Regional Regulatory Leader

• 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.).

• 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.