Sr Associate Regulatory Affairs

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).