Regulatory Affairs Specialist
About the job
- A university degree in Pharmacy, Life Science, Medicine, or a related field is required.
- Fluent English and Ukrainian are required.
- Four to five years of Regulatory Affairs experience with medicinal products, medical devices, and food supplements are required.
- Excellent knowledge of the registration of medicinal products, medical devices, and food supplements according to national rules is required.
- Time-management skills are required.
- The ability to solve problems and make decisions is required.
- Prepare and maintain regulatory submissions, registrations, renewals, and variations for medicinal products and medical devices, and notifications for food supplements.
- Ensure products, labeling, packaging, and promotional materials comply with Ukrainian regulations.
- Monitor regulatory changes and assess their impact on the product portfolio.
- Liaise with regulatory authorities and external partners.
- Support product launches, lifecycle management activities, and compliance initiatives.
- Support pharmacovigilance activities, including submitting safety-related documentation to regulatory authorities.
- Coordinate implementation of safety-related labeling updates and variations.
- Collaborate with local and global pharmacovigilance teams on safety communications, regulatory commitments, and inspection readiness.
- Maintain regulatory documentation and databases.
- Manage vendors.
- Participate in audits.
About the company
Biomapas provides full outsourcing for the global life sciences sector, handling clinical research, regulatory submissions, and pharmacovigilance across biopharmaceuticals, medical devices, cosmetics, and dietary supplements. Its in-house team conducts studies and regulatory activities in high-recruiting countries and supports Europe, CIS, MENA, and LATAM from early development through commercialization. The approach is integrated and hands-on, with solutions tailored to client needs and delivered as part of the client team to address complex challenges efficiently. The company aims to help clients bring products to market on time and within budget by offering end-to-end, reliable services from a single partner.
Company Size
201-500
Company Stage
N/A
Total Funding
N/A
Headquarters
Kaunas, Lithuania
Founded
2001
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Simplify's Take
What believers are saying
- Biomapas named Xavier Duburcq CEO in February 2026 to execute expansion.
- Management targets a €200 million-plus diversified pharma-services platform under Carbyne support.
- Biomapas celebrated 25 years in July 2026, signaling durable client relationships and operating continuity.
What critics are saying
- Carbyne’s buy-and-build strategy depends on integrating Delta PV and future acquisitions by 2027.
- CRO and pharmacovigilance services face pricing pressure from larger global rivals.
- If platform scaling stalls, Biomapas remains a mid-market service business without acquisition-led growth.
What makes Biomapas unique
- Biomapas bundles clinical, pharmacovigilance, regulatory, medical information, and writing services.
- Carbyne calls Biomapas a majority-held 2024 Baltic platform for global expansion.
- Delta PV acquisition in August 2025 deepened Biomapas’ pharmacovigilance and digital capabilities.
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Benefits
Health Insurance
Remote Work Options
Wellness Program
Home Office Stipend
Performance Bonus
Employee Referral Bonus
Company Social Events
Company News
Biomapas acquires Pinnaxis, strengthening its pharmacovigilance technology expertise. Tuesday, October 06, 2026 Biomapas, a leading integrated life sciences services provider, announces the acquisition of Pinnaxis, a global pharmacovigilance technology and consulting company headquartered in Noida, India, specialising in safety system implementation and upgrades, data migration, system integration, validation, reporting and analytics, and managed services. The acquisition strengthens Biomapas' technology capability in drug safety, adding engineering and configuration expertise across the industry's principal safety platforms, including Veeva Safety Vault, Oracle Argus and ArisGlobal, alongside established working relationships with the safety database providers themselves. Pinnaxis also brings more than 100 technical experts and a portfolio of proprietary tools and accelerators developed for safety data migration, reporting and case intake automation. Pinnaxis will lead Biomapas' Consulting & Digital business unit, driving how Biomapas applies technology and innovation across its services, including greater use of automation and AI in everyday safety work. The acquisition also expands Biomapas' presence in the United States, where Pinnaxis has an established client base and an office in New Jersey, supporting the group's ambition to grow its North American business. Nishant Rana, Founder & CEO of Pinnaxis: "Joining Biomapas is a major strategic move for Pinnaxis, its team and its clients. Pharma Focus Asia has built a business with deep expertise in safety systems, and becoming part of a broader life sciences platform lets Pharma Focus Asia take that further, reaching clients across Europe and beyond and offering them more than technology alone. For its people, this opens new horizons, with the opportunity to contribute to an expanded range of offerings alongside colleagues with complementary expertise. Its shared commitment to quality and serving clients with integrity made Biomapas the right partner for Pharma Focus Asia." Xavier Duburcq, CEO of Biomapas, said: "Pinnaxis brings deep expertise in the technology behind drug safety, strengthening its ability to connect specialist services with the systems that support them. Together with its regulatory, safety and clinical teams, Pharma Focus Asia will help clients manage increasingly complex requirements across the product lifecycle, combining scientific expertise with technology. This acquisition advances its ambition to build an integrated, digitally enabled partner for regulatory, safety and product development. Pharma Focus Asia will bring Pinnaxis and Biomapas together as one company, with shared priorities and teams working across disciplines and countries to deliver the full breadth of its capabilities to clients. Pharma Focus Asia will build on the strengths of both businesses, maintaining the close client relationships and uncompromising quality standards Pharma Focus Asia share." Carbyne Equity Partners, majority shareholder of Biomapas, has backed the company since October 2024 with the ambition of building a global, integrated life sciences services platform. The acquisition of Pinnaxis follows that of Delta PV in 2025 and adds a dedicated technology capability to the group. About Biomapas Biomapas is an integrated life sciences services provider supporting pharmaceutical, biotechnology and medical device companies across the product lifecycle. The company delivers regulatory affairs, pharmacovigilance, quality assurance, medical information and clinical research services, combining global standards with local expertise and technology-driven efficiency. Biomapas has offices in Luxembourg, Lithuania, Georgia and Turkey, and teams in more than 30 countries. The company is certified to ISO 9001 and ISO 27001. About Pinnaxis Founded in 2018, Pinnaxis is a global management and technology consulting company focused exclusively on pharmacovigilance and drug safety. The company supports pharmaceutical companies and CROs with safety system implementation and upgrades, data migration, system integration, validation, reporting and analytics, and managed services, working across the major commercial safety platforms. Pinnaxis operates from offices in Noida (India), New Jersey (USA) and London (UK), and is certified to ISO 9001 and ISO 27001. About Carbyne Equity Partners Carbyne Equity Partners is a private equity firm investing in growing European businesses with strong market positions and a commitment to innovation. Its focus spans healthcare, nutrition and agricultural inputs, sectors where the firm leverages its extensive network of entrepreneurial investors. Working closely with management teams, Carbyne supports businesses in accelerating growth and strengthening long-term market leadership.
Biomapas Group is pleased to announce the appointment of David Passov, MBA, as its new Chief Executive Officer, effective 21st February 2025.