Director CMC Policy, Advisory and Intelligence

Описание вакансии

The Director, CMC Regulatory Affairs Policy, Advisory and Intelligence is part of a team of recognized experts both inside and outside the business, who are collectively responsible for leading various aspects of internal and external-facing advocacy as applicable to support the Gilead portfolio. This leader will represent the business externally and will be focused on influencing, while working with the team and other stakeholders in developing and advocating policy positions (internally and externally) in the CMC regulatory sphere. The role will be focused on the North American policy landscape and will be responsible for positioning Gilead’s products/ portfolio for regulatory and technical success, contemporizing processes as needed, and supporting the holistic global harmonization of marketing applications. They will be accountable for consulting with project teams on the implementation of ICH and other appropriate technical regulations and guidelines. This position will require a strong and extensive external network as well as excellent communication, influencing and collaboration skills, as well as the ability to quickly digest, understand and communicate highly complex regulatory issues to a variety of stakeholders. The team member will also be responsible for interacting with multiple internal and external stakeholders to ensure that dossiers as written meet Health Authority guidance and have clear messaging. The role will report directly to the Head of Policy, Advisory and Intelligence/CMC Regulatory Affairs.

JOB DESCRIPTION

• Serve as critical and recognized, internally and externally, thought leader and contributor to the CMC Regulatory Affairs Policy, Advisory, and Intelligence Office at Gilead Sciences.

• Lead, coordinate, and as needed, represent the business in ICH, trade associations (eg PhRMA), workshops, etc., with minimal oversight.

• Bring a strong North American focus into the development of Gilead’s global CMC regulatory policies and priorities.

• Develop and implement solutions for global and far reaching regulatory complexities and challenges, using a high degree of creativity, innovation and ingenuity.

• Present and articulate complex issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentor and share experience with colleagues.

• Facilitate and support project teams’ identification of science and risk based solutions for precedent-setting project issues and enable their understanding of local (North American) regulations and requirements.

• Contribute to the strategic direction of broad global harmonization efforts and enable new technologies and innovative approaches– with the focus of benefiting Gilead’s scientists.

• Build/maintain trust and establish a strong and effective network with relevant external partners, including global regulatory authorities, nonprofit organizations, and academic institutions, with specific focus on FDA and cross industry associations.

• Matrix/coordinate/lead strategy development with Quality Policy-Intel group/ Gilead Policy.

• Develop and implement external strategies for Gilead’s critical and precedent-setting initiatives (new technology, complex projects).

• Serve as the policy point of contact for select partners and stakeholders and communicate timely and relevant information/knowledge sharing.

• Independently lead key implementation efforts and highly significant projects to ensure Gilead’s participation in multiple external forums addressing the development of global regulatory guidance.

QUALIFICATIONS

• A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 12 years with a BA/BS, 10 years with a MA/MS, or 8 years with a PhD, PharmD, or MD.

• Demonstrated track record in impacting global CMC regulatory affairs, developing innovative CMC regulatory strategies, and leadership in multiple international regulatory/industry forums for topics of external policy relevance.

• Expert on guidelines and regulations, with a desired focus on North American aspects (eg PhRMA, FDA).

• Strong knowledge of ICH guideline interpretation and implementation, previous ICH experience is highly preferred

• Demonstrated organizational leadership skills at the functional level.

• Excellent strategic acumen, collaboration, and communication skills are required.

Gilead Core Values

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.