Regulatory Affairs Director – M/F – open-ended contract

• Responsible for the firm registration submissions, such as, FDA submissions, EU notified body submissions and other regulatory documents in collaboration with quality department where needed.
• Advise in market access strategies and Pharmacoeconomics.
• Responsible for compliance with the ethical codes of conduct and of transparency guidelines related to the products and fields of activity integrating ethical codes from legislative bodies and vision on ethical conduct in collaboration with HR.
• Develop and implement regulatory strategies that ensure that products, procedures and policies meet and continue to meet applicable regulations in the countries where the firm commercializes its products.
• Serve as an internal resource to address and resolve any questions or issues of a regulatory nature.
• Responsible for reimbursement files in close collaboration with the Sales/Marketing department
• Vigilance: investigation of vigilance cases and reporting to the relevant authorities according to applicable legislation and company SOPs
• Can act as Person Responsible for Regulatory Compliance or as back-up

• You have an university degree in pharmacy or other healthcare-related university degree combined with relevant knowledge in biologics and semi-solid formulations through experience
• You have minimum 7 years of working experience in the field of regulatory affairs in a pharmaceutical environment
• You are fluent in English. Any other language is an asset.
• You have depth knowledge in applicable laws and standards such as EU MDR, c-GMP, CBER regulations, ICH, GMP, GDP
• Excellent written communication skills
• You are a motivated, hard-working and autonomous person
• You are open-minded and solution-oriented.

• Immediate start of work
• Pleasant working environment
• Young and dynamic team
• Multicultural environment

• Analysis of your application
• Pre-interview with RH Lab (by phone)
• Interview at RH Lab.
• 2 interviews with our client

Moovijob