Associate Director, Regulatory Affairs - Oncology

Descrizione del lavoro

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Specific Education & Experience Requirements:

• BS/BA degree with 10+ years of experience or MS/MA degree with 8+ years of experience or PhD/PharmD with 5+ years of experience.

• 10+ years of experience in Regulatory Affairs or other relevant industry experience.

• Degree in a scientific field is preferred.

Specific Job Responsibilities:

• Responsible for preparing and/or overseeing the preparation of technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.

• May direct others in accomplishing Corporate Objectives.

• Responsible for submitting complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories.

• Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products.

• Contributes to the regulatory review of draft Product Company Core Safety Information (CCSI) and ensures updates to the CCDS or CCSI are implemented.

• Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license.

• Provides strategic regulatory advice as appropriate.

• Maintains knowledge of regulatory requirements up to date and communicate changes in regulatory information to project teams and senior management in a timely manner.

• Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs Department or other departments.

• Plans, schedules and arranges own activities and those of direct reports (if applicable).

• Excellent verbal and written communication skills and interpersonal skills are required. Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs.

• Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.

• May be required to assume a leadership role in updating and preparing the Company for minor changes in legislation in assigned territories and of actively participating in a broader cross functional team for implementation of major changes. Must be capable of leading a small team in preparation of submissions and maintenance of licenses.

• Work is performed with no immediate direction from a senior Regulatory Affairs professional.

• Is recognized as a knowledgeable resource for Regulatory Advice in other departments.

• Demonstrated ability to act as primary Company contact with Regulatory Authorities. Previous people management experience is desirable.

• Direct experience working with Regulatory Authorities in assigned territories is required.

• Experience representing Regulatory Affairs on submission teams is mandatory and on Project Teams is desirable.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.