Regulatory Affairs Senior Officer

ASPHALION; Madrid; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A growing pharmaceutical company seeks a Regulatory Affairs Senior Officer in Madrid. The role involves managing submissions, strategic advice, and communication with health authorities. With a commitment to employee development, Asphalion offers a flexible, inclusive work environment and various benefits including remote work options.

Servicios

Flexible working hours

Home office options

Training and English lessons

Employee well-being programs

Formación

• At least 4 years of experience in Regulatory Affairs within Pharma.
• Proficiency in MS Office and advanced IT skills.
• Good communication skills and attention to detail.

Responsabilidades

• Submitting MAA, variations, and renewals nationally and globally.
• Managing Pricing and Reimbursement processes.
• Leading regulatory projects to ensure timely execution.

Conocimientos

Communication skills

Attention to detail

Proactive attitude

Educación

Academic Degree in Life Sciences

Herramientas

MS Office

Descripción del empleo

Asphalion is growing, and we are looking for a Regulatory Affairs Senior Officer with experience in the pharmaceutical industry. We seek someone who loves new challenges, enjoys working in an international environment, and wants to grow with us!

Main responsibilities:

1. Submitting MAA, variations, renewals, and procedures both nationally and worldwide, including EU, US, CH, and RoW.
2. Managing Pricing and Reimbursement processes.
3. Communicating with Health Authorities.
4. Adapting documentation to the Transparency Policy 0070.
5. Providing Strategic Regulatory Advice.
6. Reviewing promotional materials, packaging, and labelling.
7. Leading and managing regulatory projects to ensure timely and successful execution.

Requirements:

• At least 4 years of experience in Regulatory Affairs within Pharma departments.
• Academic Degree in Life Sciences.
• Proficiency in MS Office and advanced IT skills.
• Proactive attitude, good communication skills, accuracy, and attention to detail.

Why work at Asphalion? We offer a permanent contract, flexible working hours (including Fridays until 15:30), home office, and hybrid or remote work options. You can be located anywhere in Spain! Enjoy a variety of projects, new challenges, and opportunities for personal development, including training and English lessons. Our inclusive, high-performance environment fosters growth and skill development. We pride ourselves on a company culture centered around Passion, Flexibility, Commitment, Quality, and Camaraderie. Join a dynamic team with colleagues from over 15 nationalities. We prioritize employee well-being through comprehensive physical, psychological, and emotional support programs, along with internal activities and RSC initiatives. We are an Equal Opportunity Employer.