Grindeks is the leading pharmaceutical manufacturer in Baltic States, headquarters in Riga, Latvia and operating since 1946. Grindeks Group consists of JSC Grindeks and its subsidiaries.
We are seeking a dedicated and experienced International Regulatory Affairs Specialist.
Your main responsibilities will involve:
- Registration of generic medicinal products in accordance with national regulations of Balkan region.
- Communication with state authorities during the registration process.
- Supervision and maintenance of up-to-date registration documentation in the post-registration period: variations, renewals.
- Responsibility for the transfer of registration (MAH transfer) within implementation timelines.
- Knowledge and orientation in eCTD format.
- Close cooperation with Headquarter company management, local persons, pharmacovigilance, quality, and logistics departments.
- Coordinate where applicable the translations for SmPC, product labeling, artwork and patient information.
- Establish and enhance relationships and interactions with Regulatory Authorities.
- Keep records and files of Regulatory activities and databases.
- Monitoring changes in legislation and regulations and ensuring their implementation in the company.
You will excel if you have:
- University Degree in Chemistry or Pharmacy. Advanced degree preferred.
- Minimum of 2 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth understanding of regional and global regulatory requirements for pharmaceuticals.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a team environment.
- Exceptional attention to detail and organizational skills.
- Ability to manage multiple projects and deadlines in a fast-paced environment.
- Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
What we offer:
- Unique opportunity to join the company in very exciting phase of business growth.
- Opportunity to improve the quality of life for people worldwide by providing them simple and innovative solutions that improve their health.
- Extensive motivation program.
- Dynamic work environment.
- Career development opportunities, professional as well as personal growth.
