Regulatory Affairs Sr. Associate, Nordics

Regulatory Sr. Associate, Nordics

We have an exciting opportunity to join our Nordic Regulatory Affairs team. This role encompasses a broad range of regulatory activities across the Nordic countries and can be tailored based on your prior experience and interests.

Do you thrive on teamwork, responsibility, and getting results? Do you want to work with innovative products? Are you proactive, have a high-quality attitude, and a genuine desire to contribute and grow within regulatory affairs? If yes, the position as Sr. Regulatory Affairs Associate, Nordics at Eli Lilly Sweden might be what you are looking for.

You will be part of an engaged and friendly Nordic team with colleagues across the Nordic countries. Our team focuses on inclusion, collaboration, and delivering results.

Your primary responsibilities will be affiliate regulatory affairs activities for Sweden and Norway as well as initiating and coordinating printing packaging material development and revisions for the Nordic countries

You will work in an exciting international and cross-functional environment, closely collaborating both face-to-face and virtually with colleagues across the global organization and Nordic affiliates to ensure regulatory excellence, compliance, and safety of our products for patients.

The role is based in our office in Solna, Sweden, and reports to the Head of Regulatory Affairs and Patient Safety, Nordics. We offer a flexible working environment.

Key Responsibilities:

• Support Global Regulatory Affairs applications to obtain and maintain marketing authorizations in the EEA via the Centralized and Mutual Recognition Procedures.

• Ensure that national Product Information aligns with local regulatory requirements and global labeling procedures, and that updated Product Information is translated, submitted, approved, and implemented within the designated timelines.

• Create, update, and approve printed packaging materials in collaboration with your regulatory colleagues in the Nordic countries for shared Nordics packs.

• Communicate relevant regulatory information to internal stakeholders.

• Represent the team and function in the Nordic and local Brand Teams.

• Lead and perform activities related to Risk Minimization Plans.

• Attend appropriate external symposia and conferences to develop and sustain an appropriate level of professional expertise.

• Ensure appropriate monitoring, interpretation, and implementation of relevant national legislation and regulations.

• Strive for inspection and audit-readiness and participate in aligned affiliate inspections, audits, and assessments.

• Keep data in relevant tracking systems up-to-date and accurate.

• If you have prior pharmacovigilance experience and/or wish to explore this area, local pharmacovigilance intelligence responsibilities such as trade organisation meetings and monitor local PV legislation and best practises can be included in the role.

Required Qualifications:

• Master’s degree in pharmaceutical or other relevant science or health care related field.

• Relevant prior experience from an affiliate regulatory affairs role working with the EU Centralized and Mutual Recognition procedures. Experience from a Regulatory role covering both Sweden and Norway will be an advantage.

• Fluent in either Swedish or Norwegian (written and spoken), including professional knowledge of medical terminology.

• Professional knowledge of English, including medical terminology.

About You and Your Skills:

• You enjoy working in a team and have tight-knit collaboration skills.

• You appreciate diversity and actively contribute to a working environment of trust and mutual respect.

• You work effectively in a virtual setting with colleagues in other countries.

• You work independently, are dedicated, and proactive.

• You prioritize and allocate time efficiently to meet deadlines.

• You are well-organized and structured with attention to detail.

• You handle complex situations through problem-solving and critical thinking.

• You have the flexibility to adjust to altered priorities.

• You have good relevant IT skills and a positive and curious approach to new technologies.

• You thrive in a flexible working environment, balancing office presence and working from home.