Gilead Sciences, Inc.
Sr. Regulatory Affairs Associate, CMC
Gilead Sciences, Inc., Foster City, California, United States, 94420
Sr. Regulatory Affairs Associate, CMC
Location:
United States - California - Foster City
Time Type:
Full time
Posted on:
Vor mehr als 30 Tagen ausgeschrieben
Job Requisition ID:
R0042795
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s 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 we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
Job Description
Responsibilities:
Develop and manage content strategy for global regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision.
Represent Regulatory Affairs (RA) CMC on product development and life-cycle management teams to identify critical issues, negotiate, influence, and provide strategic advice to peers in Pharmaceutical Development and Manufacturing, RA, and Regulatory Operations.
Develop strategies for CMC meetings, manage preparation for agency meetings and manage content of pre-meeting submissions with little RA CMC management support.
Analyze and interpret technical information that impacts regulatory decisions and strategies. Seek expert advice and technical support as required, analyze and interpret information provided to facilitate informed regulatory decisions for submissions.
Author high quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends, and guidelines.
Manage products and change controls with a robust understanding of regulations, company policies, and procedures.
Stay current on global regulatory procedures, requirements, and changes in the regulatory landscape. Analyze evolving legislation, regulatory guidance and provide analysis to the project teams.
Develop, implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager. Participate in initiatives internal to CMC RA.
Knowledge, Experience, and Skills: Basic Qualifications:
Master's Degree with 3+ years of industry experience in CMC regulatory affairs; or Bachelor's Degree with 5+ years of pharmaceutical CMC regulatory related experience.
Degree in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related subject.
Preferred Qualifications:
Advanced degree desired.
Experience working in a complex and matrix environment.
Strong verbal and written communication skills.
Collaborative, proactive, and highly organized approach to work.
The salary range for this position is: $124,015.00 - $160,490.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package which includes company-sponsored medical, dental, vision, and life insurance plans.
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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.
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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United States - California - Foster City
Time Type:
Full time
Posted on:
Vor mehr als 30 Tagen ausgeschrieben
Job Requisition ID:
R0042795
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s 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 we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
Job Description
Responsibilities:
Develop and manage content strategy for global regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision.
Represent Regulatory Affairs (RA) CMC on product development and life-cycle management teams to identify critical issues, negotiate, influence, and provide strategic advice to peers in Pharmaceutical Development and Manufacturing, RA, and Regulatory Operations.
Develop strategies for CMC meetings, manage preparation for agency meetings and manage content of pre-meeting submissions with little RA CMC management support.
Analyze and interpret technical information that impacts regulatory decisions and strategies. Seek expert advice and technical support as required, analyze and interpret information provided to facilitate informed regulatory decisions for submissions.
Author high quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends, and guidelines.
Manage products and change controls with a robust understanding of regulations, company policies, and procedures.
Stay current on global regulatory procedures, requirements, and changes in the regulatory landscape. Analyze evolving legislation, regulatory guidance and provide analysis to the project teams.
Develop, implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager. Participate in initiatives internal to CMC RA.
Knowledge, Experience, and Skills: Basic Qualifications:
Master's Degree with 3+ years of industry experience in CMC regulatory affairs; or Bachelor's Degree with 5+ years of pharmaceutical CMC regulatory related experience.
Degree in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related subject.
Preferred Qualifications:
Advanced degree desired.
Experience working in a complex and matrix environment.
Strong verbal and written communication skills.
Collaborative, proactive, and highly organized approach to work.
The salary range for this position is: $124,015.00 - $160,490.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package which includes company-sponsored medical, dental, vision, and life insurance plans.
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
#J-18808-Ljbffr