Director, Biologics CMC Regulatory Strategy

Company: Professional Diversity Network - Client
Location: Oceanside
Posted on: October 16, 2020

Job Description:

Director, Biologics CMC Regulatory Strategy 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. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Gilead Sciences in seeking a Director, Biologics CMC Regulatory Strategy candidate for our Oceanside, CA Biologics Development and Manufacturing facility. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible. 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) to draft CMC sections of clinical trial and marketing authorization applications and supplements (e.g. IND, IMPD, CTA and marketing applications BLA, MAA, JNDA, CNDA) by providing phase-appropriate templates and monitoring the availability of source documents. Review drafted CMC sections in collaboration with various contributors and stakeholders for the appropriateness and accuracy of technical content. Identify key regulatory issues with potential cross-project impact and raise awareness with and appropriately influence affected teams. Support the maintenance of control strategies throughout a program's life-cycle. Provide training to project teams on good writing practices for regulatory and project documentation. Must work well under deadlines and have excellent attention to detail. Strong organizational skills required. Relevant experience is required in executing biologics CMC strategy for submissions to health authorities in the US, EU and other regions. This position will report to VP, Biologics Process Development and will be responsible for establishing CMC content strategy for each submission of development and commercial phase biologics. Responsible for the preparation of CMC sections through interaction with SMEs who draft the sections. 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: PAI, maintenance of local manufacturing license, et cetera. Maintain knowledge of CMC regulatory requirements up-to-date and communicates changes in regulatory information to project teams and senior management in a timely manner. Work cross-functionally by attending project teams appropriately for supported clinical development projects. Plan, schedule, and arrange own activities and may direct others in accomplishing objectives. May identify and implement improvements to group processes to optimize productivity and regulatory outcomes. Mentor junior members of the team. Contribute to finalizing a variety of regulatory submissions which may include clinical trial and marketing authorization applications and supplements and responses to agency questions. Knowledge & Skills Excellent organizational skills and ability to simultaneously work on multiple projects with defined timeline. Excellent verbal and written communication skills and interpersonal 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. Education & Experience A Bachelor of Science degree with a minimum of twelve (12) 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 ten (10) years of experience in Regulatory Affairs CMC or other relevant industry experience. A minimum of three (3) years of relevant experience in biologics process 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. People management 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.avature.net/Gilead 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 ACTYOUR 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

Keywords: Professional Diversity Network - Client, Oceanside , Director, Biologics CMC Regulatory Strategy, Executive , Oceanside, California