Regulatory Affairs Expert

Regulatory Affairs Expert

Catalent

Limoges, France

The role

The incumbent supports clients in the strategy of preparing and submitting the CMC part of regulatory files (IMP, IND).

He ensures the drafting of registration files for experimental drugs in coordination with the customer, the development, operation and site quality departments in compliance with regulations.

  • Advises clients on strategies for preparing and submitting CMC registration dossiers;
  • Evaluates and propose the most appropriate regulatory registration strategy for clients;
  • Authors the modules of the regulatory files (EMA, FDA procedures;
  • Prepares answers to questions from administrations;
  • Guarantees the regulatory compliance of documents drawn up according to the guidelines and regulations in force while integrating the industrial constraints of the site;
  • Works in partnership with the development, operation, and quality departments in order to integrate the technical and industrial constraints of the site's manufacturing processes;
  • Ensures regulatory and scientific intelligence (EMA, FDA, and other countries) to ensure the compliance of drafted documents;
  • Supports the development department for the identification of regulatory constraints in the development/feasibility phase;
  • Writes the procedures inherent to its activity.

The candidate

  • Pharmacist, doctorate, or engineering degree with a specialization in regulatory affairs and/or a university degree mainly in regulatory affairs;
  • At least 5 years experience in a regulatory affairs department;
  • At least 3 years of experience in regulating organic products;
  • Proficiency of the various European and American laws applicable to drugs, experimental drugs and biological products for the early phases of development as well as for the late phases and registration;
  • Knowledge of drug development phases;
  • Knowledge of biological and sterile products;
  • Knowledge of regulatory requirements for gene and cell therapies will be appreciated;
  • Knowledge of the regulations for medical devices will be appreciated;
  • Proficiency in authoring the registration modules files in English;
  • Excellent writing skills;
  • Solves complex problems, takes a new perspective using existing solutions;
  • Knowledge of Quality-by-Design / Quality Risk Management approach;
  • Team spirit;
  • Force of proposal strength;
  • Autonomy;
  • Synthesis capacity;
  • Rigor;
  • Communication knowhow.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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