Senior Manager, Regulatory Affairs (12mth FTC) 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) About Us Gilead Sciences, Inc.
is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.
Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
#J-18808-Ljbffr
