Sr Manager, Biologics CMC Reg. Strategy

Senior Manager, 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.

Senior Manager, Biologics CMC Regulatory Strategy (Open for Remote Role)

Gilead Sciences in seeking a Senior Manager, Biologics CMC Regulatory Strategy candidate to support 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 regulatory affairs and 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.
  
• Under the direction of the Associate Director or Director, support regulatory CMC team and SMEs in evaluation of regulatory risks and developing phase-appropriate risk mitigation strategies.
  

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, chance control, regulatory assessments.
  
• Work cross-functionally by attending project team meetings as needed to support clinical development projects.
  
• Identify and implement improvements to work processes to optimize productivity, efficiency, and regulatory outcomes.
  

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 eight (8) 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 six (6) years of experience in Regulatory Affairs CMC or other relevant industry experience.
  
• One to three (1-3) years of relevant experience in drug substance process development, drug product development, or analytical development.
  
• One to three (1-3) years of CMC Regulatory Affairs or regulatory technical writing experience.
  

Preferred Experience

• An advanced degree in a scientific field, PhD and MS is desired.
  
• Relevant regulatory or 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.


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