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Jobs.mom Israel

VP International Markets Regulatory Affairs

Israel Jobs

Israel Jobs

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Tel Aviv-Yafo, Israel

Job DescriptionThe VP, IM, Regulatory Affairs role is responsible for leading, managing and motivating the various International Market (IM) regulatory affairs teams, including the local IM market RA teams, as well as indirect oversight and support of the IM Specialty and Biosimilar regulatory teams in order to receive >100 MA approvals per year. Reporting to SVP Global Head of RA, this position will fully develop the IM Regulatory strategy and implementation plan to align with the broader Global Regulatory Affairs Vision. IM Regulatory Affairs operates within the following environment: Projected sales for 2022 IM AOP: Specialty 266m, OTC 450m, Gx 1,042m, LLP 193m, other 78m (c2B$); Number of Submissions per year: >100 new applications per year and maintenance and management of c6,000 approved applications and c550 pending applications; Number of approvals per year: >100.Key Responsibilities A key challenge of this role is to deliver on time approvals of product opportunities in order to meet commercial needs. The IM RA team is the owner and champion of regulatory strategies and the regulatory submission dossier quality, working with all relevant parts of the business to deliver these. Work in close collaboration with Global Specialty, Global Biosimilars and EU Gx RA, to ensure the successful compilation and filings of applications (both internally developed products as well as third-party / business development opportunities), as well as to maintain compliance with regulations. Fully develop the IM Regulatory strategy and implementation plan aligned with the broader Global Regulatory Affairs Vision. Review the organization structure in total for new submissions and post approval management to assess and determine the new operating model. Build a team with strong capabilities and experience. Ensure pro-activity and leadership, transparency, trust, teamwork and collaboration. Integrate all teams’ activities, harmonize and improve internal processes and working practices, improve business-wide communication and integration with all functions. Collaborate with product development sites and business development partners to ensure submission and approval of high quality regulatory applications. Ensure communication of new regulatory requirements and/or review trends to affected functional areas such as R&D, Quality, Operations, Sales and Marketing, and Portfolio Management. Coordinate/manage the interactions with regulatory authorities and represent the company with such authorities as appropriate. Coordinate/manage the activities of regulatory affairs personnel within scope of role, consultants etc. involved in the preparation of regulatory applications leading to new submissions, post approval change supplements, annual reports, etc., to assure on-time approval and launch of products. Develop and implement regulatory procedures consistent with local regulatory requirements. Establish and manage communication procedures and reporting for the IM RA team. IM RA AOP is part of incumbent’s KPIs. Ensuring, with IM Commercial and other functions, we meet the new launches target AOP and LRP (Regulatory strategy, DL's management, MA approvals, post approvals variation etc.), and avoid stock out (change management, regulatory compliance, variations etc.). Education & Knowledge 15-20 years significant experience of pharmaceuticals regulatory affairs. Previous experience re/organizing and managing teams of regulatory professionals. Significant experience managing regulatory affairs activities, including a demonstrated depth of submission and approval management. Demonstrated experience of contact and relationships with senior staff and Project Managers. FunctionRegulatory AffairsSub FunctionMedical Regulatory AffairsReports ToSVP, Global Regulatory AffairsAlready Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Teva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.