Global Therapeutic Area TA Regulatory Liaisons - Manager
Global Therapeutic Area TA Regulatory Liaisons - Manager
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Job Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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
POSITION OVERVIEW:
The position is within the Virology IC/GPS (Intercontinental and Global Patient Solutions) Franchise working across territories throughout Asia Latin America Africa Eastern Europe and the Middle East.
You will work within the global team and closely with local teams to define the regulatory strategy plans and objectives for assigned products or projects. You will manage regulatory submissions and other projects representing the IC/GPS regulatory franchise on crossfunctional core and subteams.
You will act as the Regional Regulatory Lead on products in the virology therapeutic area covering HIV Hepatitis and Emerging Viruses projects/products.
You will typically be assigned multiple products or projects to lead manage and oversee simultaneously.
You will provide strategic and technical advice from development throughout the whole product lifecycle.
You will prepare and maintain regulatory submissions regulatory labelling and packaging for assigned products or projects; guide and advise other colleagues in the thorough and compliant completion of these activities.
You will work crossfunctionally with a diverse number of stakeholders both internally and externally to Gilead.
EXAMPLE RESPONSIBILITIES:
Responsible for managing and leading regulatory strategies for designated products in the region. This ranges from new product licenses to lifecycle activities and includes oversight of all regulatory aspects of the application.
Responsible for the preparation of regulatory submissions for products in the virology therapeutic area and of agreed strategies within the region.
Partner both within regulatory affairs and throughout the development and commercial organization. Collaborate with crossfunctional partners to ensure optimal of the agreed regulatory strategy.
Establish strong relationships with Gilead affiliates and distributor partners and serve as point person for knowledge for their product to these key stakeholders.
Have a good understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence.
Responsible for the preparation and maintenance of labelling to support MAAs and other postlicensing activities. Ensure that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
Liaise with regulatory manufacturing and other parties as appropriate to ensure that updates to the product packaging components are implemented in line with approved labelling in line with agreed timelines.
Participate and contribute to regulatory team meetings and be recognized as a knowledgeable resource for Regulatory Affairs in other departments.
May participate and lead collaborative efforts across function in process improvement initiatives.
Use internal electronic systems for planning preparing tracking and storing submissions to regulatory agencies.
REQUIREMENTS:
We are all different yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
BA/ BS or advanced degree in life sciences or related field with regulatory experience in the biopharma industry regulatory agency clinical research or other related healthcare environment. Experience a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.
Knowledge & Other Requirements
A good working regulatory knowledge including ICH and regional requirements.
An appreciation of current global and regional trends in Regulatory Affairs with proven effectiveness in applying this knowledge to optimize team deliverables.
Previous experience of working with emerging markets and/or in the Virology therapeutic area would be an advantage but not essential.
Methodical attention to detail.
Must have a can do attitude and be hands on as and when required.
Proven track record to manage formulate and execute strategy.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong negotiation and conflict resolution skills.
LOCATION
You can be based at Stockley Park or Cambridge office
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs companysponsored training education assistance social and recreational programs are administered on a nondiscriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Required Experience:
Exec
Employment Type
Full-Time
