Regulatory Specialist

ComplianceComplianceFull TimeRemoteTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

27 days ago

Salary

$110K - $138K / year

Bachelor Degree4 yrs expEnglish

Job Description

• Coordinate the end-to-end preparation, review, and timely filing of postmarket reporting submissions. • Coordinate with cross-functional teams (i.e., Marketing, Brand, Commercial, Regulatory Science, Legal, etc.) to organize all applicable aspects of postmarket reporting submission materials and ensure compliance with U.S. federal regulatory obligations. • Manage complex regulatory timelines, ensuring all stakeholders meet milestones for recurring federal filings. • Assess and identify potential regulatory risks related to advertising, promotion, labeling, and operations and work with Regulatory Leadership to mitigate potential risks. • Maintain up-to-date knowledge of evolving regulatory requirements and sales and distribution restrictions applicable to tobacco product marketing and advertising in the U.S. • Perform related duties as assigned, within your scope of practice.

Job Requirements

  • Experience in US Regulatory Affairs, preferably with tobacco, nicotine-containing products, pharmaceuticals, or other regulated industries. Experience with coordination and execution or review of regulatory compliance reporting and/or related submissions preferred.
  • Working knowledge of FDA and FTC regulations and industry best practices and standards for promotional review and compliance. Experience in regulatory marketing compliance preferred.
  • Familiarity with global marketing requirements for tobacco, nicotine-containing products.
  • Demonstrated ability to work independently and with cross-functional teams.
  • Strong written and verbal communication skills.
  • High level of attention to detail, well-organized, and strong analytical and critical thinking skills.
  • Ability to thrive in a fast-paced, matrixed environment and adapt to evolving business and regulatory landscapes.

Benefits

  • A place to grow your career. We’ll help you set big goals - and exceed them
  • People. Work with talented, committed and supportive teammates
  • Equity and performance bonuses. Every employee is a stakeholder in our success
  • Cell phone subsidy, commuter benefits and discounts on JUUL products
  • Excellent medical, dental and vision, disability, and life insurance, plus family support, wellness, legal, and employee assistance program benefits
  • 401(k) plan with company matching
  • Plus biannual discretionary performance bonuses

Related Categories

Related Job Pages

More Compliance Jobs

Full TimeRemoteTeam 201-500H1B No Sponsor

Compliance Analyst ensuring audit readiness for fintech startup Tilt

SQL
United States
$76.8K - $90.4K / year
Full TimeRemoteTeam 22,291Since 1980

The Trade Compliance Auditor audits customs-related compliance in the U.S., Canada, and EMEA, creating procedures, plans, and monitoring trade operations for adherence to laws.

Thomson Reuters OnesourceTrade Compliance Software
Michigan + 2 moreAll locations: Michigan, California, Connecticut
$76.5K - $112.2K / year
Full TimeRemoteTeam 11-50H1B No Sponsor

Director of Regulatory Affairs responsible for compliance with regulatory requirements in global clinical trials

Massachusetts

Compliance Analyst

CyberSheath

Assess, Implement, Manage (AIM™)

Compliance27 days ago
Full TimeRemoteTeam 51-200Since 2012H1B No Sponsor

Compliance Analyst overseeing cybersecurity compliance for DIB clients

Cyber Security
United States
$110K - $130K / year