Regulatory Affairs Officer Iberia

Your main responsibilities will include:

Regulatory Affairs

• To compile, revise and translate the dossiers and documents received from GRA for new MAA, variations, renewals and others related to the drug’s life cycle, submit them to the Health Authorities and follow-up until finalization.
• 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.
• To revise and approve product’s promotional and non-promotional material according to the guidelines and ethics code in force and to report it to Infarmed, when applicable.
• 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.
• This includes, but is not restricted to, maintaining high professional standards of conduct, in line with Ipsen Company Standard Operating Procedures, with a duty of care to the reputation of the company.

Collaboration with other Departments

• Proactively advocate for best practices across functions to maintain high level of compliance
• Proactively identify areas for process improvement and mediate cooperation cross-functionally
• Contribute towards stakeholder value by providing leadership and operational input towards affiliate strategic and tactical activities

Communication

• To respect and apply the company rules (especially the confidentiality ones) and strategy in communication with media, authorities and health professionals;
• To maintain membership of societies and professional organisations of interest to the company, according to local legislation and the Group’s guidance;
• To act with all relevant authorities/entities, with a great sense of public relations, having in perspective an increased efficiency and recognition of Ipsen;
• To maintain and develop positive and ethical interactions with relevant authorities;
• To respect and apply the IPSEN ethical code

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

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.