Associate Director, Regulatory Affairs CMC

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

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

Job Description

At Gilead, we’re committed to creating a healthier world for everyone – no matter the challenges ahead of us. For more than 30 years, we’ve pursued the impossible, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases.

Through bold and transformative science, we’re driving innovation that has the potential to become the next generation of life-changing medicines. Our ambition is evident in our mission. Because the impossible is not impossible. It’s what’s next.

Gilead is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s primary therapeutic areas of focus include Viral Diseases, Inflammatory Diseases and Oncology.

We have an opportunity for an Associate Director, Regulatory Affairs CMC who is passionate about advancing therapeutics against life-threatening diseases and thrives under pressure. The successful candidate will manage a small team of regulatory professionals providing CMC regulatory support for new marketing applications and post-approval regulatory filings across International Rest of World regions, including Asia, Latin America, Middle East, Eastern Europe and Africa.

RESPONSIBILITIES

• Line management of a small team of Regulatory CMC professionals.

• Work with Pharmaceutical Development, Analytical, Manufacturing and QA teams to prepare the Quality sections of new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for submission in International Rest of World markets. Ensure dossiers meet ICH and local regulatory requirements.

• Act as the regional Regulatory CMC lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the International Rest of World markets.

• Liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.

• Co-ordinate regulatory assessments for post-approval CMC changes, develop filing plans for assigned markets and execute filings according to agreed priorities.

• Maintain a current awareness of CMC registration requirements in each of the International Rest of World regions and communicate key regulatory intelligence to the organization on a timely basis.

KNOWLEDGE, EXPERIENCE AND SKILLS

• BA/BS, MS or Ph.D or equivalent education.

• Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience.

• Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products.

• Drug-device combination product experience would be an advantage, but not essential.

• A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.

• An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.

• Experience representing CMC regulatory affairs on regulatory teams.

• The successful candidate will have a broad understanding of pharmaceutical manufacturing, change control, and distribution systems.

• Excellent written and verbal communication skills.

ABOUT GILEAD REGULATORY AFFAIRS

Within the department there lies a strong sense of teamwork with a friendly and supportive atmosphere. Personal and professional development is actively encouraged and supported.

You will need to be task orientated and be prepared to work under pressure. You will be directly involved in writing and preparing regulatory documentation.

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.