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Manager, Regulatory Affairs CMC
Manager, CMC Regulatory Sciences
The Manager of CMC Regulatory Sciences is responsible for authoring analytical related sections of clinical, marketing authorization applications, post-approval variations, renewals for submissions in local and international markets. The Manager also supports
CMC life-cycle management activities.
- Author and review analytical related sections of clinical, marketing authorization applications, post-approval variations, for submissions in local and international markets.
- Ensure regulatory submissions are in line with ICH guidance, local statutory requirements, scientific principles, and business policies and procedures.
- Ensure that consistency is maintained across development projects, and that sound scientific justification is employed in CMC regulatory strategy
- Work cross functionally to plan and produce high quality regulatory submissions while meeting aggressive timelines
- Maintains up to date knowledge of regulatory requirements and communicates changes in regulatory information to project teams and senior management in a timely manner
- Contribute to local and/or global process improvements
Knowledge and Skills:
- Excellent verbal and written communication skills and interpersonal skills
- Knowledge of regulatory requirements related to chemistry, manufacturing and control (CMC), including ICH requirements and regional requirements and have an understanding of current global and regional trends in technical regulatory affairs.
- Must be a team player and a self-starter with the ability to work independently.
- Must demonstrate the ability follow corporate procedures and instructions from senior management.
Education and Experience:
- A Bachelor’s Degree and a minimum of seven (7) years of experience in Regulatory Affairs CMC or other relevant industry experience OR an advanced degree and a minimum of five (5) years of experience in Regulatory Affairs CMC or other relevant industry experience.
- Advanced degrees including PhD and Masters with a focus on analytical chemistry, chemical engineering, pharmacy/pharmaceutical sciences, or related field is highly desirable
- Must be experienced in authoring technical content of regulatory submissions
- Experience in analytical method development/validation, good manufacturing practices/quality assurance, drug substance or product manufacturing in pharmaceutical industry is highly desirable.
Gilead Sciences, Inc. 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 therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our
growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Learn more here
Job posted: 2022-01-03