Manager, Regulatory Affairs
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Job Location:
Mexico City - Mexico
Monthly Salary:
Not Disclosed
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
Experience Requirements:10 years of experience in Regulatory Affairs or other relevant industry experience Degree in a scientific field is preferred.
Specific Job Responsibilities:
Responsible for coordinating regulatory submissions sent to the distributor countries and responsible to prepare submission under the Mexican requirements. Responsible for submissions which may include CMC variations labeling updates and renewals. Provides regulatory expertise to labeling changes and to submission teams on specified projects and input to senior Regulatory Affairs professionals in the preparation of country specific be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/ under guidance of immediate manager for own self-development and acquisition of required regulatory skills and or contribute to local process improvements which have an impact on the working of the Regulatory Affairs function or other organization skills and ability to work on a number of projects with tight timelines is verbal and written communication skills and interpersonal skills are have in-depth knowledge of regulatory requirements in Mexico and some knowledge for Colombia Argentina Chile and Uruguay. Work is performed under minimal direction of a senior Regulatory Affairs professional.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
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 ensu ... View more
