Senior Associate, CMC Regulatory Affairs, International (Cambridge Office)

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 a Senior Associate, Regulatory Affairs CMC who is passionate about advancing therapeutics against life-threatening diseases and thrives under pressure. The successful candidate will provide CMC regulatory support for new marketing applications and post-approval regulatory filings across international regions, including Asia, Latin America, Middle East, Eastern Europe and Africa.

RESPONSIBILITIES

• Work with Pharmaceutical Development, Analytical, Manufacturing and QA teams to assist and support the preparation of the Quality sections of new marketing authorization applications, post‑approval variations, renewals and responses to agency questions, for submission in International markets.

• 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 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.

• Complete regulatory assessments for post-approval CMC changes and execute filing plans for assigned markets according to agreed priorities.

• Build and maintain a current awareness of CMC registration requirements across International regions.

KNOWLEDGE, EXPERIENCE AND SKILLS

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

• 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.

• Knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.

• 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.