Director of Regulatory Affairs Biotech

We are mandated to help find a Director of Regulatory Affairs for a Biotech that starts to work on the New Drug Application (NDA) they intend to submit to the FDA in 2022.

You will be joining a biotech that announced positive result on the safety and efficacy for their Phase III clinical study. Therefore, they are in the process to submit the NDA to the FDA.

The role will provide the opportunity to contribute significantly to and often lead the team that is assembling for this submission effort.

As Director of Regulatory Operation, you are responsible for overseeing the Regulatory matters from the planning, coordination at a cross-functional level as well as the submission. You will be involved in the end-to end process, that will give you a full overview and such diversity.

Moreover, this is an opportunity to register a new drug on the market that will benefit thousands of patient.

Your tasks:

· Create and Manage the submission plans and ensure the coordination at a cross-functional level to drive timelines.

· Plan, coordinate and manage the internal and external preparatory meetings. 

· Manage the resource needs to defined budgets for Regulatory Operation, including the Management of external vendors for outsourced activities.

· Be the point of contact of the Health Authorities in order to respond to their questions.

Collaborate with Head of development and the R&D team regarding the regulatory matters.

Your experience:

· A minimum of 8 Years of experience in Regulatory Affairs in the Biotech/Pharmaceutical industry.

· Demonstrated knowledge of FDA and ICH regulation, including knowledge of the drug development process and experiences in IND and NDA regulatory Submissions.

· Experience in analyzing and developing strategies for Regulatory Submissions, compliance issues and clinical development.

Being part of the registration of a new product on the market is always a specific milestone for the patient, the people who participated in the development as well as the patient. You will play a big role, knowing the company has 6 other molecules in the pipeline, this can open an exciting future.

Contacts :

You can contact me directly via Linkedin or send me your application to have a confidential conversation together.