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Director, Regulatory Affairs – Advertising and Promotion

ComplianceComplianceFull TimeRemoteTeam 201-500Since 2015H1B No SponsorCompany Site LinkedIn

Location

California

Posted

30 days ago

Salary

$200K - $240K / year

Bachelor Degree12 yrs expEnglish

Job Description

• Review medical education and commercial advertising and promotional materials to ensure compliance with applicable regulatory requirements • Serve as a regulatory reviewer on the Medical, Legal, Regulatory (MLR) committee and/or Medical Review Committee (MRC) teams • Assist with 2253 submissions • Monitor competitor space advertising and promotion materials • Provide strategic input on campaigns for compliant product communications • Identify MLR/MRC process or system improvements • Articulate complex regulatory issues to project teams and external stakeholders • Implement strategies to ensure programs are within the framework of published guidance documents • Assist with managing budgets for functional area • Develop relationships with external parties (e.g., CROs, consultants) and stay current on industry trends

Job Requirements

Bachelor’s or M.S./Ph.D. degree in scientific area
Minimum of 12 years with a Bachelor’s, or 10 years with an MS/PhD of relevant Regulatory Affairs experience in a biotech / pharmaceutical setting
Minimum of 8 years supervisory experience
Thorough knowledge of FDA advertising and promotion regulations and guidance
Experience with MLR or promotional review committees supporting product communications and managing regulatory submissions of promotional materials
Experience and understanding of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA regulations
Excellent negotiation skills
Excellent written and oral communication skills
Strong organizational skills, including the ability to prioritize workload
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint)

Benefits

discretionary annual target bonus
stock options
ESPP
401k match
health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
winter company shutdown