CMC Regulatory Affairs

仕事内容

Location: Antwerp area, Belgium - Office based
Schedule: Full Time, Contract or Freelance

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it’s the best of both worlds….

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a CMC Regulatory Affairs Specialist to join one of our clients, one of the most innovative pharmaceutical company in the world.

CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:
The primary responsibility is to support the post-approval CMC regulatory activities related to small molecules in all global markets.

Main Job Tasks and Responsibilities:
Collecting country specific requirements for post-approval variations
License renewals
Updating and maintaining data in regulatory systems
Coordinating health authority responses

Education and Experience:
CMC regulatory experience with post approval variation dossiers for small molecules worldwide preferred
2-4 years’ experience in Regulatory Affairs
Knowledge of global/worldwide regulatory guidelines and regulations is preferred

Skills:
Ability to understand and interpret scientific data
Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required
Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential
Strong attention to detail and organization skills

The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About CROMSOURCE
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Job Types: Full-time, Temporary contract, Freelance

Schedule:

• Monday to Friday