Company
INITS is a dynamic consulting firm driven by quality and innovation, dedicated to supporting biotechnology companies in delivering life-changing medicines to patients.

Specializing in pharmaceutical development, INITS provides expertise in CMC (Chemistry, Manufacturing, and Controls), IMP (Investigational Medicinal Products), regulatory affairs, quality assurance, and audits.

To support its growing business, INITS is recruiting a Regulatory and Pharmaceutical Development CMC Consultant (M/F/X).

Responsibilities
As a Regulatory and Pharmaceutical Development CMC Consultant at INITS, you will play a key role in supporting our clients throughout the development phases of their pharmaceutical products. Your main responsibilities will include:

• Consulting and Guidance: Provide technical and strategic advice on CMC activities, ensuring compliance with regulatory requirements and industry best practices. Guide and advise clients on regulatory procedures and timelines. Manage regulatory submissions in the EU on behalf of clients for scientific advice or dossier submissions.

• Drafting Quality Documentation: Actively contribute to the drafting and review of scientific advice dossiers and quality sections of regulatory files (IMPD, IND, CTD, etc.), ensuring accuracy and precision.

• Project Management: Coordinate and monitor the various stages of projects in collaboration with internal and external teams while ensuring deadlines, budgets, and objectives are met.

• Reporting and Communication: Develop tracking and reporting tools and maintain clear and regular communication with stakeholders regarding project progress.

You will be a trusted partner for our clients, actively contributing to the success of their projects and the quality of the products delivered to the market.

Profile

• At least a Master’s degree in pharmaceutical sciences (M2 level) or a pharmacy degree.

• A minimum of 6 years of experience in pharmaceutical development and drafting quality sections of regulatory documents.

• Proven experience in pharmaceutical development, process validation, and biologics production (USP & DSP) and/or finished product manufacturing processes.

• Strong knowledge of technical and regulatory guidelines (ICH, Europe, US) and the ability to stay updated on new developments.

• Excellent project management skills, proficiency in Microsoft Office, and fluency in English.

• Organized, rigorous, and capable of working autonomously and as part of a team. Strong interpersonal and communication skills.

Employment Conditions

• Competitive salary based on experience.

• Benefits: Performance-based bonus, 80% coverage of health insurance, employee savings plan (PEE), and more.

• Location: Montpellier, with remote work options available.

Join the INITS adventure today!