Regulatory affairs - global product lead
Our client is a multinational pharmaceutical company with a portfolio that includes both innovative and established products.
For the Italian affiliate, we are currently looking for:
Regulatory affairs - Global Product Lead - New Products
This role will spend about 25% of its time being a local Regulatory affiliate representative, being the primary point of contact for the Italian team and keeping oversight of the Italian local activities. It will also provide support to the existing portfolio of products, working closely with the LCM team, in-country regulatory partners, and Local Health Authorities.
Key responsibilities (In Points):
New Submission / In-Licensing Support:Provide support and guidance to the Business Development & Licensing Team when evaluating new projects primarily for EU, UK and Canada
Prepare Regulatory submission strategies globally, conduct dossier due diligence and identify timelines for all new projects that have been identified by the Corporate BD&L team and which are to be reviewed and approved by senior management
Timely preparation and submission of regulatory applications for new pipeline products, including in-licensing, product developments and registering existing products into new markets
Review/Preparation of CMC dossier sections
Direct communication with regulatory authorities to facilitate productive dialogue on all new product submissions and other relevant issues, including pre-submission steps and management of regulatory procedure (Centralised or DCP)Timely and accurate responses to all regulatory queries in relation to Regulatory Affairs – New Products group activities, including RAMA searches
Alliance Management of the relationship with all new partners and their regulatory departments to ensure timely feedback to all queries
Report on regulatory progress and issues for new products at all project team and Project Review Meetings, and to Senior Management as required
Escalate risks / issues appropriately to remove barriers to success or advise of delays and other changes which may impact the regulatory approval timeline
Propose improvements or alternative approaches to obtain improved project deliverables
Affiliate / In-country Local Italian Support:Act as liaison point between Global Regulatory Affairs function (including life cycle management) and the local Italian affiliate (Commercial, Market Access and Medical), keeping oversight of the Italian portfolio of products and being the first point of contact for any clarifications
Ensure coordination across different global regulatory functions, keeping country priority into consideration, giving the country team visibility of upcoming changes and facilitating their implementation at a local levelManage relationship and oversee regulatory activities performed by local regulatory partners, provide local strategic support as and when needed, interact with local Health Authorities when needed, keep oversight of local activities like updating of local databases, coordinate out of stock notifications on a routine basis
REQUIREMENT: Regulatory role in submission of New products in Pharma Industry (7 years +)
Experience interacting with EU regulatory authorities – Scientific advice meetings/ Pre-submission meetingsInternational Regulatory experience
Significant understanding and experience preparing Common Technical Dossiers, including CMC sections
Experience in submissions of National and European MAA (DCP, Centralized procedure)
Excellent command of both spoken and written English