Small Molecules Regulatory Affairs CMC Senior Manager
Small Molecules Regulatory Affairs CMC Senior Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 157590 - 203940
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 lifechanging 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
Responsibilities
The Regulatory Affairs CMC Senior Manager at Gilead is responsible for providing strategic direction tactical support and technical expertise for CMC regulatory activities and related regulatory initiatives.
Responsible for guiding and overseeing the preparation of complex regulatory CMC submissions for investigational and commercial products with solid scientific foundations in compliance with ICH and regional requirements and in alignment with company policies and procedures.
Works collaboratively in cross functional matrix teams to develop a CMC submission plan in accordance with business objectives.
Actively collaborates with internal teams (including Technical Development and Manufacturing Supply Chain and Quality) to identify and rank risks proposes risk mitigation plans develops and executes robust CMC regulatory strategies.
Provides advice and drives decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
Provides regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises.
Collaborates with colleagues across the global RA CMC organization Gilead regulatory affairs and affiliates on internal meetings and Health Authority interactions.
Proves ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends.
Leads interactions with FDA and other Health Authorities for CMCrelated topics (including management of regulatory deliverables and commitments).
Basic Qualifications:
BA in relevant scientific discipline and 8 years of experience OR
MS in relevant scientific discipline and 6 years of experience OR
PhD/PharmD in relevant scientific discipline and 2 years of experience OR
MD
Preferred Qualifications
Has 5 years of relevant experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree. Experience in scientific/technical field is preferred.
A bachelors degree in a relevant scientific discipline. An advanced degree is preferred.
A proven track record of developing global CMC regulatory submissions strategies in all phases of drug development including life cycle management.
Collaborative proactive and highly organized approach to work.
Demonstrated track record with strategic planning problem solving and working within a global matrix team environment successfully managing CMC regulatory activities and initiatives.
Deep understanding of global regulatory requirements and guidelines.
Excellent communication and interpersonal skills.
For additional benefits information visit:
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Senior Manager
Employment Type
Full-Time
