Sr Associate Regulatory Affairs

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