Sr. Regulatory Affairs Officer at HAL Allergy
To obtain, renew and adapt marketing authorizations (product registrations or allowances for named patient products) in line with Company’s marketing policy, in a way that marketing remains allowed or will become.
To perform regulatory activities for in-vivo diagnostics and therapeutics for immunotherapy.
To request and support clinical trial (applications). In Project teams the Regulatory issues and position is brought forward adequately and where required action will be undertaken.
For part of the employees: a leading role will be performed in respect of creation of core labelling. A leading role must be performed in relation to maintenance of eCTD software and the XEVMPD database.
HAL Allergy is a modern company with high quality pharmaceutical GMP manufacturing and research facilities located in the Leiden Bio Science Park. With offices in seven European countries, we are one of the top European players in the field of allergy diagnostic and treatment. Since 1959 we have gained experience in developing, producing and selling allergy therapies for the treatment and prevention of allergic diseases. These immunotherapies are used primarily against common allergies such as hay fever, house dust mite allergy and allergic reactions towards wasp or bee stings. Beside the development and production of allergy vaccines, HAL Allergy started a new business in 2012. This new Contract Manufacturing Organization (CMO), named HALIX, is engaged in the production of biotechnological products for preclinical and clinical studies. HAL Allergy Group is a mid sized company with headquarters in Leiden. We employ around 300 highly specialized people acorss various functions. The departments at our headquarters include development, production, quality assurance and control, clinical and registration. Our staff work closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities
As Officer of the department Regulatory Affairs you are responsible for the compilation of (parts of) dossiers for national and European ((MRP) procedures, to maintain already existing registrations, to compose and execute changes, correspondence with registration authorities, coordination of and management of product information texts. Depending on the production line, the coordination of obtaining agreement on clinical trials can also be part of the job. Furthermore we want to utilize your skill set to bring the department to the next level.
- Academic or Bachelor degree.
- Education/training relevant for Regulation Affairs is an absolute asset.
- At least three years of proven and relevant working experience within Regulatory Affairs.
- Specialist on legislation with respect to registration.
- Preferably experience with international registration procedures.
- Proven experience with creation of and maintaining of electronic dossiers (eCTD).
- Proven experience in maintaining a registration information system (RIM).
- Proven experience in the writing of technical dossier texts.
- Proven experience in the writing of SPC/PIL core texts.
- Experience with functioning in project teams.
Personal and professional skills:
- Excellent command of both Dutch and English., both in speaking, reading and writing.
- Critical thinking.
- Negotiation skills and persuasive skills.
- Stress resistant.
- No 9-5 mentality.
No unsolicited assistance from search firms is accepted for this employment opportunity