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BiomapasBI

(Senior) Regulatory Affairs Specialist Latvia

Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs, Pharmacovigilance, and Medical Information.

Biomapas

Employee count: 201-500

Latvia only

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Join our global team as a (Senior) Regulatory Affairs Specialist.

(Senior) Regulatory Affairs Specialist is responsible for assigned projects and related tasks, supporting local marketing authorization and post-authorization activities, as well as coordinating regulatory activities in other markets, when required.

Position is full-time remote/home-based in Latvia.

Responsibilities:

  • Act as Local Regulatory Affairs Specialist in Latvia.
  • Manage registration and post-registration related activities mainly for Medicinal Products (NP, MRP/DCP, CP), as well as providing support for Medical Devices, including, local documents preparation, translation, notification etc.
  • Maintain timely and effective communication with Local Competent Authorities and client representatives.
  • Regulatory review for AWs, promotional materials, and product information to ensure full compliance with applicable regulatory requirements.
  • Translate/update the specific product dossier documents.
  • Work according to the standard operating procedures provided by Biomapas/Client, follow updates and participate in the training.
  • Ensure timely reporting and updating of regulatory data within Client systems.
  • Support Biomapas Clients with other RA related tasks, including strategic and operational regulatory advice.

Requirements

  • University degree in Life Science field
  • Fluent English language and Latvian language
  • 4- 5 years of experience in Regulatory Affairs with medicinal products
  • Experience in Regulatory Affairs with Medical Devices
  • Experience with food supplements and cosmetics is advantage
  • Time management skills
  • Ability to solve problems and make decisions

Benefits

  • Professional growth and career opportunities
  • International team and environment
  • Bonus based on annual performance
  • Personal accident and business trip insurance
  • Additional health insurance
  • Remote/home based position with possible visits to HQ
  • Rewarding referral policy
  • Workplace establishment allowance

About the job

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Posted on

Job type

Full Time

Experience level

Senior

Location requirements

Hiring timezones

Latvia +/- 0 hours

About Biomapas

Learn more about Biomapas and their company culture.

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Biomapas embarked on its journey in 2001, establishing its roots in Lithuania with a clear vision: to become a pivotal partner for the global life science industry. What began as a focused endeavor to provide clinical research services in the Baltics quickly evolved. By 2002, the company launched its Phase I-IV clinical research services, marking its formal entry into supporting drug development. The subsequent year, 2003, saw Biomapas conduct its first clinical trial in Belarus, signaling an early ambition for broader regional engagement. This expansion continued, and by 2004, Biomapas was already involved in clinical trials with biological and biosimilar products, showcasing its adaptability to the evolving pharmaceutical landscape.

The company's service portfolio broadened significantly in 2005 with the introduction of full-scope pharmacovigilance services, a critical component in ensuring drug safety post-market. Recognizing the increasing complexity of drug approval processes, Biomapas launched its regulatory affairs services in 2009, further solidifying its role as a comprehensive solutions provider. A commitment to quality and standardized processes was underscored in 2012 with the achievement of ISO 9001:2008 certification. Over the years, Biomapas has consistently expanded its geographical reach and service capabilities, now operating in over 60 countries across Europe, the CIS region, MENA, and EAEU. This growth has been driven by a dedication to combining global standards with local expertise, leveraging technology for efficiency, and fostering senior-level partnerships. Today, Biomapas stands as a functional and full outsourcing solution provider, offering expertise in clinical trials, regulatory affairs, pharmacovigilance, and medical information, always aiming to advance clinical development and ultimately improve patient health worldwide.

Employee benefits

Learn about the employee benefits and perks provided at Biomapas.

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Competitive salary and benefits

Offers competitive salary and benefits.

Work-life balance initiatives

Many initiatives that will make your daily office life comfortable and support work-life balance.

International environment

Colleagues from more than 15 countries allow us to develop ourselves professionally and personally.

Professional and personal development

Guarantee for professional and personal development, including Biomapas academy and Leadership academy.

View Biomapas's employee benefits
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Biomapas

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Biomapas hiring (Senior) Regulatory Affairs Specialist Latvia • Remote (Work from Home) | Himalayas