O pozici
CZ&SK Affiliate Regulatory Head, Sr Manager provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.
Co budeš dělat
- The Cluster Regulatory Head (Sr. Manager) oversees the affiliate and manages a regulatory team 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).
- 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, including effective communication with senior stakeholders, presentation at affiliate and ELMAC Regulatory forum, and leadership in assigned ELMAC Regulatory initiatives.
Koho hledáme
- 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.
- 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.
- 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.
