Senior Director, Global Regulatory Strategy Leader - Oncology Programs
United States - New Jersey - Morris PlainsUnited States - California - Foster City
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
The Regulatory Affairs organization at Gilead has an exciting and highly impactful opportunity available for a Senior Director to build the Oncology portfolio at Gilead. This strategic leader will report into the VP of Regulatory Affairs and will guide and develop a team of regulatory strategists that are shaping the early and growing phases of Oncology at Gilead.Key Responsibilities:
- Responsible for development, oversight and communication of global regulatory strategy for assigned projects
- Serves as a Core member of the cross-functional Project Team representing the global regulatory strategy for assigned global multi-indication projects
- Leads Regulatory Project Team for assigned projects
- Leads or manages leads of cross-functional/cross-regional Regulatory Submission Teams and participates on other sub teams. Oversees submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
- Accountable for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures
- Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation and regulatory guidance is met for assigned product(s) and territories
- Accountable for preparation and maintenance of country specific labeling and product packaging (region specific) and ensuring alignment with relevant global Regulatory strategy
- Ensures up-to-date knowledge of highly complex regulatory requirements, contributes to preparation of new regulatory guidance, comments on draft regulatory guidance, and communicates changes in regulatory information to project teams and senior management
- Initiates or contributes to process improvements which have a significant impact on the business. Leader in Regulatory Affairs department leadership initiatives.
- People manager for regulatory liaisons involved in development and workload management
- Science degree (PhD, PharmD, MD, MSc) with 12+ years; Bachelors Degree with 14+ years of progressively responsible Regulatory Affairs experience within pharma/biotech industry to include Market Applications Submission experience (BLA/NDA/MAA) and experience developing and implementing regulatory strategy and managing complex negotiations with Regulatory Authorities
- Demonstrated effective verbal, written, negotiation and interpersonal communication skills are required
- Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business
- Proven track record with taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments
- Prior experience leading one or more teams in preparation of submissions and maintenance of licenses
- Recognized as an expert resource for Regulatory Advice in other departments
- Oncology filing experience including original BLA/NDA
- Global filing experience
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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 firstname.lastname@example.org for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
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