Global Regulatory Affairs Manager - Europe & Rest of World (RoW)

Chaberton Professionals , a division of Chaberton Partners dedicated to the research and selection of Middle Management profiles, is currently looking for a Global Regulatory Affairs Manager - Europe & Rest of World (RoW) Job Purpose To direct activities required to ensure the initial and continued registration of allocated products, in accordance with legal requirements and business needs. This role involves managing regulatory submissions, interacting with regulatory agencies, in order to expedite approval of submissions and ensuring compliance with Italian and EU/ ROW laws and guidelines. Main Responsibilities, Activities, Duties, and Tasks • To act as primary contact with external regulatory bodies, as required to ensure appropriate input into regulatory strategy, gain rapid approval of submissions and resolve any regulatory issues. • For projects/products within area of responsibility, collaborates with Global/regional colleagues for authoring of regional regulatory strategies which meet business goals. Ensures execution of own critical deliverables as agreed with global regulatory strategy and planning, working in partnership with crossfunctional team to support inputs into product development plans. • Leads the regulatory activities for own projects and represents the regulatory function, as needed, at project team(s) • Ensures regulatory strategy and submission planning are written and executed according to plan – or oversees if delegated to vendor. • Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed. • Identifies regulatory requirements and trends across area(s) of responsibility, and provides regulatory guidance, and expertise to development team and/or higher governance bodies in these areas, as requested. • Ensures the accuracy, scientific validity and optimal presentation of documents in submissions and that they meet current best practice standards. • Carry out regulatory review of promotional material, especially if AIFA submission is needed • Support the internal functions to comply with Italian and EU regulations, including Good Manufacturing Practices (GMP) and other relevant standards. Professional Experience, Knowledge & Technical Skills • Should have a good working knowledge of the regulatory requirements in various regions (e.g. US, EU & ROW) relevant to the projects with which they are involved and demonstrate an understanding of how to obtain and develop knowledge further. • Direct experience in interfacing with relevant regulatory authorities (e.g. EMA, AIFA, and FDA). • Will be expected to work on assigned projects independently and provide guidance to less experienced regulatory professionals, and to assist with more extensive and complex projects. • Demonstrates good interpersonal skills required to build relationships with GM&RA team to obtain information required by Regulatory within agreed timeframes, and externally with partners and regulatory authorities. Location : Milan

Location: it, IT

Posted Date: 6/14/2025