regulatory affairs support - 2361

requirements :

• university degree (or similar such as a1 in belgium), preferably in a science related to medicine,
• at least four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.
• good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in english.
• can work across boundaries, demonstrates the ability to act as intermediary across boundaries.
• demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
• demonstrates ability to coordinate tasks with others for timely completion and to avoid setbacks.
• demonstrates the ability to check regulatory documents to determine accuracy and find potential errors.

main responsibilities :

support ra activities in the eu, uk, switzerland and the non-eu balkan countries for products approved through the centralized and decentralized/mrp procedures – in collaboration with the regulatory liaison.

• provides administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to eu requirements.
• plans and coordinates new submissions, variations, chmp referrals, fum. to ensure timely submission.
• drafts of module 1 components and organizing the gathering of the module 1 components.
• collaborates closely with regulatory operations to establish submission timelines and content of module 1.
• collaborates closely with country ra registration managers in order to ensure timely submission.
• for the centralized procedure, supervises and coordinates the translation process to ensure timely submission to ema.
• provides other administrative support related to marketing authorization applications to the executive director, distinguished scientist, senior principal scientist, associate principal scientist or senior scientist as needed.
• ensures updates to regulatory databases.

consultancy

we offer an attractive salary with extra-legal advantages:

• group insurance
• hospitalisation insurance
• meal vouchers of 7 euros gross per working day
• reimbursement km or company car
• monthly allowance (80 euros net per month)
• a 13th month
• training
• etc.