Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a full-service providers of CRO and SMO with headquarter in Sofia, Bulgaria.
Regional Regulatory Leader
What is expected to be done?
- Establish study regulatory strategy with the client and project team;
- Discuss and agree on the submission timelines for all countries in the region with the Project Leader and the client;
- Perform quality checks of clinical trial documentation prior to EC and RA submission as per the local requirements and applicable SOPs in close collaboration with the study team;
- Assist in resolving issues related to regulatory activities and requirements;
- Initiate and participate in internal discussions for any regulatory requirements and issues;
- Review project documents for regulatory completeness, consistency, and accuracy, and interact with project team members to assure completeness, as necessary;
- Serve as Project Regulatory Lead and/or Regulatory Affairs Specialist;
- Support Global Regulatory Affairs Manager in the maintenance of regulatory intelligence for all countries within the assigned region;
- Support Global Regulatory Affairs Manager in the implementation of the regulatory changes in the assigned region;
- Support the Global Regulatory Affairs Manager in preparations for interactions with HAs and assist operating teams with these interactions;
- Support the Global Regulatory Affairs Manager when needed to serve as the Regulatory representative on specific cross-functional teams and provide regulatory viewpoints and expertise to them (e.g.: Scientific team, Bioanalytical team etc.).
What is required for the role?
- Graduate or postgraduate degree;
- At least 3-years’ experience in the field of clinical trials and at least 2 years as a Regulatory Specialist/ Regulatory Affairs Associate;
- Working knowledge of current ICH/GCP guidelines, applicable regulations (including regional-specific ones), and current industry practices;
- Excellent organizational, communication (verbal and written) and interpersonal skills;
- Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings;
- Proficiency in English;
- Positive attitude and ability to interact with all levels of staff;
- Ability to keep tight deadlines and work in a demanding environment;
- Working knowledge of Word, Excel, and PowerPoint.
Why join Comac Medical?
- Great team of knowledgeable, high-achieving, and experienced professionals;
- International and diverse work environment;
- Challenging projects in a different therapeutic area as well as in early phases;
- Competitive remuneration;
- Additional health insurance, food vouchers and subsidized Multisport card;
- You will receive and will participate in a number of training to enrich your professional knowledge.
Core strengths of Comac Medical:
- Proven track record for quality and delivery;
- Established and trusted relationships with KOLs;
- Motivated, capable and dedicated team;
- Global full-service capabilities.