Veeva is a mission-driven organization that aspires to help our customers in Life Sciences and Regulated industries bring their products to market, faster. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, and Speed. Our teams develop transformative cloud software, services, consulting, and data to make our customers more efficient and effective in everything they do. Veeva is a work anywhere company. You can work at home, at a customer site, or in an office on any given day. As a Public Benefit Corporation, you will also work for a company focused on making a positive impact on its customers, employees, and communities.
The Regulatory Liaison Officer (RLO) serves as the central point of contact for Veevas relationship with global health inspection authorities such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Medicines and Healthcare Products Regulatory Agency (MHRA). The RLO stays informed about intra-agency meetings, issues, pending regulations, and proposed regulatory guidance to assess what parts of the organization may be affected by new regulatory initiatives. The RLO will speak, educate, and promote technological developments and industry best practices (e.g., Cloud, IaC, Agile) related to agencies regulatory mandates for patient safety and data integrity.
What You'll Do
- Provide technical expertise, regulatory interpretation, and direction in regard to federal regulations regarding SaaS, Cloud Computing, Data Integrity, IT Compliance.
- Monitor and analyze regulatory developments and help determine what parts of the organization may be affected by new regulatory initiatives.
- Working closely with the organizations legal, government affairs, and strategy functions to establish a risk profile
- Proactively engage global health authorities to promote evolving technologies in support of Veevas business strategy.
- Form an active network of peers at other similar institutions and memberships in industry organizations to establish industry compliance frameworks based on best practices and technologies.
- Bachelors degree in Engineering/ Sciences or equivalent relevant technical experience. Advanced degree preferred.
- At least 7 years of executive experience in a regulatory liaison/affairs department.
- Established a strong network of internal and external contacts to gather intelligence regarding developing areas of interest on international regulatory agendas.
- Excellent written and oral communication skills, good decision-making skills, and time management skills.
Nice to Have
- Experience with cloud-based applications and/or infrastructure compliance
- Understanding of Agile development methodology
Veevas headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.