Manager, Regulatory Affairs CMC - Analytical Chemistry
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Manager, Regulatory Affairs CMC - Analytical Chemistry
With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Gilead Science has an exciting opportunity for a Manager, CMC Regulatory Sciences. This role will specifically be supporting Rest of World (ROW) regulatory filings. You will be responsible for scientific response and inquiries from regulatory agencies.
- Responsible for authoring analytical sections of regulatory CMC submissions in support of clinical and commercial applications
- Responsible for reviewing technically complex regulatory CMC submissions in support of clinical and commercial applications
- Ensure regulatory submissions are in line with ICH requirements, regional requirements and scientific and company policies and procedures
- Work closely with Analytical Operations and other CMC functional groups as well as Regulatory Affairs to plan and produce high quality regulatory submissions while meeting aggressive timelines
- Work closely with Analytical Operations and other CMC functional groups to author and review response to questions received from regulatory agencies
- Ensure that consistency is maintained across development projects, and that sound scientific justification is employed in CMC regulatory strategy
- Maintains up to date knowledge of regulatory requirements and communicates changes in regulatory information to project teams and senior management in a timely manner
- Excellent verbal and written communication skills and interpersonal skills are required.
- Ensure that analytical content of CMC dossiers meet Gilead and ICH format and content requirements
- Must be proactive in staying current with registration requirements in each of the applicable regions and must communicate this information to Analytical Operations teams and management.
- Will work with international colleagues to ensure consistency of responses to international Health Authorities.
- On a regular basis, participate in industry trade groups and regulatory professionals associations.
- Will be expected to use industry network to maintain an awareness of the pulse of CMC best practices, and to disseminate this information to the corporation.
- Form ad hoc task forces to address critical CMC issues on behalf of project and department teams
- Initiates local process improvements and contributes to local and/or global process improvements, which have a significant impact on the overall efficiency of the regulatory submission process
- May direct others in accomplishing corporate objectives
- Plans, schedules and arranges own activities and those of direct report (if applicable).
Knowledge & Skills
- Knowledge of regulatory requirements, including ICH requirements and regional requirements and have an in-depth understanding of current global and regional trends in technical regulatory affairs.
- Excellent verbal and written communication skills and interpersonal skills.
- Must be a team player and a self-starter with the ability to work with no immediate direction from a senior regulatory affairs professional.
Education & Experience
- A Bachelor's Degree and a minimum of seven (7) years of experience in Regulatory Affairs CMC or other relevant industry experience with OR a Master's Degree and a minimum of five (5) years of experience in Regulatory Affairs CMC or other relevant industry experience.
- Experience in authoring technical content of regulatory submissions and capable of leading a CMC subteam in preparation of submissions.
- Advanced degrees including PhD and MS with a focus on analytical chemistry or related field.
- Relevant industry experience.
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.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. 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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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.
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