Regulatory Affairs Senior Manager
Famille de fonction : Affaires réglementairesDescription du poste et des missions
WHO WE ARE 🧬
Cellectis is a global clinical-stage biopharmaceutical company. Pioneers and innovators in our field, our mission is to develop innovative treatments for patients with unmet medical needs.
With 25 years of expertise, we have the best-in-class gene editing platform focusing on immuno-oncology, and gene therapy. Through our efficient and precise TALEN® technology, we create allogeneic CAR-T cells capable of recognizing and combating cancer cells.
Today, our three clinical programs target patients with B-cell acute lymphoblastic leukemia (B-ALL), non-Hodgkin lymphoma (NHL) and acute myeloid leukemia (AML).
We are fully integrated and a leader in end-to-end gene editing, allogeneic CAR T-cell companies. With our in-house manufacturing, we control our gene and cell therapy process from start to finish with starting materials produced in Paris (France) and CAR-T therapy products created in Raleigh, NC (USA).
We also have several ongoing strong collaborations, based on our TALEN® technology, with leading cell & gene therapy companies, including our recent partnership with AstraZeneca, to develop new product candidates in oncology, immunology, and treatment of rare diseases.
At Cellectis, we are committed to a cure.
WHY JOIN US?
At Cellectis, our strength as a global organization lies within the collective diversity of the backgrounds, experiences, cultures and perspectives of our colleagues and teams.
We are ONE team of more than 230 employees dedicated & engaged colleagues working towards one mission.
We are gamechangers in the cell and gene therapy field – we invented the allogeneic approach and are the first company to create gene edited allogeneic CAR T-cells.
We constantly innovate and improve to make the best product possible. We address problems with new and creative solutions.
We are committed to an equitable and inclusive work environment where you can be yourself to reach your potential.
Ready to join us?
https://www.cellectis.com/en/careers/
Want to learn more about our technologies: https://www.youtube.com/watch?v=bZyUDbW9Pjc&t=1s
Cellectis’ headquarters are in Paris - France, with locations in New York, New York and Raleigh, North Carolina - USA. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS).      
THE JOB WE PROPOSE
Regulatory Affairs Senior Manager
Paris – 13ème
Your position & your key responsibilities:
Senior Manager, Regulatory Affairs contributes to the development and executes the defined regulatory strategy and submissions.
Senior Manager, Regulatory Affairs executes strategy for regulatory consultations (e.g. Scientific advice, FDA planned meetings), key regulatory milestones (e.g. PIP/PSP, relevant designations) and clinical trial-related regulatory activities.
Senior Manager, Regulatory Affairs reports to the Senior Director, Regulatory Affairs.
Your main activities in this role:
Manage regulatory-related global clinical trial activities, including initial and maintenance IND/CTA submissions.
Ensure that clinical studies are executed in compliance with regional and local regulations, prepares the regulatory and coordinates scientific documentation writing for the regulatory filings, contributes to the authoring of supporting documents and the review of regulatory processes and guidelines.
Support preparation and review of scientific documentation for regulatory filings (including IBs, IMPDs, protocols and amendments, safety reports, annual reports, labelling).
Represent Regulatory Affairs at cross-functional team meetings, providing input on the regulatory aspect of product development.
Prepare regulatory documentation, including briefing documents for meetings with regulatory authorities, orphan drug applications, applications for relevant designations/accelerated development programs, PIPs/PSPs.
Contribute to the definition and execution of the regulatory strategy.
Contribute to the maintenance of quality standards in regulatory affairs activities, working closely with Quality Assurance and Regulatory CMC functions.
A word from the manager / the team of the team about the job or team spirit:
“This is an exciting opportunity to join a team of highly motivated and dynamic professionals and to provide your valuable contribution to the development of the innovative therapies aiming to address unmet medical needs.”
WHO YOU ARE
Your Technical Skills Requirements / Core Competencies and leadership skills:
Good organizational skills with excellent attention to detail.
Strong interpersonal and communication skills, ability to work in a fast-paced, multi-disciplinary environment.
Strong knowledge of the current European and US regulations, laws, guidelines and industry requirements. Knowledge of the relevant guidelines relative to cell and gene therapies is beneficial.
Show a constant focus on improving performance and excellence, demonstrate agility.
Your Education, Certifications and Experience
Degree in Pharmacy, Medicine, Life Sciences or equivalent.
5+ years of relevant experience in Regulatory Affairs, including preparation, submission and managing clinical trial applications in Europe and INDs in the US, marketing authorization applications in the EU and in the US. Experience in Oncology/Haemato-oncology therapeutic area is beneficial.
CONDITIONS WE OFFER
Innovative projects and a collaborative working environment.
Motivating remuneration based on SMART annual targets.
3 home office days /month.
An onsite company restaurant.
A modern, pleasant working environment with a relaxation area, gym, terraces, vegetable garden, etc.
A very active CSE offering numerous benefits to employees (in-house media library, seated massages, culture and sport subsidies, etc.).
Regular internal events.
