Small Molecules Regulatory Affairs CMC, Senior Manager

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 157,000 - 204,000; Full time

Job summary

Join a forward-thinking company dedicated to tackling the world's biggest health challenges. As a Senior Manager in Regulatory Affairs CMC, you will play a pivotal role in shaping regulatory strategies for innovative therapies. This position offers you the chance to lead cross-functional teams, ensuring compliance with global regulations while driving impactful decisions. Your expertise will guide the preparation of critical submissions, fostering collaboration across diverse teams. If you are passionate about making a difference in healthcare and thrive in a dynamic environment, this role is your opportunity to contribute to groundbreaking advancements.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Medical insurance

Dental insurance

Vision insurance

Life insurance

Qualifications

• 8+ years of experience in Regulatory Affairs CMC or relevant industry.
• Proven track record of developing global CMC regulatory submission strategies.

Responsibilities

• Provide strategic direction for CMC regulatory activities.
• Guide preparation of complex regulatory submissions and collaborate with teams.

Skills

Regulatory Affairs CMC

Strategic Planning

Problem Solving

Communication Skills

Interpersonal Skills

Education

Bachelor in relevant scientific discipline

Master in relevant scientific discipline

PhD/PharmD in relevant scientific discipline

MD

Job description

Small Molecules Regulatory Affairs CMC, Senior Manager page is loaded

Small Molecules Regulatory Affairs CMC, Senior Manager

Bewerben locations United States - California - Foster City time type Full time posted on Vor 19 Tagen ausgeschrieben job requisition id R0044936

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.

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 CMC-related 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 bachelor’s 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.

The salary range for this position is: $157,590.00 - $203,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 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. 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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know 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.

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