Manager, Regulatory Cmc
Il y a 5 mois
**Job Description**:
The Manager or Senior Manager, Regulatory CMC:
- Ensures regulatory compliance between the practices of the Cellectis sites, the regulatory files and the regulations in force such as US and EU Regulations, ICH and Pharmacopoeia.
- defines and organize the Cellectis Regulatory CMC activities.
- Is responsible for the execution of the regulatory CMC activities, specifically writing the CMC sections, CMC dossier amendments and annual maintenance of the regulatory files; in collaboration with the larger team from Regulatory, manufacturing, quality control, quality assurance, MSAT, process and analytical development, supply departments.
- Is the Regulatory Affairs representative for the Cellectis Raleigh site and Cellectis Paris site, and is the critical link between Cellectis’ Paris, Raleigh and New York City’s locations; and is also liaising with internal and external stakeholders.
This position is located at Paris office, frequent travel to manufacturing Raleigh site is required.
**Responsibilities**
The Manager or Senior Manager, Regulatory CMC is in charge the following activities:
- Providing guidance on ICH, FDA and EU CMC guidelines specifically on ATMP, keeping up to date with the latest regulatory requirements.
- Participating in short-term and long-term planning of CMC regulatory submissions.
- Coordinating and preparing responses to competent authorities’ requests related to site CMC activities with a focus on USA and European submissions.
- Evaluate regulatory impacts of changes within the change control process.
- Contribute to annual drug product quality review of Cellectis’ investigational cell and gene medicinal products.
- Reviewing internal documentation that could be included in regulatory dossiers (analytical validation protocol and report, manufacturing process validation protocol and report, comparability protocol and report).
- Participating to the definition of specifications and define CMC regulatory requirements for specific subcontractors/suppliers for some document (QTA, contract).
**Qualifications & Experience**
- Master’s degree, PhD, PharmD in life science, pharmacy or related field, or an advanced degree in engineering with related experience in biological product manufacturing.
- 5+ years of relevant regulatory affairs experience in biological products
- 5+ years of experience in the drug development, manufacturing, and/or quality management of biological products
- Experience in the development and manufacturing of Cell/Gene Medicinal Products, preferred.
- An in-depth understanding of current regulatory environment and best practices
- and post-approval submissions), planning of regulatory strategies, assessing regulatory compliance, and supporting quality systems
- A proven record of working with and influencing multi-disciplinary teams and external experts, as well as demonstrated leadership, communication, problem solving and decision-making skills.
**Core Competencies**
- An understanding and appreciation of relevant scientific and manufacturing areas
- Strong writing, negotiation, presentation, time management, problem-solving, interpersonal, communication and analytical skills.
- A flexible and creative approach to solution thinking
- Be able to work independently, and as a part of an internal or cross functional team, within a collaborative setting.
**Advantages in joining Cellectis**:
- Innovative projects and a collaborative work environment
- Motivating remuneration based on SMART annual objectives
- Customized social security coverage for you and your family
- An on-site company restaurant
- A modern, pleasant working environment with a relaxation area, gym, terraces, vegetable garde, darts and a fuzzball table
- A very active CSE offering numerous benefits to employees (in-house media library, seated massages, culture and sports subsidies, etc.)
- A green commission proposing improvements in favor of the environment
- Regular internal events
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