Regulatory Affairs Lead

Great job opportunity for a Regulatory Affairs Lead  for one of the most reputable, full-service providers of CRO and SMO.

 Established in, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

 Currently we are looking for a proven professional to join our team.

What is expected to be done?

• Establish study regulatory strategy with client and project team
• Discuss and agree the submission timelines for all countries in the region with the Project Leader and the client
• Perform quality check 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
• When required, communicate and submit study documentation to Regulatory Authorities and Ethics Committees and follow-up on any requests, comments and/ or issues
• Initiate and participate in internal discussions for any regulatory requirements and issues.
• Reviews project documents for regulatory completeness, consistency and accuracy, interacts with project team members to assure completeness, as necessary
• Support Global Regulatory Affairs Manager in maintenance of regulatory intelligence for all countries within the assigned region
• Support Global Regulatory Affairs Manager in implementation of the regulatory changes in the assigned region or as directed
• Support the Global Regulatory Affairs Manager in preparations for interactions with HAs and assist operating teams with these interactions
• Support Global Regulatory Affairs Manager in collecting and review of monthly departmental KPIs for the assigned region

• Develop, mentor, manage and coach regulatory staff to progress their skills so that Comac Medical quality standards are maintained
• Promote company reputation across the employees

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 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 work under pressure and to keep tight deadlines.
• Working knowledge of Word, Excel, and Power Point.

Why to join Comac Medical?

• Great team of knowledgeable, high-achieving and experienced professionals;
• International and diverse work atmosphere;
• Challenging projects in a different therapeutical area as well as in early phases;
• Opportunity to enrich professional skills and progress in career development;
• Competitive remuneration;
• Professional trainings;

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;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.