Job Description

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



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.

Specific Responsibilities

* 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

Essential Functions

* 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 Bachelors Degree and a minimum of seven (7) years of experience in Regulatory Affairs CMC or other relevant industry experience with OR a Masters 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.

Preferred Experience

* Advanced degrees including PhD and MS with a focus on analytical chemistry or related field.
* Relevant industry experience.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead

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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.


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For Current Gilead Employees and Contractors:

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