Description
**The Senior Associate in Regulatory Affairs** **supports** **country regulatory activities for** **the development, registration, and lifecycle management of all Amgen molecules** **.**
**Contract type: Amgen Paid Temp – contract for 1 year, fulltime job**
**Reports to:** **Associate Director Regulatory Affairs**
**Job summary:**
+ 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.
**Key activities:**
Strategy and Execution:
+ 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
Health authority interactions:
+ Assists in communicating with regulatory agencies to help fulfill local obligations.
+ Helps the team prepare for participation in local agency interactions.
Communication and Collaboration:
+ 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.
Required knowledge and skills:
+ 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.
Required education and experience:
+ Bachelor’s degree in a life-science area.
+ Entry-level professional knowledge and/or experience in life-science sector (pharmacy, laboratory, public institution, academia).
