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Regulatory Affairs Specialist

Biomapas

Information about the position

  • Place of work: Remote work
  • Basic wage component (gross) and other rewards: 2 000 - 3 000 EUR/monthDepends on work experience and skills; Annual bonus based on personal and Company performance achievement.
  • Contract type: full-time

Job description, responsibilities and duties

• Manage and facilitate all registration related activities mainly for SK and the other EU countries;
• Compile, coordinate and monitor applications for registration, renewals, variations in accordance to the national and EU legislation, standard operating procedures;
• Make regulatory monitoring of the current duties related with the particular product;
• Maintain contact with regulatory authorities client/sponsor representative;
• Provide the Regulatory team with regulatory input in order to obtain timely regulatory approvals for the products;
• Translate/update the specific product dossier documents, i.e. Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL), labeling etc. into Romanian or English language;
• Update and collect information on registration instructions and regulations.

Employee perks, benefits

In Biomapas you will find a supportive work environment with a guarantee for professional and personal development, as well as competitive salary and benefits and many more initiatives that will make your daily life comfortable.

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)

Educational Specialization

Medicine, Pharmacy, Life Sciences

Language skills

English - Proficiency (C2) and Slovak - Proficiency (C2)

Other knowledge

Microsoft Office - expert

Number of years of experience

Regulatory Affairs in international environment
2

Personality requirements and skills

• Experience with medical devices and marketing material review is an advantage;
• Excellent knowledge of English (Russian would be considered a big advantage);
• Decision making skills;
• Careful planning to achieve accurate and timely results;
• Recognize recurring issues and analyze their causes in order to reach a solution

Advertiser

Brief description of the company

Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs and Pharmacovigilance. The company has a significant presence across the CEE, Nordic and CIS countries thereby offering fast and reliable patient recruitment for Phase I-IV and medical device clinical trials, while regulatory and pharmacovigilance services are provided across 5 continents.

Number of employees

150-199 employees

Company address

Biomapas
109 Savanoriu ave.
LT-44208 Kaunas
Lithuania
https://biomapas.com