Senior Director, CMC Regulatory Affairs Policy, Advisory, - Cambridge, Cambridgeshire, United Kingdom - Gilead Sciences, Inc.

Description

Senior Director, CMC Regulatory Affairs Policy, Advisory, & Intelligence page is loaded

Senior Director, CMC Regulatory Affairs Policy, Advisory, & Intelligence

Bewerben locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Vor mehr als 30 Tagen ausgeschrieben job requisition id R

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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.We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.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. Join Gilead and help create possible, together.

Job Description

KEY RESPONSIBILITIES

The Senior Director, CMC Regulatory Affairs Policy, Advisory and Intelligence is a recognized expert both inside and outside the business, and is 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 developing and advocating policy positions (internally and externally) for CMC regulatory issues in conjunction with the Gilead Quality Policy Office. The role will be focused on the European 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 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 Global 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 (e.g., EFPIA), workshops, etc., with minimal oversight.
• Lead development of Gilead's global CMC regulatory policies and priorities, with a focus on Europe-facing assets.
• 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 solutions for precedent-setting project issues and enable their understanding of local (European-facing) regulations and requirements.
• Contribute to the strategic direction of broad global harmonization efforts and enable new technologies – 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 European health authorities 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
• 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 focus on those that are Europe-facing (EFPIA).
• 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)

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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