Global Therapeutic Area
2 weeks ago
Apply locations United Kingdom - Cambridge, United Kingdom - Uxbridge
Time type: Full time
Posted on: Posted 9 Days Ago
Job requisition id: R0043604
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 cross-functional core and sub-teams.
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 cross-functionally 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, ranging from new product licenses to lifecycle activities and oversight of all regulatory aspects of the application.
- Responsible for the preparation of regulatory submissions for products in the virology therapeutic area and execution of agreed strategies within the region.
- Partner within regulatory affairs and throughout the development and commercial organization. Collaborate with cross-functional partners to ensure optimal execution 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 post-licensing 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 in 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, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's 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.
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