Regulatory Affairs Associate
Location: Belgium, Brussels
Schedule: Part Time - Office based
TalentSource Life Sciences, a division of CROMSOURCE, is currently looking for a Regulatory Affairs Associate (CMC) to strengthen the team of one of our TOP Pharmaceutical client Companies. An operational role where you will be responsible to coordinate all steps of the registration process on an international level for a number of countries. You will be responsible for the execution of CMC strategies, submissions and compliance activities for biopharmaceutical projects/products from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD's, MAA's…) to regulatory agencies. If you have the experience, you may also act as CMC liaison with regulatory authorities.
- Leads the preparation of CMC information for submission to regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans
- Ensures that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements
- Support preparation of interfaces with Boards of Health, including scientific reviewers, administrative staff, in order to discuss and define regulatory applications (Quality Module, Responses and Commitments
- Depending on experience, may act as CMC representative in formal meetings and teleconferences with regulatory authorities
Education and Experience:
- University degree, Scientific (minimum PharmD or science related BSc or MSc)
- Experienced in regulatory CMC or within pharmaceutical development or manufacturing
- 3-5 years prior international regulatory with experience in CMC or in Quality Assurance
- Good understanding of drug development/commercial manufacturing of biopharmaceuticals
- Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation
- Leadership skills, influencing and persuading skills
- Excellent cross-cultural awareness and understanding
- Fluency in the English Language is essential
- Excellent communication, interpersonal and relationship building skills
- Collaborative team player
- Excellent planning, organizational and project management skills
- Proactive and flexible
Who will you be working for?
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.
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.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002243
or please contact Rocio.EgeaMota@cromsource.com for more information.
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.
Keywords: Regulatory Affairs Associate
Skills: CMC, MS Office, Quality Assurance, Regulatory, Regulatory submissions Location: Belgium, Brussels Share:
LinkedIn Facebook Twitter Email