Senior Regulatory Submissions Specialist

1w1 week ago

PSI CRO

Warsaw, PL · Full-time · PLN 180,000 – PLN 300,000

About this role

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.

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. Take a step further in developing your professional career.

Work in a dynamic team environment with hybrid setup at the office in Warsaw. Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters. Benefit from a friendly, supportive team who love to hang out together.

Receive extensive onboarding to perform at the highest quality level. Enjoy permanent work agreement at a stable, privately owned company with opportunities for personal and professional growth. Maintain good work-life balance with flexible working hours and additional days off.

Requirements

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

Responsibilities

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

Benefits

Extensive onboarding to do your job at highest quality level
Spacious and modern office in convenient location with friendly, supportive team
Permanent work agreement at a stable, privately owned company
Flexible working hours and additional days off
Life and medical insurance, sports card, lunch card
Opportunities for personal and professional growth