Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Specialist role will make an impact.
Key responsibilities for this role include:
- Ensure regulatory compliance and maintenance of all product registrations and licenses throughout the whole life-cycle of the medicinal products (authorized via NP, MRP, DCP or CP).
- Тimely organization and preparation of new version of all packaging materials.
- Ensure translation and quality check of product information.
- Ensure that regulatory submissions and other deliverables meet strict deadlines and fulfill European regulatory standards.
- Ensure implementation of agreed urgent safety measures and additional risk minimization measures, secure HA approval and support distribution in collaboration with relevant affiliate departments.
- Support in the provision of expert regulatory input to strategic decision-making.
- Provide regulatory support on day-to-day regulatory issues, new initiatives and developments, including training to internal stakeholders and support to the local and regional regulatory teams.
- Maintenance of company regulatory databases.
- Review promotional materials and approve those from regulatory point of view.
- Keep up-to-date with changes in regulatory legislation and guidelines.
- Timely respond to inquiries and requests coming from the regulatory bodies.
The minimum qualifications for this role are:
- University degree, preferably in Medicine, Pharmacy, Chemistry/Biology/Chemical Engineering;
- Minimum 2 years of professional experience on a similar role;
- Thorough knowledge of the job-related Bulgarian and European regulatory procedures;
- Ability to handle multiple priorities simultaneously;
- Outgoing personality to ensure easy communication and liaison with officials;
- Strong interpersonal and leadership skills;
- Fluent in English (written and verbal);
- Proficiency in MS Word, MS Excel and MS PowerPoint.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
We’re always looking for people who want to make a difference. If you’re interested in joining our remarkable team, apply for this role.
Application link: https://www.jobs.bg/job/6714010