Associate Director, Biologics CMC Regulatory Strategy

Location
Foster City
Salary
See job description.
Posted
August 10 2021
Ref
R0019664
Discipline
Life Sciences, Biology
Position Type
Full Time
Organization Type
Pharma


Associate Director, Biologics CMC Regulatory Strategy
United States Remote

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Associate Director, Biologics CMC Regulatory Strategy

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.

Gilead Sciences in seeking an Associate Director, Biologics CMC Regulatory Strategy candidate for our Oceanside, CA Biologics Development and Manufacturing facility.
  • Collaborate with biologics process development and analytical operations teams to ensure the use of efficient experimental approaches to facilitate establishment, alignment, and maintenance of biologics drug substance and drug product control strategies to meet current and upcoming regulatory requirements.
  • Support subject matter experts (SMEs) in drafting of Module 3 (CMC) sections of clinical trial and marketing authorization applications and supplements (e.g. IND, IMPD, CTA, BLA, MAA, JNDA, CNDA).
  • Collaborate with SMEs and contract manufacturing organizations (CMOs) to identify, track, archive, and monitor the availability of source documents supporting regulatory applications.
  • Review draft CMC sections in collaboration with contributors and internal and external stakeholders for the appropriateness and accuracy of technical content.
  • Working with regulatory CMC team and SMEs, identify and assess potential regulatory risks and influence teams to formulate phase-appropriate mitigation strategies.
  • Support the maintenance of integrated control strategies throughout a program's life cycle.
  • Relevant experience is required in executing biologics CMC regulatory strategy for submissions to health authorities in the US, EU and other regions.


This position will report to the Director of Biologics CMC Regulatory Strategy and will be a key contributor in establishing CMC content strategy for each major submission inclusive of development and commercial phase biologics.

  • Collaborate with SMEs to author, review, and finalized CMC sections for regulatory submissions.
  • Work closely with Regulatory Affairs team to ensure alignment of objectives of submissions and global submission timelines.
  • Provide support for cGMP activities as they relate to regulatory affairs submissions: PAI, change control, regulatory assessments.
  • Work cross-functionally by attending project teams meetings as needed to support clinical development projects.
  • Identify and implement improvements to work processes to optimize productivity, efficiency, and regulatory outcomes.
  • Contribute to finalizing a variety of regulatory submissions which include clinical trial and marketing authorization applications and supplements and responses to agency questions.


Knowledge & Skills:

  • Knowledgeable of regulatory requirements for biologics, including ICH requirements and US regional requirements.
  • Able to interpret regulatory requirements and collaborate with biologics development and/or commercial teams to create actionable plans to meet these requirements is required.
  • Excellent organizational skills and ability to simultaneously work on multiple projects with defined timeline is required.
  • Must work well under deadlines and have excellent attention to detail.
  • Excellent verbal and written communication skills and interpersonal skills are required.


Education & Experience:

  • A Bachelor of Science degree in a related field with a minimum of ten (10) years of experience in Regulatory Affairs CMC or other relevant industry experience, OR a Master's Degree or other advanced degree and a minimum of eight (8) years of experience in Regulatory Affairs CMC or other relevant industry experience.
  • A minimum of three (3) years of relevant experience in biologics drug substance process development, drug product development, or analytical development.
  • A minimum of three (3) years of CMC Regulatory Affairs or regulatory technical writing.


Preferred Experience

  • An advanced degree in a scientific field.
  • Advanced degrees, including PhD and MS, desired.
  • Relevant industry experience.


Gilead Core Values
  • Integrity (Doing What's Right)
  • Inclusion (Encouraging Diversity)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)


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: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg

About Gilead

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


For jobs in the United States:

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. 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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' 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 log onto your Internal Career Site to apply for this job.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States--Remote/Associate-Director--Biologics-CMC-Regulatory-Strategy_R0019664





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