Regulatory Affairs Product Specialist

Theramex Warsaw Mazowieckie Poland (Hybrid)

You are expected to be a Regulatory Affairs Professional with some work experience in Regulatory Affairs/Pharmaceutical industry (minimum 1 year and preferably with an understanding of CMC documentation/Module 3). It is expected that you will be eager to learn have good interpersonal skills and problemsolving capabilities and be able to work on several issues within matrix environment. You will also be able to demonstrate excellent attention to detail and be fluent in English (both written and spoken).

About you:

You have a degree in Pharmacy Biology Chemistry or related disciplines with some work experience in Regulatory Affairs or Pharmaceutical industry. You have some understanding of National and European procedures in DCP MRP and Centralised Procedure and you are keen to learn new things.

About the role:

We are looking for a (Junior) Regulatory Affairs Product Specialist located in Poland to work in the Global Regulatory Affairs team supporting activities in European and international markets. You will provide regulatory support related to the designated products and help implement regulatory strategy with support and supervision from other team members.

Main accountabilities include:

• Preparation and submission of required regulatory packages for designated products/countries including variations and lifecycle activities
• Working with regulatory documentation including CTD/eCTD components and review of other technical documents to ensure regulatory compliance
• Provide support and regulatory advice to key internal stakeholders including Quality Pharmacovigilance and Manufacturing teams
• Communication with external stakeholders including regulatory agencies CMOs and thirdparty service providers
• Identify any gaps in the regulatory documentation and conduct any remediation necessary to achieve compliance with support of other team members
• Creation of Regulatory Information Management system records and entries

Theramex is a company dedicated to womens health across key times in their lives. We work with Passion Agility Collaboration and Integrity. This means:

• We are committed in heart and mind to improving care in Womens Health. We strive for absolute excellence in whatever we do.
• We are efficient nimble and flexible; our combined professional experience means we can not only make quick decisions but the right ones.
• Holding ourselves to the highest ethical principles is at the center of our philosophy. We are genuine and transparent and treat every individual with fairness and respect.
• We are dedicated to listening to our patients healthcare professionals and our employees. We appreciate the value of hearing from people who offer new ideas and innovation and working with them to improve and add to our offerings