Regulatory Affairs Manager

Regulatory Affairs Manager
Empresa:

Gilead Sciences, Inc.


Regulatory Affairs Manager

Detalles de la oferta

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**

**Regulatory Affairs Manager Mexico.**

**Essential Duties and Job Functions:**

+ Responsible for preparing regulatory submissions which require cross-function interactions with internal and external partners (as appropriate) for commercial products meeting local regulatory requirements and company policies and procedures.

+ Responsible for product registration submissions for assigned products, which may include new marketing applications, routine submissions (e.g., renewal) as well as post approval variations (CMC and labelling) as needed.

+ Provides regulatory support to review/approve local product labelling, packaging material texts/artworks in accordance with local requirements and in alignment with company policies and standards.

+ Reviews promotional material ensuring compliance with the registered details and local code of practice and prepares submissions to the Agency for approval/notification.

+ Proactively keeps abreast of new or changes in legislation, analyzing the impact to Gilead and communication thereof to the relevant stakeholders.

+ Initiates or contributes to local process improvement initiatives, which have an impact on the working of the Regulatory Affairs function or other departments.

+ Supports activities to control department budget.

+ Coordinates and reviews translations needed.

+ Oversees the local Quality Management System for the organization of documents and processes including the administrative work needed to keep regulatory records and databases on track.

**Knowledge, Experience and Skills**

+ Minimum of a BA/BS degree.

+ Minimum 5 years of relevant experience in the Pharmaceutical Industry within Regulatory Affairs.

+ Excellent organizational, communication and interpersonal skills.

+ Ability to work independently on multiple projects with tight timelines is required.

+ Good understanding of regulatory requirements, including ICH requirements and excellent knowledge on local regulatory requirements.

+ Able to work under minimal supervision

+ Team player

+ Strong communicator

+ Very good attention to detail

+ Fluent in English (written and verbal)

#LI-DNI

**For Current Gilead Employees and Contractors:**

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

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.
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 at *****


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