Título del puesto:  Regulatory Affairs Specialist - Biotech

Regulatory Affairs Specialist - Biotech

• In a nutshell 📌
• Position: Regulatory Affairs Specialist – Biotech
• Location: Madrid
• Experience: 5+ years in Regulatory Affairs within biotechnology or biopharmaceuticals, including more than 2 years of experience in biosimilars

Want to know more? 👇

At Exeltis, we continue to grow and are looking for a Regulatory Affairs Specialist - Biotech to contribute to the regulatory strategy and registration of innovative medicines and biosimilars in international markets.

If you are passionate about Regulatory Affairs, have solid experience in biosimilars and enjoy working with cross-functional teams, this could be your next opportunity

What are we looking for? 🔎

We are looking for a proactive, collaborative and solution-oriented professional with a strategic mindset, strong communication skills and the ability to manage regulatory challenges in a dynamic international environment.

The challenge! 🚀

In this role, you will contribute to the definition and implementation of regulatory strategies throughout the product lifecycle. Your main responsibilities will include:

• Define and execute regulatory strategies for innovative biopharmaceuticals and biosimilars, in coordination with Management, R&D, Business Development, Commercial teams.
• Monitor the regulatory landscape, assess the impact of changes and adapt strategies to evolving requirements and Health Authority feedback.
• Identify regulatory risks and develop mitigation plans in collaboration with cross-functional teams.
• Review the translation of regulatory dossiers from English into Spanish.
• Follow up with licensors to ensure the timely delivery and availability of regulatory documentation.
• Follow up with local teams on GMP requests and ensure the timely receipt of the required documentation.
• Coordinate the preparation, review and submission of regulatory documentation, including briefing packages, IBs, INDs, CTAs, MAAs and responses to deficiency letters.
• Lead or support interactions with Health Authorities, including Scientific Advice procedures, presentations and responses to regulatory questions.
• Interpret and communicate regulatory requirements related to product development, manufacturing and registration.
• Collaborate with R&D, QA, QC and Production teams on regulatory strategy and CMC documentation.
• Participate in project teams, development review boards and scientific committee meetings, providing regulatory guidance.
• Support the review of license agreements and quality technical agreements for target markets.
• Manage external consultants and vendors involved in regulatory activities.
• Coordinate submission timelines with Regulatory Affairs teams in line with business priorities and commercial needs.
• Support product launch activities and post-approval regulatory planning.
• Maintain regulatory files and databases, ensuring data integrity and timelines and project progress are kept up to date
• Prepare reports on project status and progress for senior management.
• Manage and track post-approval changes.
• Promote the use of digital tools and computerized systems within the Regulatory Affairs function.

What do you need? 🤓

Essential requirements

• Degree in Health Sciences, preferably Pharmacy. Degrees in Chemistry, Biology, Biochemistry, Veterinary Sciences or a related field will also be considered.
• 5+ years of experience in Regulatory Affairs within biotechnology or biopharmaceuticals.
• More than 2 years of hands-on Regulatory Affairs experience with biosimilars.
• Strong knowledge of pharmaceutical legislation and regulations, including GMP and ICH guidelines.
• Fluent Spanish and English.
• Proficiency in Microsoft Office tools and regulatory software.
• Strong communication, influencing, organizational and problem-solving skills.
• Ability to work effectively with international and cross-functional teams.
• Willingness to travel.

Nice to have

• Experience with biosimilar registrations or regulatory submissions to ANVISA in Brazil.
• Knowledge of biosimilar regulatory requirements and submission procedures in Latin American countries.
• Additional languages.