Associate Director, Regulatory Affairs CMC

Associate Director, Cmc Regulatory Affairs For Biologics

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.

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At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

As an Associate Director, Cmc Regulatory Affairs For Biologics, at Gilead you will be responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position will ensure "right first time" global approvals of Cmc regulatory (Biologics) submissions, and "right to operate" by maintaining the global clinical or commercial submissions. In addition, you will be accountable for leading the interpretation and implementation of Cmc regulatory guidelines, regulations and current environment to assure approvability in high priority regions. As a regulatory lead you will also be responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing (Pdm) Project teams.

Specific job responsibilities:

• Ensure that Cmc dossiers meet Ich format and content requirements, as well as the specific local requirements of individual countries. Takes a leadership position in conducting risk assessments on major global Cmc regulatory issues.
• Must be pro-active in staying current with registration requirements in each of the applicable regions, and must communicate this information to the corporation on a timely basis.
• Play a leadership role on project and other teams in developing global Cmc regulatory and change control policies and strategies.
• Work proactively to build contacts with local Health Authorities, and to present a positive image of Gilead in all discussions with Health Authorities.
• Responsible for ensuring timely discussion with Health Authorities regarding responses to questions, and will work with international colleagues to ensure consistency of responses to international Health Authorities.
• On a regular basis, participate in significant industry trade groups and regulatory professionals associations.
• Take a leadership role in updating the corporation on major international Cmc regulatory guidance.
• Will be expected to use industry network to maintain an awareness of the "pulse" of Cmc best practices, and to disseminate this information to the corporation.
• Form ad hoc task forces to address critical Cmc issues on behalf of project and department teams
• Excellent verbal and written communication skills and interpersonal skills are required.

Regulatory strategy:

• Facilitate good communication and transparency of Cmc information to relevant functions.
• Provide consistent, high-quality Regulatory Cmc input on Cmc issues and risks along with mitigation plans/options.
• Lead and coordinate development of regional Regulatory Cmc strategy, Cmc submission content and timing to ensure alignment as outlined in the global regulatory strategy document.
• Ensure the Regulatory Cmc strategy includes input from all geographies, commercial strategy and supports the Target Product Profile. Refine the Regulatory Cmc strategy and updates as new data becomes available or as necessary.
• Liaise with Rpt members to prepare Cmc updates and/or regulatory position papers for consideration by the Research Project Review, Development Project Review and High Level Management, as necessary.
• Coordinate the provision of Regulatory Cmc input on key milestones and stage gate recommendations, as necessary.
• Develop Cmc lifecycle management plans with input from Rpt.

Health authority interaction:

• Coordinate and facilitate development of regional Regulatory Cmc strategy with affiliate for local meetings.
• Provide strategic input to meetings with Regional Health Authorities to ensure alignment with the global Regulatory Cmc strategy. Participate in regional meetings support regional heads, as necessary.
• Provide input to all Cmc briefing documents and other supporting documentation. Regional Cmc personnel are responsible for authoring and presenting Cmc documentation to their Health Authorities.
• Provide high level feedback to Senior Cmc Management on points of discussion with Regional Regulatory Authorities that may impact globally (detailed minutes are communicated by the Regional Regulatory Leads).
• Work with the regional Cmc personnel to develop a Cmc submission plan in accordance with business objectives.
• Complete final review for all major and/or critical Cmc submissions (Nda, Maa, Nds, Pas, Cmc briefing documents, requests for Scientific Advice, Drug Product Listings and Site licenses as appropriate) and Cmc responses to Health Authorities.
• Establish a Cmc Core Rapid Response Team to facilitate the development and finalization of responses by the regional Cmc personnel, as necessary.

Regulatory input into other functions:

• Directly interface with the Regulatory Project Team and represent the affiliate's regulatory viewpoint at such meetings.
• Support meetings and activities of the Regulatory Submission Team (meetings are chaired by a Regulatory Project Manager).
• Act as a "champion" of the Regional Cmc Regulatory viewpoint.
• Work with Rptl to direct, manage and resolve Cmc issues regarding the implementation of the global Regulatory Cmc strategy.
• Work with the Rptl to provide Cmc input for the Target Product Profile, and labeling (including Package Insert/Smpc/Product Monograph), as necessary. Regional Cmc personnel are responsible for a Final Review and Approval of regional label.
• Coordinate the provision of global Regulatory Cmc advice to Pdm, Qa and Commercial Manufacturing organizations.
• Provide input from a global perspective on the Cmc data required to support a clinical development program (based on input from the regional Regulatory Cmc personnel).
• Lead the development of the Regulatory Cmc strategy, content, and submission timelines in accordance with business objectives.
• Ensure provision of global Regulatory Cmc input into Clinical, Commercial and Development sub teams, as necessary.
• Conduct in-licensing due diligence, as necessary, for project(s) evaluation and life cycle development.

Resource planning:

• Define and highlight regional / global Regulatory Cmc resource issues that may affect the implementation of the Regulatory Cmc strategy etc, as necessary.
• People relationships & communication2
• Cross-functional team leader responsibilities.
• Facilitate good teamwork across affiliates and sites.
• Ensure cross-regional communication and transparency in the flow of Cmc information that may affect regional regulatory strategy.
• Elevate Cmc issues and potential risks, along with possible resolutions, to senior management especially when such issues impact the approvability of submissions and/or product launch.

Decision rights:

• Create an integrated global Regulatory Cmc strategy based on input from the regional Cmc personnel. Regional Regulatory Cmc personnel (in conjunction with the regional regulatory heads of department) are responsible for the definition of an appropriate regional regulatory strategy which is consistent with the global regulatory strategy.
• In exceptional circumstances, Rcptl may make decisions on the global Regulatory Cmc strategy that have an impact on the regional regulatory strategy or submissions (e.g. where timelines are exceptionally tight and there is no opportunity to seek regional regulatory input). However, all decisions on the global Regulatory Cmc strategy are typically made following consultation and agreement with Cmc Management and Rpt.
• Ensures that the strategy for meetings with regional regulatory authorities is consistent with the global regulatory strategy.
• In conjunction with the regional Cmc personnel, finalize Cmc submission plans.
• Ensure alignment of Cmc submission plans with Commercial, Clinical & Ip.

Specific education & experience requirements:

• Advanced degrees including PhD and MS desired. Relevant industry experience is preferred.
• 10+ years of experience in Regulatory Affairs or relevant industry experience