Regulatory Affairs Associate

Company Description

At SGS, you can choose!

First of all, out of our various vacancies.
However, SGS also gives you another choice.
Do you choose to expand or to enrich? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can connect our diversity to our services. To each other. And this way, enrich our business.

SGS is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to almost 100 000 colleagues worldwide, with more than 1650 employees in Belgium only. Our employees give 110% of themselves every day, divided over all expertises, branches and cultures. Our coworkers build their own way inside the company, the services and the expertise.

SGS Life Sciences carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities.
SGS Life Sciences has also expertise in the quality control of pharmaceuticals.

In the spirit of continued growth and to help improve our business, we currently have an opportunity for a Regulatory Affairs Associate (Mechelen)

Job Description

Your challenge will be to:

· provide advice and/or assistance related to the request of Scientific Advice and other Agency meetings
· provide advice and/or assistance related to the development of a Pediatric Investigation Plan
· provide advice and/or assistance on the development of Clinical Development Plans
· coordinate the preparation, review and receipt of all required regulatory documentation related to clinical trials in close cooperation with Sponsor and study team.
· coordinate compilation, submission and follow-up on clinical trial applications.
· liaise with Competent Authorities and provide responses to questions on clinical trial applications.
· keep Sponsor and other relevant internal parties informed on regulatory submission and approval status in different countries involved in the clinical trial.
· complete public trial registries where / if applicable
· gather information about the country specific regulatory requirements using different sources (contact with the regulatory authorities, internet, regulatory consultant, …).
· provide advice to Sponsor on local regulatory requirements and submission strategies to be followed
· write / review of Investigator’s Brochures
· write / review of Investigational Medicinal Product Dossiers and other CMC documents.

Qualifications

What do you need to be successful?

You have obtained a master’s degree in life sciences and have at least 3 years of RA experience in the pharmaceutical/CRO industry.
You have a good knowledge of EU regulatory procedures.
You have good organizational skills, proven ability to multi-task and excellent written and verbal communication skills in English. Other languages are an asset!
You can demonstrate the ability to coordinate tasks with others for timely completion and to avoid setbacks.

Additional Information

What we have to offer:

Were you already considering a switch or new step in your career?

Maybe this could be the one!

At SGS you can count on an interesting position where you can take responsibility.

We work towards your professional growth and will support you during your career development path.
A good work-life balance.

Come enjoy our team of colleagues and take your chance to be part of a great and dedicated team!

Do you want to be part of this?

We are looking forward to hearing from you!

Send us your story and your resume via the apply button and maybe you will soon join us for work and coffee breaks.

Still have questions? Heidi Aerts can give you more details about the job.
Send her an e-mail at [email protected]