Senior Regulatory Affairs Specialist
2800-3800 €/mon.
gross
Данные калькулятора CVbankas.lt.
Full-time
Kaunas
- UAB „Insuvia“
About Insuvia and the role offered:
Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services.
We are looking for a Senior Regulatory Affairs Specialist in Lithuania.
We are looking for a Senior Regulatory Affairs Specialist in Lithuania.
Your primary responsibilities will include:
- Manage Regulatory Affairs related activities in Lithuania and EU.
- Lead, oversee and coordinate regulatory affairs activities in other countries of scope in cooperation with colleagues based locally in those countries.
- Manages key client accounts and acts as a Project Coordinator for complex projects.
- Serve as the main contact point and expert for regulatory affairs for internal and external stakeholders, provide consultations and advice to customers and internal team on local regulatory requirements.
- Advice and support the preparation and submission of regulatory applications, including but not limited to new marketing authorization (MA) applications, variations and renewals, MA transfers, and subsequent correspondence with the regulatory authorities.
- Compile and/or maintain regulatory documentation databases/systems, track life-cycle submissions.
- Communicate with regulatory authorities regarding pre-submission strategies, potential regulatory pathways, compliance requirements, follow-up on submissions under review/evaluation.
- Translate/revise product information (package leaflet / summary of product characteristics).
- Validate artworks in line with the marketing authorization and local legislation.
- Review of promotional materials for regulatory compliance.
- Monitor regulatory duties related with assigned product portfolio.
- Submit national declarations and notifications to regulatory authorities as required.
- Perform other regulatory affairs assistance as requested.
Required qualifications:
- Education in science/health discipline (e.g. Pharmacy, Medicine, Public Health or similar).
- Minimum of 3-year experience in in Regulatory Affairs.
- Fluent command of English (written and spoken).
- Proactive, self-motivated professional with a strong results-oriented mindset.
- Excellent problem-solving skills with the ability to make sound, timely decisions in complex situations.
- Demonstrated commitment to quality, regulatory compliance, operational excellence, and continuous improvement.
- Strong attention to detail, with the ability to manage multiple priorities and deliver high-quality outcomes in a fast-paced environment.
What we offer:
- Additional Vacation Days: After each year, employees are granted additional days off as a representation of appreciation for their dedication and loyalty to the company.
- Health and Wellness Benefits: Your well-being matters to us. We offer comprehensive health and wellness benefits to ensure your wellness.
- Free Parking: Employees also enjoy the perk of free parking in the city center, complementing the office's central location.
- Company Events and Team-Building Activities: We believe that building strong relationships is essential for a successful team. You'll have the chance to participate in various team-building activities and company events.
- Meaningful Work and Impact: Join a company where your contributions truly matter. You'll be part of projects that make a difference and positively impact our customers and the community.
What we offer:
Work life balance
Extra paid vacation Hybrid workHealth
Health insuranceSalary
2800-3800
€/mon.
gross
Work place
UAB „Insuvia“
Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services.
information about UAB „Insuvia“
3406 €
Avg. salary gross
(58% higher than LT average)
35
Number of employees
5-10 mln. €
Revenue 2025 y.
Distribution of employees by salary (before taxes):
25% earn up to
2785 €
25% earn
2785-3475 €
25% earn
3475-3998 €
25% earn more than
3998 €