Senior Manager, Regulatory Affairs ATMP
Location
The position may be remote based across the EU, or a mixture of office and remote based.
The Role
As a Senior Manager in Regulatory Affairs, you will provide expert knowledge on exciting area of ATMP within the Global Regulatory Affairs, CMC team which forms part of our Strategic Regulatory Services Group.
The department is growing and there are excellent prospects for professional development and enhancing your skills. With a variety of new projects, we are looking to enhance the knowledge within our team with the addition of this hire. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance.
We are seeking individuals with experience in technical development, testing and manufacturing of advanced therapy medicinal products (ATMP). In particular, with cell and gene therapies experience in one of the following areas: analytical testing and characterization, control strategies, cell culture, vector production, process design/development, CAR-T cells development, stem cells development, viral or microbial gene therapies.
Responsibilities
Serve as a technical expert in development, testing and manufacturing of advanced therapy medicinal products (ATMP) and resource to ICON colleagues, and clients providing advice
Effectively manage the preparation of regulatory CMC submission documents
Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams.
Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required.
Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
Enthusiastically monitors for new regulatory requirements and shares key findings.
Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.
Education/Experience
Bachelors degree in a relevant discipline, preferably in a life sciences, or other healthcare field.
Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.
Relevant experience i.e. pharmaceutical, biologics with regulatory experience in the global environment (e.g. Europe, US, Japan, China).
Technical development, testing and manufacturing of advanced therapy medicinal products (ATMP)
Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.
Experience supporting business development activities and people management an asset.
Certification in regulatory affairs (RAC) or post-secondary institution beneficial.