Career Category
Regulatory
Job 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).
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Salary Range
742,975.65 CZK - 1,005,202.35 CZK