Regulatory Affairs Specialist/Manager

Pracovní nabídka

We are excited to welcome a new colleague to our Regulatory Affairs team in Novatin, who will be based in our office in Prague.

We are an established pharmaceutical company with a growing portfolio of generic medicinal products. We are looking for an experienced

Regulatory Affairs Specialist/Manager

who will be responsible for global regulatory strategy, life-cycle management of our products in EU countries, as well as overseeing the local regulatory agenda in the Czech Republic.

Position responsibilities include:

• Developing and managing regulatory strategy for planned registration procedures (DCP/MRP) of generic molecules, including the reference country selection, ensuring DCP slots.
• Overseeing the registration of new medicinal products in accordance with European and national regulations for EU markets (CZ, SK, HR, MT, ES) in cooperation and supervision of local regulatory associates.
• Communicating with stakeholders during the registration process. Close cooperation with company management, local authorized persons, pharmacovigilance, quality, and logistics departments.
• Life-cycle management - Ensuring of up-to-date registration documentation in the post-registration period: variations, renewals.
• Preparing and updating high quality product information (common and local).
• Coordinating artwork creation and ensuring proper implementation in production site.
• Establishing and enhancing relationships and interactions with Regulatory Authorities, acting as the main local contact for regulatory matters in the Czech Republic and Malta.
• Maintaining regulatory records and databases.
• Monitoring legislative changes and ensuring their implementation in the company.

Requirements:

• University degree in pharmacy, chemistry, biology, or a related field.
• At least 3 years of experience in Regulatory Affairs in the pharmaceutical industry.
• Solid knowledge in pharmaceutical regulations and legislation. Ability to effectively communicate with regulatory authorities and address their requirements and queries.
• Experience in preparing parts and finalizing dossiers for regulatory submissions. Knowledge and orientation in eCTD format.
• Excellent communication and organizational skills.
• Focused on detail, ability to work independently and within a team.
• Proactive problem-solving approach, pleasant and non-confrontational demeanor.
• Active knowledge of English, both spoken and written. Czech language for communication with SÚKL.

We Offer:

• Competitive salary and benefits (notebook, cell phone).
• Opportunities for professional growth and further education.
• Friendly and supportive work environment.
• Flexible working hours and the possibility of partial remote work.
• Opportunity to work on interesting and innovative projects.

If this opportunity resonates with you, please send us your CV together with a brief motivation letter. If your profile matches our expectations, we will contact you for an initial call or meeting to clarify key aspects of the role. Successful candidates will then be invited to a meeting with our representatives.

We look forward to hearing from you!

Eva Poláková

HR Manager