As a regulatory affairs you'll be the crucial link between your company, the client, its products and regulatory authorities. You'll combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a range of companies, meet the required legislation.

Compiles and manages the Registration dossier or the Variation packages and coordinates with the Marketing Authorization Holders for submission and follow up until product approval and launch, or change implementation. Organizes regulatory information, logs and tracking.

As a regulatory affairs officer, you'll need to (but not restricted to)

- ensure that a company's products comply with the regulations of the regions where they want to distribute them
- keep up to date with national and international legislation, guidelines and customer practices
- collect, collate and evaluate scientific data from a range of sources
- develop and write clear arguments and explanations for new product licences and licence renewals
- prepare submissions of licence variations and renewals to strict deadlines
- monitor and set timelines for licence variations and renewal approvals
- work with specialist computer software and resources
- write clear, accessible product labels and patient information leaflets
- plan and develop product trials and interpret trial data
- advise scientists and manufacturers on regulatory requirements
- provide strategic advice to senior management throughout the development of a new product
- project manage teams of colleagues involved with the development of new products
- undertake and manage regulatory inspections




- review company practices and provide advice on changes to systems
- liaise with, and make presentations to, regulatory authorities
- negotiate with regulatory authorities for marketing authorisation
- take part in the development of marketing concepts and approve packaging and advertising before a product's release.
- Serves as regulatory liaison throughout product lifecycle.
- Serves as regulatory representative to marketing, R&D; teams and regulatory agencies.
- Art 57 reporting

Innovation, customer orientation, good oral and written communication skills, teamwork, adaptability/flexibility, productivity, Self-development, sense of urgency, initiative
- Education: Degree in Pharmacy, Chemistry or Biology.
- Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
- Experience (years/area): 2 years of experience in the same functions.
- Specific Knowledge: Very good knowledge of general pharmaceutical legislation and regulations, including GMP, and expertise in ICH guidelines and registration dossie,r CTD format content. Proficiency with standard software tools (Word, Excel, PowerPoint, Project, etc.).
- Travels: Occasionally. Availability to work in Barcelona, Madrid and León headquarters.
- Personal skills: Ability to work in a team and autonomously, multitasking and adaptable to schedule changes, ability to work under pressure (short deadlines), creative and good oral and written presentation skills.
- KPI related to the job.
- Competitive salary based on your professional experience and expectations.
- Great work environment.
- Variable compensation program for permanent employees.
- Customized flexible compensation.
- Telecommuting or hybrid position possibility.

📌 Regulatory Affairs Junior (Medical device) (Alcobendas)
🏢 Qualipharma
📍 Alcobendas