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).
Your main goal is to create and sustain a great Team and some of your duties will include:
- 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)
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Poznaj
Cognizant Technology Solutions Poland Sp. z o.o.
COGNIZANT TECHNOLOGY SOLUTIONS POLAND SP Z O O
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