Company: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries.
At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Therefore, our goal is to make a difference by significantly improving the health and quality of life of patients and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases. We attract and develop bold, agile, and entrepreneurial people who take full responsibility for their decisions;
We offer employees a wealth of rewarding challenges and growth opportunities, and the chance to contribute within a constantly moving organization, an organization that truly changes the game. At Ipsen, we are looking for a Regulatory Affairs Officer Iberia , based in Barcelona , who, under the direction of the Regulatory Lead Iberia, will compile, elaborate and revise all documentation to submit the Marketing Authorization Applications (MAAs), Marketing Authorization (MA) variations and renewals to the Health Authorities, in accordance with the Ipsen procedures and local legislation. Management of packaging materials for medicines.
To review the promotional activities of the products in charge of generated by the marketing & medical department in accordance with the Local Regulation, Code of Conduct and Ipsen policies.
Regulatory Affairs To keep and update the archive, databases and registration status of the products, as well as of the documents submitted, projects and fees.
Management of packaging materials for medicines. Regular update of knowledge of procedures and legislation / guidelines applicable to Regulatory Affairs and to Promotion of Medicines.
Business & Ethics Ensure his/hers responsabilities comply with the spirit and letter of EFPIA codes, local guidelines or regulatory rules and IPSEN SOPs. Proactively advocate for best practices across functions to maintain high level of compliance To maintain membership of societies and professional organisations of interest to the company, according to local legislation and the Group’s guidance; Regulatory Affairs (management of lifecycle of pharmaceutical products: national, mutual recognition, decentralized and centralized procedures, revision of promotional/non-promotional materials and activities) Regulatory Affairs (management of lifecycle of pharmaceutical products: national, mutual recognition, decentralized and centralized procedures, revision of promotional/non-promotional materials and activities) Degree in Scientific discipline (Pharmacy, Chemistry, or Biological Sciences) with accredited training on Regulatory Master in Pharmaceutical Industry and Postgraduation in Quality, Pharmacovigilance and Regulatory Affairs of the Pharma Industry Expert/fluent communicator in Spanish and English. Expert/fluent communicator in Portuguese and English.
Knowledge of Portuguese is a valuable asset Able to be focused and performance-driven with clear KPIs Joining Ipsen means becoming part of a general biopharmaceutical group focused on innovation and specialized care in three key therapeutic areas: oncology, neurosciences, and rare diseases. Ipsen's Human Resources policy pays special attention to ensuring that all employees have good working conditions, including a adaptable working hours model, training and development programs, as well as social benefits and competitive remuneration based on three main principles: internal equality, external competitiveness, and recognition of work. TYPE OF CONTRACT Permanent – Full-time
📌 Regulatory Affairs Officer Iberia (Laza)
🏢 Ipsen
📍 Laza