Regulatory Affairs Officer Iberia

The patient is at the center of everything we do, and we also care about our employees because they are the ambassadors and the ones who truly make a difference. We attract and develop bold, agile, and entrepreneurial people who take full responsibility for their decisions; leaders drawn to the purpose of making a direct impact through their work on people's lives.

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.

Who are we looking for?

Requirements:

Knowledge & Experience (essential):

• Experience in a similar position with a proven experience in

• Regulatory Affairs (management of lifecycle of pharmaceutical products: national, mutual recognition, decentralized and centralized procedures, revision of promotional/non-promotional materials and activities)

• Approximately 1-2 years in similar position

Knowledge & Experience (preferred):

• Experience in a similar position with a proven experience in

• Regulatory Affairs (management of lifecycle of pharmaceutical products: national, mutual recognition, decentralized and centralized procedures, revision of promotional/non-promotional materials and activities)

• Approximately 2-3 years in similar position

Education / Certifications (essential):

•  Degree in Scientific discipline (Pharmacy, Chemistry, or Biological Sciences) with accredited training on Regulatory

Education / Certifications (preferred):

•  Master in Pharmaceutical Industry and Postgraduation in Quality, Pharmacovigilance and Regulatory Affairs of the Pharma Industry

Language(s) (essential):

• Expert/fluent communicator in Spanish and English.

Language(s) (preferred):

• Expert/fluent communicator in Portuguese and English.
• Knowledge of Portuguese is a valuable asset

Competencies:

• Drive Purpose:

• Puts values and ethics at the forefront of everything;
• Anchors Ipsen's purpose, mission and commitments to patients and society.

• Manage Complexity:

• Identifies contradictory information/demands/inputs to effectively solve problems;
• Develops and evaluates alternative scenario and solutions;
• Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact.

• Mindfulness Risk-taking:

• Methodically assesses, transparently shares, and makes risk-informed decisions;
• Empowers to take ownership and accountability.

• Excellence in execution:

• Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society;
• Able to be focused and performance-driven with clear KPIs
• Plans and aligns effectively (steps, resources, timelines etc.)

Displays a commitment to best practice sharing and setting

What do we offer?

Joining Ipsen means becoming part of a global 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 flexible 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