Senior Manager, Regulatory Affairs
3 months ago
Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include liver diseases, infectious diseases, inflammatory diseases and cancer.
Gilead Sciences in Melbourne, Australia is seeking a knowledgeable and motivated professional capable of working effectively in a cross-functional team environment. The successful candidate will assume a 12-mth contract in the Regulatory Affairs department and report to the Senior Director, Regulatory Affairs. The position will remain open until a suitable candidate is found.
Specific Job Responsibilities:
Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for Australia and New Zealand in line with ICH requirements and scientific and company policies and procedures.
Responsible for submissions for marketing authorisation and variations. Other submissions such as safety reports, amendments, supplements, clinical trial applications as required, authorizations, original, marketing authorization applications for territories other than the US and EU and for contributing to preparation of US and EU marketing authorizations.
Provides local regulatory expertise for labelling changes and to submission teams on specified projects and topics.
Provides input to senior Regulatory Affairs professionals in the preparation of country specific labelling.
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses.
Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to complex programs/projects.
Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge.
Initiates or contribute to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.
Excellent organization skills and ability to work on a number of projects with tight timelines is required.
Excellent verbal and written communication skills and interpersonal skills are required.
Must have in-depth knowledge of Australian regulatory requirements, including ICH requirements and an understanding of global regulatory requirements. Is recognized as a knowledgeable resource within the department on a range of topics.
Specific Education & Experience Requirements:
8+ years of experience in Australian Regulatory Affairs
Must have extensive experience negotiating and interacting with the Therapeutic Goods Administration.
Must have the ability to perform as a senior member of a team with diverse membership from all functions and levels of the company.
Degree in a scientific field is preferred.
Gilead Core Values:
Integrity (always doing the right thing)
Teamwork (collaborating in good faith)
Excellence (working at a high level of commitment and capability)
Accountability (taking personal responsibility)
Inclusion (encouraging diversity)
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 for assistance.
For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ 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 jobs in France:
Conformément à la Loi « Informatique et Libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par Gilead et pourront être transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com
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