International Regulatory Affairs Manager

INTERNATIONAL REGULATORY AFFAIRS MANAGER

Job Description
Be updated and update the company on regulatory requirements of international markets (i.e. APAC, US, Latin America etc); Support customers and company affiliates in regulatory evaluations; Support Management and CCO in evaluating new business opportunities from a regulatory standpoint and in defining regulatory strategies for new products and new businesses; Coordinate with customers and company affiliates for the submissions of existing products or new products in international markets; Draw up the dossiers in different formats (e-CTD, US format etc) and the required regulatory documentation to support registration of medicinal products in international markets; Prepare answers to Deficiency Letters, IRs, CRLs and any other request from regulatory authorities on the existing and new products under registration in international markets; Maintenance of licenses/authorizations for existing marketed products in international markets; Support customers and affiliates in life cycle management of the products; Identify & prioritize key areas of risk and develop & implement appropriate mitigation plans and area of improvements; Perform gap analysis on regulatory documentation and propose solutions if required.
Education/Experience
Bachelor degree in pharmaceutical field (Pharmacy, Pharmaceutical technology or other); Min 5 years of experience in RA or related field; Experience working in a pharmaceutical company with sterile injectable products; Deep knowledge of international regulatory requirements including marketing authorizations submissions and maintenance activities; Strong scientific knowledge; Experience in eCTD and other dossiers'formats writing.
Location: Milan