Oxford Global Resources is looking for a regulatory affair professional to collaborate with a pharmaceutical multinational company for a 4 months project, likely to be extended.
Functions
Responsible for the implementation of global regulatory strategy and ensuring support to Marketing Authorisation submissions, approvals, and license maintenance in accordance with agreed regulatory strategies.
Supports the implementation of the global regulatory strategy for a product/group of products.
Contributes to the creation and maintenance of the Regulatory Affairs quality system collaborating to the definition of processes and implementation of global standard procedure.
Collaborates in the preparation and/or revision of global regulatory submissions (EU or International countries) to ensure they are complete, accurate and consistent with company objectives and in line with the latest local regulations.
Lifecycle management of drug products.
Preparation of documentation and submissions to Health Authorities, directly or with the contribution of local partners in compliance with current legislation to ensure efficient registration and maintenance of the registrations in accordance with business strategies.
Supports the labelling and change control processes to ensure timely and comprehensive review and approval of all packaging components (e.g., cartons, labels, Physicians Inserts, Patient Inserts, and Medical Guides).
Manages any other legal documentation required such as CPPs.
Inputs regulatory intelligence, requirements and submission data into relevant systems/databases and maintains data accuracy.
Maintains accurate and up to date regulatory files.
Maintain up-to-date knowledge of regulatory requirements and communicate changes in regulatory information to stakeholders and senior management in a timely manner.
Requirements
Minimum 1-2 years of experience in Pharmaceutical Industry.
Good knowledge of EMA, ICH and FDA regulations, guidelines, and regulatory processes regarding to drug development, approval, and maintenance of marketing authorisations.
Familiarity with eCTD submission, compilation, and publishing using specific tools.
Good commercial and product awareness.
Sound administrative and systems background.
Ability to develop good cross-functional working relationships and tactical coordination of projects.
Fluent in English, spoken and written.
Requirements
4 months project likely to be extended.
Salary according to skills and experience of the candidate
Onsite position. Location: Alcobendas
