Regulatory Professional

We are looking for a Regulatory Professional
World leader in allergy
ALK's aspiration is to become the world leader in allergy by helping as many people as possible to a better life by providing options of prevention, diagnosis, and treatment of allergy.

Experience and qualifications required in the job

• ≥3 years as Regulatory Affairs Professional in a pharmaceutical company, preferably multinational.
• Experience in international projects will be an asset.

• Bachelor of Science / Master of Science in the Health Science field (e.g. Pharmacy, Biology, etc.).
• Master's Degree in the Pharmaceutical Industry is strongly recommended.
• Specific regulatory affairs courses strongly recommended.

Responsibilities

• Handling regulatory CMC documentation of the products manufactured at site Madrid, for world-wide submissions (MAA, Variations, Renewals).
• Maintenance activities (CMC variations) for the products manufactured at site Madrid and registered world-wide.
• Local regulatory activities for the products registered in Spain.
• Handling product information (SmPCs, leaflets, labels).
• Regulatory surveillance & regulatory support to other functional areas.
• Member of cross-functional / cross-site projects.

Important tasks to be handled in the job:

• Coordination, preparation & submission of CMC documentation (CTD Modules 2.3 & 3) for Marketing Authorisation Applications / Variations / Renewals of products manufactured at site Madrid, in compliance with local or regional requirements, including input to the regulatory strategies & responses to questions from regulatory authorities during assessment.
• Coordination, preparation & submission of CMC documentation for post-approval regulatory commitments.
• Handling the national phase of variations/MAA submitted by European procedures (MRP/DCP) for products manufactured at other ALK sites - including fee payment, translation to local language of product information (SmPC, PL, Labelling), change requests for printed packaging materials – and follow-up with AEMPS until approval.
• Preparation & submission of documentation on products manufactured at site Madrid, to obtain special licences/import licenses in other countries.
• Reviewing change control requests, including assessment of regulatory impact, defining variation classification/documentation needed and submitting the corresp0nding variation applications.
• Writing/adapting to local requirements SmPCs, PL, labels & abridged SmPCs for promotional materials.
• Applying for Certificates of Pharmaceutical Products (CPP) / Free Sale Certificates / other & handling or coordinating the subsequent legalization process.
• Handling local activities for the products registered in Spain, e.g. product launch notifications & applications for yearly maintenance of the products via AEMPS portal.
• Providing regulatory input to the Annual Product Quality Review (APQR).
• Electronic archiving of all documentation concerning MAA/variations submitted & authorised for the products under his/her responsibility in the VEEVA RIM system, ensuring they are kept up to date.
• Keeping abreast of regulatory procedures & changes to national/international legislation and providing regulatory support to other functional areas / sites.
• Participating in strategic international projects.

Competences

• Knowledge of the European Regulatory Environment (procedures, legislation, guidelines, CTD, etc)
• Fluent in English – experience in writing technical / scientific documentation in English.

Personal Skills

• Organised, methodical and pays great attention to detail.
• Collaborative - works well as a team, but also autonomously and able to take own decisions.
• Agile – takes quick action.
• Problem-solving attitude.
• Goal-oriented.
• Not afraid of challenges.
• Works well under pressure (e.g. tight deadlines).
• Good communication skills (especially written).
• Quick to learn.
• Takes responsibility for own work.
• Committed.
• Adapts quickly to change.

Important information
The position is based at ALK’s site in Madrid, located in the business area of Ciudad Lineal. We have a quick access to the Hermanos García Noblejas and Ascao metro stations and a wide bus connection network. The production site is located at Calle Miguel Fleta 19 while the Business Support area is next door, Santa Leonor 65, in a building called Avalon Business Park. Nevertheless, we have a remote working policy that will allow you to work from some days (you will receive ad-hoc information in the recruitment process).

ALK, among other benefits, has a canteen where employees can have breakfast and lunch every day.

If this sounds like a company mission, job and a department you would like to be part of, we hope to receive your CV and application, but please do not send your CV via e-mail due to GDPR rules.