We are actively hiring and looking for enthusiastic and experienced Regulatory Affairs Professionals.
- Do you have a Scientific degree, in life sciences or in pharmacy?
- Do you have a first experience in Regulatory Affairs?
- Are you fluent in english?
We have several RA opportunities on a regular basis: RA officers, RA manager (CMC), RA submission specialist, RA compliance associate, Technical RA system analyst or combined RA/QA positions.
Maybe you are the new colleague we are looking for!
Regulatory Affairs is developed from the desire of governments to protect public health, by controlling the safety and efficacy of pharmaceutical products. It is important for pharmaceutical companies to supply products that are safe and make a worthwhile contribution to public health and welfare. As a Regulatory Affairs (RA) Professional you play a crucial role in the lifecycle of a medicine, you guide the drug through all phases of development.
The RA department is closely involved in concept development, realization, production, packaging and marketing of the medicine. There is a close collaboration with other departments within the company as well as a continuous cooperation with the government.
- You keep track of ever-changing regulation in all regions where the product is distributed.
- You advise on legal and scientific restraints and requirements.
- You collect and evaluate scientific data, generated by your R&D colleagues and relevant stakeholders.
- You are responsible for the presentation of registration documents to regulatory agencies.
- You oversee all the deadlines and keep track that the submission milestones are reached.
- You maintain the system processes, identify process optimization opportunities and assist in the resolution of technical issues for the publishing dossiers.
- You interact with local authorities and carry out all negotiations necessary to obtain and maintain marketing authorization for the product.
- You are responsible for drafting and maintaining product labeling, instruction leaflets and packaging.
- RA compliance: risk analysis, SOP drafting, CAPA follow-up, attendence to Regulatory Audits, ...
- Submission specialist: You are responsible for complete management of regulatory documents (e.g. submissions, variations, renewals, PSURs,..) EMEA level, cordinatate registration activities, develop and implement submission strategy, ....
- CMC: life-cycle writing activities, writing responses to Questions raised by Reg. Authorities, update and internal tracking of systems for CMC activities,....
- Technical RA system analyst: ensure that the RA processes are accurate and user documentation systems are maintaned according to the latest regulatory changes
- You have a Scientific degree, in life sciences or pharmacy
- You have a first experience in Regulatory Affairs
- You have strong communication and organizational skills
- You have strong analytical mindset
- You are a team player and you have strong interpersonal skills
- You are able to work independently within your area of responsibilities
- Knowledge of Sharepoint is a plus
- You have an eye for detail and affinity with administration, meticulous and quality-minded
- You have advanced computer skills
- You possess a good knowledge of languages: fluent in English and Dutch
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