Regulatory Affairs H/F Astek

Your mission (should you decide to accept it):

Your potential challenges will be various, depending on the clients' priorities. The list below gives you examples of our classic activities.

Your daily activities will be:

- Guide our client by interpreting federal, state and international regulations as they apply to products, processes, practices and procedures.
- Be responsible for product registration activities of the assigned products and will report to the Regulatory Strategy Senior Manager.
- Work in cross-functional teams with different departments (manufacturing, labs, QA, supply,...) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) in order to support the introduction of new products at our client's site.
- It is your hard work and dedication that will make our client ready to achieve new milestones and help patients across the globe.

Scope of work:

- Support regulatory submissions (CTD, BLA, NDA,...) of the products by informing site colleagues of regulatory requirements and by authoring the dossier.
- Liaise with regulatory colleagues to communicate and resolve potential issues.
- Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance of our client's portfolio.
- Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility.
- Assess post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier.
- Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals.