Global Regulatory Policy and Intelligence engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across the Company to advance important Regulatory policy issues aligned with Company's goals and priorities. It also manages Regulatory Intelligence for the Global Regulatory Affairs organization, enabling fast, efficient global filings by effectively monitoring, analyzing, and communicating regulatory requirements to regulatory strategy leads and others involved in the delivery of regulatory submissions and approvals.
location: Telecommute
job type: Contract
salary: $25.00 - 29.85 per hour
work hours: 9 to 5
education: High School
responsibilities:
The Sr. Associate Regulatory Intelligence role performs monitoring and analysis of the global regulatory landscape according to defined plans and priorities and delivers agreed regulatory intelligence outputs.
- Uses internal and external contacts, tools and systems to gather regulatory intelligence
- Applies professional skills and experience with advanced tools to summarize and contextualize regulatory intelligence information and identify trends in agency feedback
- Works with limited supervision according to predefined regulatory intelligence workplans
- Applies tools and systems to deliver agreed intelligence objectives
- Communicates progress and escalates issues impacting delivery of intelligence outputs
- RI Gathering, Monitoring & Surveillance. Identify and document key regulatory requirements for global submissions. Track updates from global regulatory authorities (e.g., FDA, EMA, MHRA, PMDA, TGA) and internal contacts. Monitor industry newsletters, journals, press releases, and competitor activity. Set alerts in regulatory intelligence platforms (e.g., Cortellis, IQVIA) for new guidance's, legislation, or enforcement trends.
- Database & Knowledge Management. Maintain a centralized regulatory intelligence repository (e.g., SharePoint, internal dashboards). Ensure historical tracking and tagging of relevant changes for future reference.
- Communication & Reporting. Draft and distribute regulatory intelligence newsletters or briefs. Prepare summaries or presentations on key changes. Update internal stakeholders (Regulatory Affairs, Quality, Clinical, R&D, etc.) on high-impact developments.
qualifications:
Required:
- Master's degree OR Bachelor's + 2 years experience OR Associate's + 4 years experience OR High school/GED + 6 years experience
- 2+ years industry experience post-college, Life Science background.
- Regulatory Knowledge & Analysis: Understands global frameworks (FDA, EMA, ICH), interprets complex texts.
- Research & Monitoring: Uses intelligence tools (Cortellis, IQVIA), monitors authorities/competitors, synthesizes data.
- Communication & Influence: Translates info into clear guidance, creates reports/alerts.
skills: FDA, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
