Job Title: Sr Regulatory Associate – 100% Remote
Duration: 12 months (Possible Extension)
Fully remote- PST working hours are preferable
 
Description:

• 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 the 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.
• 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.

 
Ideal candidate:
Job seeker who has couple of years industry experience outside of college with life science background
Regulatory Knowledge & Analytical Thinking.

• Strong understanding of global regulatory frameworks (FDA, EMA, ICH, etc.). Ability to interpret complex regulatory texts, guidance documents, and policy updates.

Research & Monitoring Proficiency.

• Experience in using regulatory intelligence tools and databases (e.g., Cortellis, Informa, IQVIA). Continuous scanning of health authority websites, publications, and competitor activity. Ability to synthesize large volumes of information into concise, actionable insights.

Communication & Strategic Influence.

• Strong written and verbal communication skills to translate regulatory developments into clear guidance. Ability to create reports, and alerts for cross-functional teams.

 
Day to Day Responsibilities:
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.

 
Red Flags:

• Lack of Regulatory Framework Knowledge.
• Doesn’t demonstrate familiarity with key regulatory bodies (FDA, EMA, ICH, etc.).
• Unable to interpret or explain the impact of a recent regulatory change or guidance.

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $26.00/hr.