Senior Manager Regulatory Affairs CZ&SK
About this opportunity
Career Category
Regulatory
Job Description
Senior Manager Regulatory Affairs CZ&SK
Full time position
Contract type: Amgen staff, indefinite period, fulltime
Pay Range: 1,796,631 - 2,430,735 CZK yearly gross
CZ&SK Affiliate Regulatory Head, Sr Manager provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.
Job Summary:
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).
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.
. Salary Range
CZK - CZK
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 145 comparable Manager Regulatory Affairs roles across 41 biopharma companies.
Salary context
37 of 145 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 145 comparable roles
+ 16 more countries
Seniority mix
145 of 145 peers have a known seniority level
Therapeutic area mix
22 of 145 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Open in 2 locations
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.