Regulatory Affairs Biosimilar Specialist LATAM
Experience: 5+ years in Regulatory Affairs within innovative biopharmaceuticals and/or biosimilars
Se pueden requerir diversas habilidades interpersonales y experiencia para el siguiente puesto. Por favor, asegúrese de consultar la descripción a continuación con atención.
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
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.
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.
Providing regulatory leadership and expert guidance to core project teams and sub-teams.
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.
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.
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.
More than 5 years of experience in Regulatory Affairs within innovative biopharmaceuticals and/or biosimilars.
Fluent English and Spanish.
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.
Permanent contract
Be part of high-impact strategic projects
Work closely with global and cross-functional teams
Opportunities for learning and professional development
Initial contact with the Talent Acquisition team
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.