Regulatory Affairs Biosimilar Specialist LATAM

Exeltis; Madrid; Presencial; EUR 80.000 - 110.000; Jornada completa

Descripción de la vacante

Exeltis is seeking a Regulatory Affairs Biosimilar Specialist to lead regulatory strategies for biosimilars across international markets, based in Madrid. The role requires a strategic mindset, strong influencing skills and extensive experience in regulatory submissions.

You will collaborate with R&D, BD and Commercial teams, manage submissions (IBs/INDs/CTAs/MAAs), guide Health Authority interactions and drive risk mitigation and digitalization within the function.

Formación

• Degree in Health Sciences, preferably Pharmacy.
• More than 5 years of experience in Regulatory Affairs within innovative biopharmaceuticals and/or biosimilars.
• Fluent English and Spanish.
• Knowledge of biosimilar registrations with ANVISA (Brazil).

Responsabilidades

• Define regulatory strategy for each product with Regulatory Affairs Director and cross-functional teams.
• Monitor regulatory landscape changes and identify impact on the company.
• Prepare and manage regulatory submissions (IBs, INDs, CTAs, MAAs).
• Lead Health Authority interactions during Scientific Advice procedures.
• Support Business Development and Commercial Operations with regulatory input on licenses and agreements.
• Drive risk mitigation and digitalization within the Regulatory function.

Conocimientos

Regulatory strategy

Cross-functional collaboration

Regulatory leadership

Influencing skills

Regulatory intelligence

Educación

Degree in Health Sciences/Pharmacy

Chemistry/Biology related degree

Herramientas

Word

Excel

PowerPoint

MS Project

Descripción del empleo

Position: Regulatory Affairs Biosimilar Specialist LATAM

Location: Madrid

Experience: 5+ years in Regulatory Affairs within innovative biopharmaceuticals and/or biosimilars

Want to know more?

At Exeltis, we continue to grow and we are looking for a Regulatory Affairs Biosimilar Specialist ready to take the next step in their career in an international, innovative and high-impact environment.

If you are passionate about Regulatory Affairs, have strong experience in biosimilars, and enjoy defining strategies, anticipating risks and working cross-functionally with different teams, this could be your next great opportunity

You will join a strategic role with high visibility across the organization, contributing to the development and registration of complex products in international markets.

What are we looking for?

We are looking for an experienced Regulatory Affairs professional with a strategic mindset, strong influencing skills and solid expertise in biosimilars and innovative biopharmaceuticals.

We want to add a proactive, solution-oriented and collaborative person who can provide regulatory insight, business alignment and strong execution in a global and evolving environment.

The challenge!

In this role, you will play a key part in defining and executing regulatory strategies for biosimilars and complex drugs. Your main responsibilities will include:

• Monitoring changes in the regulatory landscape and identifying their impact on the company.


• Defining the regulatory strategy for each product in coordination with the Regulatory Affairs Director, Business Development and Commercial teams.


• Building regulatory plans aligned with business and functional priorities.


• Identifying regulatory risks, defining mitigation actions and driving implementation with cross-functional teams.


• Adapting regulatory strategies in line with evolving regulations and Health Authority feedback.


• Providing regulatory leadership and expert guidance to core project teams and sub-teams.


• Interpreting legislation and regulatory requirements related to product registration, manufacturing, development and procedures.


• Ensuring regulatory requirements are appropriately communicated through company policies and procedures.


• Supporting Business Development and Commercial Operations in the review of License Agreements and Quality Technical Agreements for target geographies.


• Providing regulatory guidance in product development review boards, project teams and scientific committee meetings.


• Defining and implementing regional regulatory strategies for innovative drugs, complex generics and biosimilars in line with business objectives.


• Advising R&D and Business Development teams on regulatory requirements for registration dossiers and Scientific Advice submissions.


• Leading interactions with Health Authorities during Scientific Advice procedures.


• Preparing, reviewing and approving regulatory submission documents, including briefing packages, IBs, INDs, CTAs, MAAs and responses to deficiency letters.


• Leading Health Authority engagement and response strategies for deficiency letters.


• Managing external consultants and third-party vendors involved in regulatory activities.


• Supporting product launch activities.


• Ensuring regulatory risks identified during product development and/or post-approval are mitigated through appropriate action plans and integrated into program planning.


• Managing regulatory information flows with other departments across the organization that may impact the business.


• Identifying and using tools to achieve individual, team and company objectives in a high-quality, timely and cost-effective way.


• Driving digitalization and the use of computerized systems within the function.


• Monitoring data integrity and maintenance of regulatory files and databases.


• Organizing the submission schedule for Regulatory Affairs Officers according to the Business Plan and commercial needs.


• Conducting presentations and negotiations with agency reviewers when needed.


• Participating in product plan development and implementation, regulatory strategy, risk management and CMC documentation.

What do you need?

• Degree in Health Sciences, preferably Pharmacy.


• Degrees in Chemistry, Biology, Biochemistry, Veterinary Sciences or similar will also be considered.


• More than 5 years of experience in Regulatory Affairs within innovative biopharmaceuticals and/or biosimilars.


• Experience and knowledge in biosimilar registrations with ANVISA (Brazil).


• Knowledge of biosimilar requirements for new submissions in Latam countries.


• Fluent English and Spanish.


• Additional languages will be considered a plus.


• Strong knowledge of general pharmaceutical legislation and regulations, including GMP and ICH guidelines.


• Proficiency with standard software tools such as Word, Excel, PowerPoint, Project and specific regulatory tools.


• Willingness to travel.


• Join a growing international pharmaceutical company


• Be part of high-impact strategic projects


• Work closely with global and cross-functional teams


• Opportunities for learning and professional development


• Dynamic, innovative and excellence-driven environment

What will the selection process look like?

We want your candidate experience to be clear, smooth and transparent:

• Initial contact with the Talent Acquisition team


• HR interview


• Interview(s) with the Hiring Manager and key stakeholders


• Ongoing communication and feedback throughout the process

EQUAL OPPORTUNITIES COMMITMENT

At Exeltis, we are committed to equal opportunities and to building a diverse and inclusive workplace. All applications will be assessed without discrimination based on gender, gender identity or expression, sexual orientation, age, ethnicity, nationality, religion, disability or any other personal or social condition. We promote selection processes based on merit, capability and respect.