Senior Manager Regulatory Affairs CZ&SK

Senior Manager Regulatory Affairs CZ&SK

Amgen

Prague, Czech Republic

Job Summary

The Cluster Regulatory Head (Sr. Manager) oversees the affiliate and manages a regulatoryteam to ensure delivery of assigned local and ELMAC Regulatory initiatives in line with applicable regulatory and Amgen requirements. This role can also be assigned to one or more Amgen products.

• First point of contact for interactions with local regulatory agency(ies).
• Ensure that the local Regulatory staff delivers assigned local and ELMAC Regulatory initiatives across the affiliates.
• Represent Regulatory on the affiliate leadership team.
• Provide local regulatory input to support development and execution of assigned Regulatory Affairs initiatives and effective interactions with key regulatory agency(ies).
• Supervise and oversight for one or more regulatory staff.
• Manage and liaising with distributors (if applicable).

Key Activities

STRATEGY AND EXECUTION

• Translates assigned global, regional and ELMAC Regulatory initiatives into local regulatory objectives where applicable.
• Acts as senior point of contact for local regulatory advice on commercial and medical activities within the affiliate.
• Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with own team and local cross-functional team.
• Executes the filing plan (MA and Lifecycle maintenance) for their affiliate, where applicable.
• Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
• Creates, reviews and approves source text for affiliate labeling, and owns the affiliate artwork based on source text (where applicable).
• Reviews the promotional and non-promotional materials (where applicable).
• Monitors assigned regulatory changes in national legislation and local trade association activities, assesses local regulatory impact and communicates this impact to relevant stakeholders.

MANAGEMENT

• Oversees the department framework to comply with local codes and legislation and Amgen policies and procedures.
• Provides advice, guidance and support to Regulatory staff.
• Recruits and retains talented regulatory staff.
• Provides coaching, mentoring and development of Regulatory staff.
• Develops regulatory team members to build readiness for increased scope of responsibility, including effective communication with senior stakeholders, presentation at affiliate and ELMAC Regulatory forum, and leadership in assigned ELMAC Regulatory initiatives.
• Ensures staff are compliant with Amgen corporate and departmental training.
• Disseminates relevant information to the team, as appropriate.
• Is accountable for delivery of assigned local and ELMAC Regulatory objectives, including contributions to regional initiatives.
• Provides input to budget and headcount planning.
• Leads and participates in assigned local and ELMAC Regulatory regulatory process improvements and trainings aligned with Regulatory priorities.
• Tracks metrics for team deliverables.
• Ensures approval and maintenance of local products, clinical trials.
• Supports the monitoring, auditing and self-assessment activities.
• Represents Regulatory on affiliate leadership team.

COMMUNICATION AND COLLABORATION

• Collaborates with Global Study Operations (GSO) to support local planning and execution for clinical studies in accordance with national, legal and regulatory requirements (where appropriate).
• Ensures that affiliate develops, implements and maintains Regulatory processes and procedures.
• Ensures local implementation of assigned regulatory projects, including ELMAC Regulatory initiatives where applicable.
• Exchanges regulatory information with other regulatory colleagues on an ongoing basis and provides timely local regulatory advice, where applicable.
• Partners where required with Regulatory colleagues to support the regulatory development, registration, and lifecycle management of all Amgen molecules.
• Leads assigned ELMAC Regulatory Affairs initiatives, ensuring timely delivery, regional coordination, and alignment with functional priorities.
• Collaborates cross-functionally to support implementation of assigned regulatory initiatives in line with national regulatory requirements.
• Communicates clearly and in a timely manner with key stakeholders across the business.

​EXTERNAL INTERACTIONS

• Manages Distributors, Functional Service Providers (FSP) and Vendors and keeps an ongoing relationship, as required.
• Represents Regulatory Affairs in local industry and trade association interactions, limited to assigned regulatory matters relevant for the affiliate and national legislation.

HEALTH AUTHORITY INTERACTIONS

• Leads and contributes to local regulatory strategy and attends Health Authority meetings.

Knowledge and Skills

Scientific and Technical

• Experience working with local service providers, distributors and/or contractors and regional regulatory agencies, as applicable.
• Ability to lead teams and develop effective teams.
• Ability to understand and communicate scientific/clinical information.
• Understanding of regulatory activities and how it affects projects and processes.
• Ability to set organizational direction & champion change and continuous improvement.
• Ability to anticipate and mitigate future strategic issues & uncertainties.
• Ability to input effectively on multi-functional affiliate leadership team.

Others

• Demonstrate strong teamwork ability.
• Good communication skills - both oral and written. English and Czech and/or Slovak language working proficiency.
• Good negotiation and Influencing skills.
• Ability to anticipate and prevent potential issues.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
• Cultural awareness and sensitivity to achieve results across both regional, affiliate and international borders.
• Ability to manage multiple activities and set priorities.

Education and Experience

• Doctorate degree and 2 years of directly related experience; OR
• Master’s degree and 6 years of directly related experience; OR
• Bachelor’s degree and 8 years of directly related experience.
• Degree and in-depth regulatory experience and/or related to the affiliate.
• Depth knowledge of affiliate legislation and regulations relating to medicinal products.