RA Submission & Operations Senior Associate

One of our clients from the pharmaceutical industry is building a new hub in Warsaw and is looking for talented professionals, that would contribute to its success by joining the new team.

We are looking for a RA Submission & Operations Senior Associate that would be responsible for performing a diverse array of tasks to support the various teams within the Regulatory Affairs Department, aligning with business needs.

During periods of high demand, they provide enhanced support to the Regulatory Affairs teams in both administrative and specialized tasks.

Hybrid model: 3 days office-based, 2 days home-office

Main responsibilities:

Including but not limited to:

• Ensuring timely published and submitted eCTD sequences to the Authorities.
• Proofreading of documents regarding safety and quality variations.
• Being involved in approvals, variations, withdrawals, Change Controls, Regulatory Compliance Files, and various administrative tasks.
• Assuming trainer roles in one or more areas of the department’s responsibilities, ensuring knowledge transfer and skill development.
• Serving as superusers for systems such as the Veeva RIM Suite and EXTEDO eCTD Manager, among others.

Requirements:

• Demonstrates advanced abilities in interacting with a wide range of stakeholders, both internally and externally.
• Is service minded and holds a high degree of co-ordinational skills.
• Possesses a solid understanding of the pharmaceutical industry and general knowledge of Regulatory Affairs.
• Capable of working with a high degree of independence and proficient in managing associate tasks autonomously.
• Is proficient in both written and verbal English.
• Shows a general aptitude for IT.
• Professional training or experience within healthcare is considered an asset.

What you'll get in return

• Career in an organization with Scandinavian culture and values: Experience a work environment that emphasizes equality, work-life balance, and sustainability.
• Work in a hybrid model (3 days in the office per week)
• Potential for a permanent contract after an initial 3-month period.
• Comprehensive medical coverage through Medicover.
• Sports Card: Access to various sports facilities and activities.
• Life insurance coverage for added security.
• Opportunity to be involved in the transition of processes.
• Attractive and competitive salary.

Hays Poland sp. z o.o. jest agencją zatrudnienia zarejestrowaną w rejestrze prowadzonym przez Marszałka Województwa Mazowieckiego pod numerem 361.