Regulatory Affairs Specialist-CMC

Fecha:  22-jul-2022
Ubicación:  SAB0 - PHARMA SANT ANDREU DE L

Mission

Within the Regulatory Operations Department, we are looking for an experienced CMC Regulatory Affairs Specialist.
The mission associated to this position is:
-    To define the strategy, regulatory procedures and requirements of Almirall Global products (biologics and chemical) from a Quality perspective (CMC modules of the dossier) for obtaining and maintaining Marketing Authorizations (MAs) according to the local regulations in any territory.
 

Functions & responsibilities


•    Solve the preliminary queries and evaluate from a regulatory perspective the formal changes proposed by the Industrial Operations Area using the Change Control system of the company.
•    Participate as an expert in regulatory CMC matters concerning both chemical and biologic products in meetings with other departments, external companies and health authorities.
•    Obtain the necessary CMC documents and compile the dossiers for regulatory procedures, ensuring they are presented to partners, market companies and health authorities within the established deadlines.
•    Monitor CMC 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.
•    Supervise CMC activities carried out for regulatory purposes through consultants, CROs, local agents and partners.
 

Education

•    International regulatory affairs legislation in CMC topics and procedures for biologics and chemical products in both EU and non-EU Regulatory Agencies.
•    Pharmaceutical development, Analysis, Production and Quality Control in chemical and biologic products, from development to post-marketing phases.
•    High level of English.
•    Team player with ability to communicate effectively across several scientific disciplines.
 

Experience


•    5-10 years of experience in Regulatory in the field of CMC.
•    Extensive experience in interaction with Regulatory Agencies.
•    Previous experiences in dermatological products will be valuable.