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General information

Sr Regulatory Affairs Officer

In the role of Senior Regulatory Affairs Officer at HAL Allergy in Leiden, you will have a very diverse job, containing all aspects of RA.

Working in a team of 4, you will be involved in the future implementation of RIM/ IDMP and mainly focus on Portfolio management; preparation & submission of applications and Product development; participation in multidisciplinary project teams, review of dossier sections and dossier building for clinical studies.

You will obtain, renew and adapt marketing authorizations in line with HAL Allergy’s marketing policy. Perform regulatory activities for in-vivo diagnostics and therapeutics for immunotherapy and request and support clinical trial (applications). In Project teams you will adequately bring the Regulatory issues and position forward and undertake action where required.
Tasks and Responsibilities
  • To compile full registration dossiers (Module 1 to 5) according to current demands in a way they can be submitted in the right format (electronically) to competent authorities.
  • To maintain and adapt existing registration dossiers and accompanying documents.
  • To submit request for dossier changes (variations) in countries where registrations exist or named patient allowances are mandatory.
  • To prepare for national and international registration procedures.
  • To respond to questions from competent authorities.
  • To assess patient information texts and labels and labelling of products.
  • In Project teams to bring the Regulatory issues and position adequately forward and where required action will be undertaken.
Requirements
  • Minimum of 5 years of experience in RA
  • Advanced level of Dutch and English, verbally and in writing
  • Adequate CMC experience and change management
  • Regulatory experience within clinical trials, phase 1-3 is preferred
  • Knowledge of biological or biotechnological products
  • Publishing knowledge and experience
  • Product development experience
Personal & Professional Skills
  • Being capable to function well within Project teams and be able to communicate adequately with Authorities.
  • To make a success of this very diverse role, it is important you can multitask, take ownership and work accurately.
  • You are a self-starter with a critical view of work and like the diversity this independent role brings.
  • Strong developed skills and interest in (publishing) software/E-tools
Offer
  • We offer you a highly dynamic job in an interesting environment.
  • You will be working from our headquarters in Leiden, where the products are produced on site.
  • HAL Allergy offers great benefits including a competitive salary, 13th month, 30 holidays, contribution to pension and health insurance.
Applications and more information
Interested? We look forward to receiving your application. To apply, please click the "Apply" button below to the right where you will be prompted to upload your CV first. 
Company Information

HAL Allergy is a modern leader in the field of biopharmaceuticals, located in the Leiden Bio Science Park in The Netherlands. Our core business is the development and manufacturing of therapies and diagnostics for allergic diseases.

 

With offices in major European countries, HAL Allergy is one of the European top players in the allergy immunotherapy business. Established in 1959 HAL Allergy has a long experience in developing, producing and selling allergy therapies with an immuno-modulatory effect, resulting in a reduction of symptoms and long-term disease suppression. These therapies are primarily used against common allergies such as hay fever, house dust mites allergy and allergic reactions towards wasp or bee stings.

 

We employ around 300 highly specialized people across various functions. The departments at our headquarters include Research & Development, Production, Quality Assurance, Clinical Development and Regulatory Affairs. Our staff works closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities.

 

We are a steadily growing and dynamic company with a culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.

 

In addition to the core business of HAL Allergy, our subsidiary HALIX was founded in 2012. HALIX is a contract development and manufacturing organization (CDMO) licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. As an end‑to‑end service provider, HALIX will serve its customers the full range from the first development steps to start of commercial production after successful registration of products.