Regulatory Operations Legacy Products Maintenance 1

Mission

Within the Regulatory Operations Department, we are looking for a Junior Regulatory Affairs Specialist for Legacy Products Maintenance.

This position will be supporting regulatory activities leading to successful life-cycle management for Almirall Global products approved worldwide in liaison with CMC and roll out product responsible. This individual will participate in cross-functional teams for product launches and product changes in compliance with local regulations and in close collaboration with Almirall Market companies, Partners and local consultants.
The Junior Regulatory Affairs Specialist should have the ability to collaborate on the Regulatory approach for non-CMC changes. 
 

Functions & responsibilities

•    Execute regulatory strategies and submissions plan to international for post-approval changes and responses to Health Authority queries through liaison with Local RA managers and CMC and roll-out responsible for applicable markets
•    Obtain the necessary documents and prepare and/or review of variation packages for labelling, administrative, clinical and non-clinical changes for assigned product(s) lifecycle maintenance for markets in the international region ensuring they are delivered to partners, market companies and health authorities within the established deadlines
•    Monitor regulatory procedures up to final resolution, reporting on the regulatory databases all relevant information and associated documents. Also, inform the organization as per internal procedures to ensure implementation of regulatory changes.
•    Monitor the registration status of products under responsibility and keep annual schedule of Renewals and Variations updated with all regulatory procedures to be performed.
•    Supervise activities carried out for regulatory purposes through consultants, CROs, local agents and partners
•    Collaborate in drawing up and maintaining policies and procedures that govern regulatory operations with market companies and partners
•    Provide regulatory expertise in coss-functional projects aligned with business strategy definition 
•    Request the implementation of regulatory changes to packaging materials according to the established deadlines
•    Provide support to Regulatory Strategy and Roll-out to resolve any critical post-approval issues
 

Education

•    Bachelor’s Degree in Life Sciences. Advanced degree preferred but not required.

Experience

•    Minimum 2 years work experience in regulatory affairs in countries part of the International Region (EU, Turkey, Russia, CIS, MEA, LATAM, APAC regions)
•    Knowledge of post-approval regulatory procedures in the international markets. 
•    Fluent English.  
•    Ability to build team relationships and collaborate in a global team environment with key stakeholders across the organization
•    Ability to effectively collaborate with various business functions as well as cooperate with some scientific disciplines
 

Values

•    Care; we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
•    Courage; we challenge the status quo, we take full ownership and we learn from our success & failures
•    Innovation; we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets. 
•    Simplicity; we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.