information with other regulatory colleagues and cross-functional teams as needed.
- Assists Regional Regulatory Leads (RRLs) in regulatory development, registration, and lifecycle management activities.
- Cooperates with peers to help ensure consistency in procedures.
- Assists in building relationships with Agency staff for specific product assignments, as directed.
Koho hledáme
- Proficiency in English at B2 level or higher, proficiency in Czech.
- Basic understanding of regulatory principles.
- Ability to follow policies, procedures, and SOPs.
- Teamwork and communication skills.
- Willingness to learn and develop expertise.
- Bachelor’s degree in a life-science area.
- Entry-level professional knowledge and/or experience in life-science sector (pharmacy, laboratory, public institution, academia).
