ProductLife Group is looking for a Regulatory affairs CMC expert inbiologics/biotech in Romania!
ProductLife Group is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services. All ProductLife Group’s services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes.
As a result of the deployment of a new project we are now seeking a Regulatory affairs CMC expert in biologics/biotech.
We are looking for someone with proven understanding of the regulatory processes and experience in leading projects successfully, excellent organisational and interpersonal skills and the ability to work and interact smoothly within an international team. For this role we are seeking a professional with excellent communication skills in English.
◆ Management of global submissions for regulatory affairs, Biologics CMC;
◆ Development of global Regulatory CMC Strategy and Risk Assessments;
◆ Change control management;
◆ Provides a technical support and technical content in the preparation of marketing material
◆ Represents the company in forums and conferences where he/she intervenes as an expert on a subject;
◆ Proposes to the customer a strategy of formulation, validation, choice of specifications, stability plan, bio-equivalence;
◆ Analyzes and/or writes scientific Reports from the raw data transmitted by the client;
◆ Conducts training sessions in regulatory affairs CMC or in pharmaceutical development;
◆ Carries out a continuous regulatory monitoring and communicates them to the teams;
◆ Proficient in CMC writing of chemical products. Knowledge of biological/ biotech products;
◆ Innovative and problem-solving skills;
◆ Technical knowledge: ICH guidelines, EMA guidelines, bioequivalence studies and knowledge of biological products and medical devices is a plus
◆ Ability to audit dossiers;
◆ Good experience in communicating with clients;
◆ You are fluent in English for daily contacts with local and internationally.
◆ Full training on the job will be provided;
◆ Competitive salary package;
◆ Dynamic environment;
◆ International and growing company ;
◆ Health insurance;
◆ Meal tickets.