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
Cognizant is a leading IT Services provider globally, transforming Clients' business, operating and technology models for the digital era. Headquartered in the US, Cognizant is ranked on the Fortune 500 and is consistently listed among the most admired companies in the world.At Cognizant, we celebrate diversity and inclusion across our workforce and with our partners, communities and fellow racing fans. That’s why, alongside the Aston Martin Cognizant Formula One team, we work in unison for a more inclusive future. All in, all welcome.