(INACTIVE) - LICE ODGOVORNO ZA REGULATIVA

• Medicine and health
• Skopje
• komak medikal dooel
• 17-09-2022

Job details

Great job opportunity for a REGULATORY AFFAIRS ASSISTANT for one of the most reputable, full-service providers of CRO and SMO, established in 1997, 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.

 

What is required for the role?

 

- Graduate or postgraduate degree

- Working knowledge of current ICH/GCP guidelines, applicable regulations (including country 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

- Positive attitude and ability to interact with all levels of staff- Ability to work under pressure and to keep tight deadlines

- Proficiency in English;

- Working knowledge of Word, Excel, and Power Point

 

What is expected to be done?

 

- Establish study regulatory strategy with client and project team;

- Discuss and agree the submission timelines 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 SOP in close collaboration with the study team;

- Assist in resolving issues related to submission process and requirements;

Initiate and participate in internal discussions for 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 determination of regulatory strategy/expectations and - parameters for submissions and all necessary authorizations, as requested;

- Support Global Regulatory Affairs Manager in implementation of the regulatory changes;

- Support the Global Regulatory Affairs Manager in developing a strategy for ensuring regulatory intelligence, as needed;

 

Why to join Comac Medical?

 

- Great team of knowledgeable, high-achieving and experienced professionals

- International and diverse work atmosphere

- Challenging projects in a different therapeutic area as well as in early phases

- Opportunity to enrich professional skills and progress in career development

- Competitive remuneration

- Additional health insurance and food vouchers

- 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 to send your detailed resume in English at both emails: bojana.dzurovska@comac-medical.com and gjoko.todorovski@comac-medical.com

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