Regulatory Affairs Manager and Nominated Signatory

Introduction to role

Join us as a Regulatory Affairs Manager and Nominated Signatory to be responsible for the regulatory process in Estonia's assigned therapeutic areas. In our complex regulatory environment, your key role will be to protect AZ's reputation and make ethical decisions that support external activities. You'll ensure compliance with regulatory agencies and act as an advisor to management, keeping stakeholders informed on timelines and regulatory commitments to secure licenses in the Baltics. As part of the Baltic Regulatory team, you'll collaborate with Baltic teams, offering regulatory intelligence, business compliance, and strategic guidance.

Accountabilities

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 national 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 Estonian 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 import license according to local requirements

• Supports the business in regards of Compassionate Use and Named Patient use Programs as well by preparing the CUP dossier for submission to the Health Authority

• 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 Estonian market.

• Represents AZ at trade association level.

Operational Nominated Signatory:

• Act as lead Nominated Signature in Estonia.

• Support the adaptation of global procedures 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 practice.

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 on processes

• Participates in global strategic regulatory projects

Additional Strategic priorities for Nominated Signatory role:

• Business Partnering

• Simplification

• Training and coaching

• Decision making

• Understanding the complexity of medicines 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 or any other university degree

• Minimum of 2 years proven work experience in a local regulatory affairs department

• Excellent command in English

• Fluent Estonian

• Experience with innovative pharmaceutical industry will be considered beneficial

At AstraZeneca, you will play a critical role in impacting patients in need. Our science-led enterprise drives fast approvals to get the right medicines to the right patients faster than ever before. Being part of AstraZeneca means contributing to our growth and delivering life-changing medicines to patients with unmet medical needs. We value innovation, creativity, and collaboration, empowering our team to lead breakthroughs and shape drug development strategies.

Ready to make a difference? Apply now!