Manager/sr Manager, Regulatory Affairs Cmc

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**:
Job overview/summary
- CMC Regulatory Affairs (Senior) Manager while being a part of Global CMC RA organization serves as CMC RA Affiliate for assigned products and territories who through partnership with Global teams and full integration in RA Affiliate, design and execute CMC RA strategies that align PDM's (Pharmaceutical, Development, Manufacturing) CMC objectives with Affiliate's business goals.

Job responsibilities
- In this role for your assigned markets/regions you will- Ensure CMC part of the regulatory submissions meets ICH and regional/local regulatory requirements.-
- Ensure and lead timely discussion, and negotiation as necessary, with local/international health authorities regarding responses to CMC questions and work with international/local colleagues to ensure consistency of responses in alignment with ICH and TGA Guidelines. Author and submit the responses to the health authorities with a sense of urgency.- Perform document filing and retrieval functions as directed, or with departmental SOPs and work instructions.- Perform workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to key stakeholders.- Perform CMC change control assessments against local regulations, guidance, and best practices.- Frequently interact and collaborate with colleagues outside of CMC RA to define strategy and filing plans (i.e. Regulatory Affairs, Quality Assurance, Manufacturing Sites, Supply Chain and Commercial), including anticipation of regulators questions and responses.- Contribute to global filing strategy by providing local/regional expertise in CMC regulatory requirements and filing mechanisms with optimally innovative, risk-based approaches including identification of CMC risk areas and development of alternative courses of actions.- Contribute to regulatory strategy and filings outside of the assigned market(s).- Contribute to local/regional/global process improvements, which have an impact on the working of the CMC Regulatory Affairs function or other functional areas.- Perform regulatory intelligence by keeping abreast of CMC registration requirements and best practices, assessing impact on the current and future fillings and communicate to stakeholders on a timely basis.- Follow knowledge sharing practices using designated knowledge management tools and processes.- Understands and guides relevant stakeholders and project teams on potential or actual impact of regional/local circumstances including cultural, economic, and social factors.- Ensure regulatory conformance and consistency for assigned products in compliance with regulatory requirements and internal procedures.- Ensure CMC changes with impact on labeling are communicated to the relevant stakeholders responsible for preparation and maintenance of country specific labeling.- May participate or lead updating and preparing the department for minor changes in legislation.- May be assigned as a mentor or may support training of other colleagues on the team.- May serve as International Product Lead on Global Project Teams.

Skills and Competencies- Capable of developing and implementing optimal regulatory strategy and being a role model in the strategy execution.- A proven ability to author and co-ordinate preparation of a variety of CMC regulatory documents in collaboration with other functions.- Strategic prioritization and implementation of risk-based approaches that includes analyzing, prioritizing, and mitigating regulatory risks.- Excellent organizational skills and ability to work on and/or oversee several products/markets simultaneously and with tight timelines.- Excellent verbal and written communication skills focused on delivering the right message to the right audience with an ability to convey information effectively with respect an