​Sr Manager / Associate Director Regulatory Affairs - Swiss Affiliate

Benefits

Additional Information

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Sr Manager / Associate Director Regulatory Affairs - Swiss Affiliate Department: Regulatory Affairs Department, Gilead Sciences Switzerland Sàrl Location: Zug, Switzerland Reports to Director Regulatory Affairs Job Overview - Serves as a core member of the Swiss Affiliate Regulatory Team - Key cross functional business partner - Senior representative of the Regulatory function and Dev Ops at internal and external meetings - Ensures that Gilead complies with country's applicable legislations and regulations linked to the MA / local license as MA Holder - Ensures that the medicinal products in his/her responsibility can be developed, authorized and maintained on the market - Serves as a core member or leads cross functional project teams locally, regionally and globally. May also serve as a core member in global cross-functional teams Job Responsibilities - Provides or contributes to the Vision and Direction for the RA organization in the sub-region and / or at the country level in line with global/Regional RA and the local Affiliate Visions and sets clear goals and objectives in line with the global Dev Ops strategy - Ensure that Gilead fulfills all relevant requirements linked to the MA / local license as MA Holder or as local legal representative of the MA Holder for the Affiliate - Support to Crisis management functional lead and leadership team in the Affiliate - Contributes to resource and budget planning and utilization - Lead or support for communicating important changes to the local Regulatory and Dev Ops function/activities - Leads the preparation of challenging regulatory submissions (initial MA Applications, line extensions, scientific advice, inspections, quality assurance related issues and risk management/minimisation activities) to local HA and leads the interaction, negotiations and communication internally and externally, coordinates cross function responses and act as the main point of contact for the local HA - Lead or support country/national scientific advice and / or pre-submission meeting preparation and follow-up - Accountable for managing the strict timelines associated with submission and/or variation approval. - Ensures compliant labeling for Gilead medicinal products (SmPC, PIL, packaging) and manage timely updates for assigned product(s). Provides regulatory expertise to labelling changes and to submission teams on specified topics. - Lead or provide Affiliate input to the International and global regulatory strategy, upon request, including input into clinical development programs - Ensures compliance with local law and regulation and consistency with global procedural documents including Quality Assurance matters such as acting as a subject matter expert or audit / inspection lead within the affiliate, ensuring essential licenses, contracts and agreement are in place - Initiates local improvements and contributes to local and/or global process improvements which have a significant impact for RA and other departments, assesses proposed changes to local procedural documents, sharing of best practice and impact on existing processes - Responsible for promotional material review, submission to HA, if applicable for assigned product(s) - Serves as a core member of the country brand/launch team or international working group as the representative of regulatory affiliate. - Acts as a consultant to local Affiliate, regional, Intl or Global RA teams on Affiliate matters - Takes a leadership role in conducting risk assessments on specific local regulatory issues and changes, and develops mitigation strategies as required - A regulatory expert in updating and preparing the Company for major changes in regulatory legislation and competitor information in the country, contributes to guideline and regulation development and develops strategies to