Regulatory Affairs Manager - Latvia
About this role
Regulatory Affairs Manager - Latvia
Diverse Minds. Bold Disruptors. Meaningful Impact.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.
It’s our patients that come first, every decision we make and action we take is centered around how we can better respond to their evolving needs, as well as those of healthcare professionals and partners. It’s why we are shaping patient care for the future, working along the whole experience to give hope to billions of lives across the world.
What you’ll do
Join us as a Regulatory Affairs Manager to secure our license to operate by delivering regulatory services across specific therapeutic areas in Latvia. You will own end to end regulatory activities for assigned therapeutical areas, ensuring timely submissions, approvals, and lifecycle management in line with local and EU requirements. In a complex and evolving regulatory environment, you will safeguard AZ’s reputation and make ethical, compliant decisions that support external activities. You will ensure adherence to regulatory agency requirements, advise management, and keep stakeholders informed on timelines and commitments to secure and maintain licenses in the Baltics. As part of the Baltic Regulatory team, you will collaborate across Baltic functions to provide regulatory intelligence, business compliance, and strategic guidance.
Responsibilities
- Operational Regulatory Brand Management:
- Fulfils all vital regulatory tasks for launching new centrally approved products and collaborates with the commercial teams, global regulatory affairs, quality, and AZ operations.
- Prepares all regulatory life-cycle-management tasks for approved products (centrally approved products, mutual recognition, and nationally approved products)
- Leads the local implementation of packaging material due to variations, considering the required grace period and the operational strategy on production
- Provides the regulatory information to the local supplying partner for releasing products to the Latvian market
- Deals with the notification process of out-of-stock situations to the Health Authority in collaboration with Market Access, Supply Chain, and quality functions
- Applies for an import license according to local requirements
- Supports the business in regard to Compassionate Use and other Programs
- Guarantees regulatory compliance and quality assurance steps in the regulatory area
- Works cross-functional with local teams on planning and strategic regulatory input on launches and changes (variations) of registrations
- Ensures that all regulatory databases are used as required in AZ procedures. Acts as local recall administrator in the Latvian market.
- Represents AZ at the trade association level.
- Operational Nominated Signatory deputy:
- Act as the deputy Nominated Signature in Latvia.
- Support the adaptation of global procedures locally to meet the specific needs of the Baltic organization
- Sign-off of marketing material form and market ethical point of view.
- Ensures AZ practices/texts / other materials meet external requirements and AZ policies.
- Analysis of external trends and internal development within AZ related to market ethical rules and practices.
- Additional Strategic Regulatory Management:
- Prepares and maintains local regulatory procedures in consideration of the global and local requirements by defining the best way forward for the local and global processes
- Conducts research of local Health Authority and EMA/EC websites, interprets the local implementation, and updates the RA team/business on key requirements and changes
- Works closely with global/regional RA teams on policies on legal changes, and changes in processes
- Participates in global strategic regulatory projects via EU/Canada network
- Additional Strategic priorities for the Nominated Signatory deputy role:
- Business Partnering
- Simplification
- Training and coaching
- Decision making
- Understanding the complexity of medicine promotion regulations
- Capability Development:
- Health Authority Relationship Management
- Audits and Inspection Knowledge
- Business Relationship Management
- Agile Thinking
- Management and Use of Technology
- Change Enablement
- Lean Process Management and Continuous Improvement
- Skills/Experience:
- University degree in life sciences, pharmaceutical studies
- Minimum of 3 years proven work experience in a local regulatory affairs department
- Excellent command of English
- Native Latvian
- Experience with the innovative pharmaceutical industry will be considered beneficial