Develop strategic analyses using regulatory insights to inform the business;
Prepare and submit regulatory dossiers (New Products, Renewals, Line Extensions and Variations);
Ensure robust responses to regulatory requests and queries;
Conduct regulatory assessments of new business opportunities in collaboration with the New Business team;
Maintain ongoing interactions with regional regulatory team members, medical affairs, market access and marketing;
Participate in product launch teams;
Monitor the company’s regulatory submissions and approvals;
Review promotional materials for the therapeutic area;
Own regulatory and competitive intelligence for the assigned therapeutic area;
Participate in industry association meetings and internal meetings with different departments, contributing expertise;
Interact with the Health Authority in meetings or via email;
Monitor the publication of new legislation, assess impacts, risks and opportunities, and develop a robust implementation plan;
Ensure compliance with regulations and the regulator’s interpretations;

Bachelor’s degree in Pharmacy, Biology, Biochemistry, Microbiology, Chemistry or related fields;
Solid professional experience in regulatory affairs, preferably with product registration and pipeline experience;
Thorough knowledge and experience with pharmaceutical industry regulations;
Proficiency in Microsoft Office;
Strong problem-solving skills;
Advanced English (Spanish desirable);
Availability to work in a hybrid model: 3 days per week in the office.

Senior Regulatory Affairs Analyst

Key skills