Regulatory Affairs Specialist

Contenido de trabajo

We are growing, grow with us!

Are you looking for a dynamic company with daily new challenges and opportunities?

Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

Regulatory Affairs Specialist

Your Job

• Obtain & maintain perfect knowledge of applicable legislation
• Stay up to date with scientific developments relevant for the portfolio of the clients.
• Preparation of regulatory dossiers while ensuring that the dossiers are processed in accordance with the regulations in force and in compliance with the commitments made to clients
• Preparation of submission of European dossiers in eCTD format (CP, MRP/DCP, renewals)
• Participate in working meetings with clients to solve the client’s issues
• Be actively involved in internal meetings with Pharmalex project teams. Acting Pro-actively in those meetings
• Participate in audits or diagnosis of dossiers
• Submit PSUR/PSUSA
• Control packaging and labelling texts
• Participate in archiving activities
• Comply with relevant quality procedures

The employee will actively participate to tasks corresponding with his/her abilities, including activities related to other Value Delivery Centres (VDCs) (Pharmacovigilance, DCS, Quality & Compliance), if asked by his/her management

Your Profile

• Successful completion of Pharmacist’s diploma or a scientific Master’s degree (in Regulatory Affairs), or in some cases a specialized bachelor’s degree
• 1 to 3 years of professional experience and project management experience
• Good Knowledge of English on top of Dutch or French.
• Good knowledge of European regulatory requirements for medicinal products
• Distinctly strong service orientation
• Content-related experience in several relevant areas of Regulatory Affairs
• Ability to manage one or several projects with limited guidance
• Autonomous approach to work, flexibility and dedication
• Diplomacy, ability to communicate and fit in an international and multicultural environment
• Strong sense of responsibility, organizational skills and intrinsic motivation
• Good knowledge of the MS-Office package
• professional communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise.

If you are interested to join our PharmaLex team taking over this challenging job opportunity in our future-oriented company, we look forward to receiving your application documents stating your earliest possible starting date and salary expectations online.

Agencies only by prior agreement for the specific job opportunity.