Description
FUNCTION: Global Therapeutic Area (TA) Regulatory Liaisons
POSITION OVERVIEW:
We are looking for a unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for a Senior Manager to join the Gilead Virology Team. The future of the role encompasses providing regulatory strategy, leadership, and support as the Regional Regulatory Lead on the assigned products, compounds, indications or projects. With guidance, defines the regulatory strategy, plans and objectives for the assigned products or projects. You will lead the Regulatory Submissions Teams associated with assigned products or projects and represent Global TA Regulatory to cross-functional sub-teams. May serve as a Gilead contact to / for regulatory authorities. Manage, oversee and coach less experienced colleagues. You will oversee and manage the work of less experienced colleagues supporting your work. You will coach and advise less experienced colleagues in completing their work and developing their regulatory capabilities. Typically assigned products, compounds, indications or projects of increasing complexity. May play a more active role in process improvements and other special projects that can carry significant value to multiple Regulatory Affairs activities and teams.
JOB RESPONSIBILITIES:
1. Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional teams ( e.g., Study Management, Clinical, Nonclinical, Biomarkers and/or cross-regional Regulatory Submission Teams.
2. With guidance, defines the regulatory strategy for one or more Gilead products or projects (development or marketed products).
3. Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans.
4. Leads the preparation, compilation, and timely filing of complex regulatory submissions, which require cross-functional interactions for commercial or investigational product(s) for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include meeting requests, briefing packages, initial clinical trial applications/Amendments or routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.) as well as post-approval submissions for marketed products.
5. Leads cross-functional teams in the authoring of regulatory documents and including meeting requests.
6. Responsible for ensuring regional product labelling is created and maintained in alignment with the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI).
7. Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets.
8. Critically reviews documents for submission to regulatory authorities.
9. Initiates or otherwise contributes to process improvements and/or other special projects within Regulatory Affairs.
10. Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
Education and/or Experience required
11. Life Science degree
12. Extensive experience Regulatory Affairs or other relevant industry experience
13. Experience setting the regulatory strategy and leading regulatory submissions and other activities for a medicinal product is strongly preferred.
14. 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.
15. Good knowledge of regulatory requirements for the EU centralised procedure. Experience in co-ordinating post-approval variations, renewals, responses to questions, PSURs etc. for EU centralised products is desirable.
16. Experience of regulatory requirements in other countries/regions is desirable.
17. Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials would be advantageous.
18. Experience in working with document management systems.
19. Experience successfully leading departmental and cross-functional teams without authority.
20. Experience authoring and implementing processes.
21. Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
Knowledge & Other Requirements
22. Excellent verbal and written communication skills and interpersonal skills are required.
23. Demonstrated ability to be a fast learner.
24. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
25. Demonstrates advanced knowledge of regulatory requirements and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives, including ICH standards and the regulatory requirements for assigned markets.
26. In-depth knowledge of relevant health authorities, including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
27. Able to represent Gilead to regulatory authorities when managing standard or more routine negotiations.
28. Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
29. Ability to lead and influence programs, projects and/or initiatives.
30. Strong interpersonal skills and understanding of team dynamics.
31. Proven ability to work successfully in a team-oriented, highly-matrixed environment.
32. When needed, ability to travel.
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.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.