You ensure product compliance with local and international legal and regulatory requirements, collaborating with health authorities, preparing and submitting registration dossiers, and providing expertise on the regulatory aspects of ongoing projects. 

Your missions will be as follows: 

Registration dossier management: 

• Prepare, submit, and follow up on marketing authorisation (MA) applications for pharmaceutical products with the competent authorities (e.g. EMA, FDA, ANSM). 

• Ensure the update and management of regulatory dossiers for existing products (variations, extensions, renewals). 

Ensure that registration dossiers comply with current standards and requirements, both nationally and internationally. 

Regulatory compliance:

• Advise the company on local and international regulatory requirements regarding pharmaceutical products, clinical trials, Good Manufacturing Practices (GMP), and other regulatory aspects. 

• Conduct continuous regulatory monitoring and anticipate legislative and regulatory changes likely to impact the company's products or processes. 

Interface with health authorities: 

• Act as the primary contact for health authorities during the registration process and regulatory inspections. 

• Represent the company in exchanges with regulatory agencies (EMA, FDA, ANSM, etc.), answering their questions and providing researchers with the requested information. 

Monitoring product developments: 

• Ensure the regulatory compliance of products throughout their life cycle, particularly during changes to formulations, packaging, or manufacturing processes. 

• Advise on the management of regulatory changes, including variations, recontracting, and the addition of new therapeutic indications. 

Assistance with clinical trials and marketing: 

• Support the preparation of regulatory dossiers for clinical trials and ensure compliance with local and international requirements regarding Good Clinical Practice (GCP). 

• Participate in preparing and submitting clinical trial authorisation requests to the competent health authorities. 

Advice on regulatory strategies: 

• Develop regulatory strategies for products in development to maximise the chances of obtaining marketing authorisation and accelerate the launch process. 

• Collaborer with the research and development, marketing, and production departments to anticipate potential regulatory challenges. 

Training and awareness: 

• Train internal teams on regulatory requirements and registration processes. Raise team awareness regarding regulatory risks and the importance of compliance in the management of pharmaceutical products. 

Profile sought: 

• With a Master's degree (Bac +5) in Pharmacy, Regulatory Sciences, Biotechnology, or a related field, you have a minimum of 3 to 5 years of experience in regulatory affairs within the pharmaceutical industry, with a strong understanding of drug registration processes and local and international regulations. 

Technical skills:

• In-depth knowledge of pharmaceutical regulations (EMA, FDA, ANSM, etc.) and Good Practices (GxP).

• Proficiency in drug registration processes, clinical trials, and variations. 

• Ability to prepare and submit complete and compliant regulatory dossiers. 

Personal skills: 

• Excellent communication and relationship management skills with health authorities. 

• Rigor, organisational skills, and the ability to work under tight deadlines. 

• Ability to resolve complex regulatory issues.