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Join our team in Gdansk! Reporting directly to the Delivery Site Lead you will lead and mentor a team of regulatory affairs specialists and use your expertise to represent regulatory matters. This function is within Submission Delivery group responsible for providing a wide scope of regulatory submissions to client’s affiliates worldwide (including EU and US).

• Developing and mentoring associates by providing expertise in all submission types applicable to their area of responsibility
• Leading team of publishers (Sr. and Jr. Levels), managing people
• Coordinating and triaging all submission related work activities
• Providing input into client processes and software to Engagement Manager for communication back to client
• Communicating issues and concerns to Delivery Site Lead proactively
• Quality Control of work through spot checks on a regular basis
• Understanding of client expectations
• Main point of contact for customer’s local affiliates
• Providing support to other regulatory related activities as per the business requirements
• Responsible for the completeness of project documents within the managed group including

• Science, computer science or engineering degree
• Minimum 3 years of experience in the pharmaceutical / Medical Device / any related industry, with relevant experience in electronic submission publishing, dossier management and dispatch of regulatory dossiers (US, EU, Asia, Latin America etc.)

• Excellent Regulatory Affairs knowledge (incl. different submission procedures)
• Experience in Regulatory Affairs in Pharmaceutical/ biological/ Chemical Products and/or Medical Devices
• Knowledge of regulatory IT systems and regulatory publishing tools
• Excellent people management and organizational skills
• Self-motivated
• Achievement building orientation
• Relationship building
• Inclination towards being process driven
• Going out of way to satisfy the external customer
• Punctuality (self-discipline)