Senior Regulatory Submissions Specialist

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do.  A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals.  We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.  

Learn more why you should join PSI here!

Job Description

Join our team of experts in regulatory submissions of clinical research studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in developing your professional career.

In this role you will:

• Develop submission strategies and plan study regulatory timelines
• Track changes/amendments to legislation requirements related to clinical research and maintain the database of regulatory requirements
• Prepare/Review clinical trial submission dossiers for Regulatory and Ethics Authorities
• Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
• Review translations of essential documents subject to clinical trial submission
• Track the regulatory project documentation flow
• Review documents to greenlight IP release to sites
• Manage safety reporting to authorities
• Deliver regulatory training to project teams
• Assess regulatory aspects of study feasibility, support PSI Business Development team in winning new studies for the region

Hybrid work with the office in Warsaw.

Qualifications

• College/University degree in Pharmacy, Medicine, Life Sciences, or an equivalent combination of education, training, and experience
• Prior and solid experience with clinical trial regulatory submissions in Poland, of minimum 2 years.
• Full working proficiency in English and Polish
• Proficiency in MS Office applications
• Detail-oriented
• Ability to learn, plan and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills

Additional Information

What we offer:

• We'll prepare you to do your job at highest quality level with our extensive onboarding 
• You'll have excellent working conditions - spacious and modern office in convenient location, and friendly, supportive team who love to hang out together 
• You'll have permanent work agreement at a stable, privately owned company
• We care about our employees - aside from competitive salary, you'll have good work-life balance with flexible working hours and additional days off, life and medical insurance, sports card, lunch card 
• We're constantly growing which means opportunities for personal and professional growth 

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Please provide your CV in English. 

If you have any questions, don't hesitate to reach out to the recruiter at patrycja.kal@psi-cro.com or on linkedin.com/in/patrycjakal