If you are a professional with experience in the pharmaceutical regulatory field and are looking for an opportunity to contribute to the compliance and quality of manufacturing processes in a leading company, this is a great opportunity for you to join our team as Manufacturing Regulatory Specialist.
The position:
Alfasigma is looking for a Manufacturing Regulatory Specialist who supports the compliance of manufacturing processes and products with national and international regulations. This position involves close collaboration with production, quality, and development teams to ensure that all activities adhere to current regulations and industry guidelines.
Main responsibilities:
* Carry out regulatory impact assessments resulting from changes and/or corrective actions required for the resolution of non-conformities linked to quality events (deviations, complaints);
* Coordinate the drafting and ensures the verification and collection of the regulatory documentation to support the quality variations and/or Deficiency Letters connected to them (both intended for changes of existing products and for the submission of new products) and the assembly and revision of the documents to support requests for plant changes, for which it also carries out the filing process;
* Guarantee continuous monitoring of regulatory compliance between operational practice and the reference registration documentation, identifies any gaps and supports the definition of the recovery plan;
* Ensure the drafting, conservation and periodic updating of all regulatory documentation, in order to guarantee full compliance with the relevant provisions of the relevant regulations;
* Contribute to the updating and continuous improvement of the company quality management system in compliance with the good manufacturing practices in force and the Marketing Authorizations;
* Provide support during inspections of Regulatory Authorities and customers: to contribute to the definition and implementation of the subsequent follow up for the resolution of any non-conformities found within the times established by the regulations and/or agreed with the counterparty;
* Support company management in the evaluation and acquisition of new products and technologies by defining the regulatory impact at plant level and supporting quality level evaluation;
* Support the company functions responsible for conducting and certifying investigations into quality events (deviations, complaints, OOS, OOT), helping to identify the necessary corrective and preventive actions (CAPA) and evaluating their impact on the qualitative and regulatory aspects connected to the product under investigation;
* Support the Supply Chain function in the selection and implementation of new subcontractors and alternative suppliers of strategic materials, in order to optimize development times and costs and/or guarantee the adequate level of compliance.
Requirements:
* Degree in Chemistry, Chemistry and Pharmaceutical Technology, Pharmacy, Biology, or a related field.
* At least three years of experience in the field, both for QA and regulatory aspects, is recommended.
* Previous experience in managing aspects of the Quality Management System with particular reference to change management will be an advantage.
* Excellent written and verbal communication skills to effectively interact with various departments and regulatory authorities.
* Ability to manage complex and detailed documentation with a high level of accuracy.
* Fluent in English, both written and spoken.
Company:
Alfasigma is a pharmaceutical company, born in 2015 from the merger of two historic Italian companies. It is among the top five pharmaceutical companies operating in the Italian market and boasts a growing international presence, with branches in 24 countries. Alfasigma's goal is to improve the quality of life of patients, caregivers and healthcare professionals working with passion and strongly believing in its mission.
In the last 12 months, Alfasigma has acquired Intercept Pharma in the US and Galapagos' commercial group with an ambition to develop specialty, gastrointestinal and rare disease medicines.