Requirements: English
Company: Medincell
Region: Montpellier , Occitanie
Junior Regulatory Affairs Specialist (M/F)- CDD 12 months
Medincell is a commercial-stage pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Products of our portfolio are based on our BEPO® technology and aim to ensure patient compliance, improve the effectiveness and accessibility of treatments, and reduce their environmental footprint. We collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.
We are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs team which main mission is to ensure that all products meet the necessary legal and regulatory requirements, facilitating their approval and market entry.
The successful candidate will be responsible for managing and coordinating regulatory submissions, ensuring compliance with industry standards, and maintaining up-to-date knowledge of regulatory requirements.
Missions
- Coordinate with cross-functional teams to gather necessary information for regulatory submissions (meeting requests, rehearsals, briefing book preparations, and meeting minutes).
- Oversee the preparation and maintenance of regulatory submissions and files for the US and EU (IND/CTA).
- Perform Quality Control (QC) of regulatory documents.
- Manage electronic submissions to FDA, EMA, and MHRA in the appropriate format.
- Manage and archive documents while maintaining internal regulatory databases to ensure accurate and up-to-date records.
- Stay up to date with FDA, EMA, and MHRA regulations, guidance documents, and ICH guidelines.
- Provide regulatory support during inspections and audits.
- Perform quality control (QC) of documents to ensure accuracy and compliance.
Profile
- Masters degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology, Biotechnology).
- Minimum of 2 year of experience in regulatory operations within the pharmaceutical or biotechnology industry.
- In-depth knowledge of regulatory submission processes and requirements.
- French and Fluent in English, spoken and written ability to attend meetings and write clear reports.
- Strong organizational and project management skills.
- Excellent communication and interpersonal skills.
- Proficiency in electronic document management systems and regulatory information management systems.
- Experience with global regulatory submissions (US, UE UK)
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Strong problem-solving skills and attention to detail.
Competitive package composed of:
💼 Competitive Base Salary
💰 Bonus and Profit Sharing
🍽 Lunch vouchers (9 per day, 60% paid by the company)
🏋 Sport and yoga sessions onsite available 4 times a week
🎉 Monthly socializing events
🕒 Very flexible working hours and home office policy
Medincell is an equal opportunity employer welcoming applications from all individuals, including those with disabilities.