Senior Regulatory Affairs Officer (Biologics) en Madrid , España

Responsible for performing, reviewing and approving local regulatory affairs activities, with especial focus in the Spain registration process for allergen medicines (Orden Ministerial SND/778/2023).

Client Details

International Pharmaceutical Company

Description

• Ensure regulatory systems, such as Regulatory Database/trackers are implemented and kept up to date.


• Work with internal & external customers to provide data and accurate regulatory input.


• Prepare & review labelling/Packaging texts and information brochures and communication activities.


• Run regulatory local projects meeting timelines and costs


• Understand relevant legislative and regulatory guidance applicable to activities


• Prepare risk benefit analysis


• Active involvement in concepts of regulatory strategy


• Attend industry and RA meetings


• Communicating with local regulatory agencies and document communication


• Provide local RA support to local Sales, Customer Services, QA, LSO, Medical and Marketing depts.


• Prepare and update local SOPs


• To comply with all Good Regulatory Practices, refer to formalized, mandatory policies that define common and transparent rules for regulatory agencies.


• To carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and Others.


• To control and maintain your personal training folder.


• To comply with all Company policies and procedures.


• To follow a code of conduct conducive to a professional environment

Profile

• Life sciences degree related to the activity


• Minimum of 5 years in the regulatory pharmaceutical field (preferred experience with biological products)


• Demonstrated ability to write good quality documents


• Highly PC literate


• Project management abilities


• Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets


• Fluency in English language

Job Offer

• Flexible hybrid model (up to 4 days home office), during trial period non applicable.


• Flexible shift


• Madrid or Barcelona based


• Social benefits