Senior Manager Regulatory Affairs CZ&SK Job at Amgen (Prague)

Job Description

Senior Manager Regulatory Affairs CZ&SK. Czech Republic - Prague. SALARY RANGE: -. Contract type: Amgen staff, indefinite period, fulltime. CZ&SK Affiliate Regulatory Head, Sr Manager provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules. 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).

Job Responsibility

Provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules
Oversee the affiliate and manage a regulatory team to ensure delivery of assigned local and ELMAC Regulatory initiatives
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)
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
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
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
Collaborates with Global Study Operations (GSO) to support local planning and execution for clinical studies in accordance with national, legal and regulatory requirements
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
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
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
Leads and contributes to local regulatory strategy and attends Health Authority meetings

Requirements

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
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
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
Demonstrate strong teamwork ability
Good communication skills - both oral and written

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Senior Manager Regulatory Affairs CZ&SK

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