About Company
Akciju sabiedrība “Olainfarm” is a leading Latvian pharmaceutical company with a rich history spanning over 50 years. We specialize in the research, development, manufacturing, and marketing of high-quality chemical-pharmaceutical products and active pharmaceutical ingredients. Our diverse portfolio includes prescription medicines, over-the-counter drugs, food supplements, and veterinary preparations, serving patients and healthcare professionals across more than 50 countries worldwide. Driven by a commitment to innovation, quality, and sustainable growth, Olainfarm continually invests in modern technologies and R&D to address unmet medical needs. We pride ourselves on fostering a collaborative and dynamic work environment where talented professionals can thrive, contributing to global health and well-being. Joining Olainfarm means becoming part of a team dedicated to making a tangible difference in people’s lives through science and compassion.
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Job Description
As a Regulatory Affairs Specialist at Akciju sabiedrība “Olainfarm”, you will be at the forefront of ensuring our pharmaceutical products meet the stringent requirements of national and international health authorities. This pivotal role involves navigating the intricate world of pharmaceutical regulations, from initial product development to post-market surveillance. You will be directly responsible for the preparation, compilation, and meticulous submission of regulatory dossiers, including new Marketing Authorization Applications, variations, and renewals, with a primary focus on the European Union market and various international territories. Your expert knowledge will be instrumental in interpreting complex regulatory guidelines, providing critical strategic advice to multi-disciplinary teams across R&D, Quality Assurance, Production, and Marketing, and serving as a key point of contact with regulatory bodies.
The successful candidate will demonstrate a comprehensive understanding of global pharmaceutical legislation, with particular emphasis on EU regulations such as EMA guidelines and specific national requirements within member states. You will proactively monitor and analyze the constantly evolving regulatory landscape, identifying potential impacts on our product portfolio and operational processes, and recommending proactive strategies. This role demands an exceptional eye for detail, robust analytical capabilities, and the resilience to perform effectively under tight deadlines in a dynamic environment. Your collaborative spirit will be key in integrating regulatory compliance seamlessly into every stage of the product lifecycle, fostering strong partnerships across departments to achieve our shared goals.
We are seeking a highly organized, proactive, and problem-solving individual capable of independently managing multiple regulatory projects simultaneously. Your ability to distill complex regulatory information into clear, actionable insights, both verbally and through written documentation, will be paramount. By upholding the highest standards of regulatory compliance, you will directly contribute to our mission of delivering safe, efficacious, and high-quality medicines to patients around the world. This is a significant opportunity to advance your career within a well-established and globally recognized pharmaceutical leader, where your contributions will have a tangible and meaningful impact on both company success and public health.
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Key Responsibilities
- Prepare, compile, and submit high-quality regulatory dossiers (e.g., Marketing Authorization Applications, variations, renewals) in eCTD format.
- Act as a primary contact point with national and European regulatory authorities, responding to queries and managing regulatory correspondence.
- Interpret and apply relevant pharmaceutical regulations, directives, and guidelines (e.g., EU GMP, ICH, EMA) to ensure product compliance.
- Provide expert regulatory advice and support to R&D, Quality Assurance, Production, and Marketing teams throughout the product lifecycle.
- Monitor and assess changes in the regulatory environment, communicating potential impacts to the business and recommending strategic adjustments.
- Participate in regulatory intelligence activities, staying updated on new legislation and best practices.
- Manage and maintain regulatory databases and documentation systems, ensuring accuracy and completeness.
- Support due diligence activities for new product acquisitions or partnerships from a regulatory perspective.
- Assist in the preparation and review of product information, labeling, and promotional materials to ensure regulatory compliance.
- Participate in internal and external audits as a regulatory expert.
Required Skills
- Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related scientific field.
- Minimum 3-5 years of experience in Regulatory Affairs within the pharmaceutical industry.
- In-depth knowledge of EU pharmaceutical legislation and regulatory procedures (MRP, DCP, CP, national procedures).
- Proven experience in preparing and submitting regulatory dossiers (e.g., eCTD).
- Excellent written and verbal communication skills in English.
- Strong analytical, problem-solving, and organizational skills.
- Ability to work independently and as part of a cross-functional team.
- Proficiency in Microsoft Office Suite and regulatory affairs software/databases.
Preferred Qualifications
- Fluency in Latvian (written and spoken) is a significant advantage.
- Experience with other international regulatory frameworks (e.g., CIS region, USA).
- Experience with biological products or medical devices.
- Professional certification in Regulatory Affairs (e.g., RAC).
- Proven track record of successful marketing authorization approvals.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health insurance package.
- Opportunities for professional development and continuous learning.
- Modern and stimulating work environment in a leading pharmaceutical company.
- Access to an employee wellness program.
- Team-building events and corporate social responsibility initiatives.
- Employee discounts on company products.
- Subsidized lunch options.
- Pension plan contributions.
How to Apply
Interested candidates are invited to submit their detailed CV and a compelling cover letter, outlining their relevant experience and motivation for this role. Please click on the application link below and navigate to our careers section to find this specific job posting and proceed with your submission. Ensure all required fields are completed accurately.
