Regulatory Compliance Expert

Our customer is a leading producer and distributor of health related products. Their business model is vertically integrated running through the whole value chain. It is present in 40+ countries, in Europe and Asia and their strategic plan focuses on further market expansion.
Currently, we are looking to recruit a Regulatory Compliance Expert who will coordinate and oversee the successful registration of different medicines and medical devices on assigned markets.

He/she will contribute to the company's mission by excellent coordination of the initial registration and following amendments. Will be the single point of contact for different regulatory bodies.

Location: Sofia

Key responsibilities:

- Researches, analyzes and documents regulatory requirements for registration of medicines, food supplements and medical devices in a set of countries
- Maintains the knowledge together with relevant classifications, categorizations of national and international legislation and ongoing regulatory amendments for medicines, food additives and medical devices
- Prepares and compiles all relevant registration documentations files
- Proactively coordinates the regulatory actions, application forms, processes and deadlines with the commercial and other units of the company
- Contacts and coordinate the work flow with local offices and Authorities
- Collects, reviews and prepares electronic registration documents as per the relevant country regulatory requirements including application form, dossier, certificates, samples and etc.
- Initiates and manages all activities related to legalization and official translation of all the documents
- Responsible for timely responses to requests from regulatory bodies
- Proactively communicates with all internal units regarding regulatory status of the products and document distribution.
- Timely update of the information in the document management system.

Requirements:

- To be successful in this role you need to meet the following key requirements:
- University degree in natural sciences (biology, chemistry, pharma and etc)
- 3+ years’ experience in registration of pharma products on different markets/countries
- Pharmaceutical product and industry acumen
- Excellent knowledge about regulatory requirements and processes
- Fluent in written and verbal English
- Excellent reading in Russian and good writing and speaking
- Proactive and follow-through attitude
- High standard of work and willingness to meet and exceed expectations
- Proactively help staff and maintain a ‘can do’ attitude when under pressure
- Passion and enthusiasm for the role and the company
- Outstanding organizational and prioritization skills
- Excellent business communication skill and presence
- Goals and deadlines oriented person
- Computer literacy, experience and knowledge of working with Document Management System
- Ready for occasional travels

The company offers:
- Opportunity to join a leading international business
- An interesting, challenging job in a highly motivated and friendly team
- Freedom to fully bring in your individual strengths and skills
- Excellent work conditions
- Attractive compensation package

Skill Force activities are based on a Recruitment license №2289
If interested apply here: https://www.jobs.bg/job/5952771