USA-Project Manager III (Professional)

Mindlance; Cambridge (MA); Remote; USD 80 000 - 110 000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs professional to lead compliance efforts in promotional and advertising materials. This role involves collaborating with commercial teams from concept to approval, ensuring adherence to federal regulations and corporate policies. The ideal candidate will have over six years of experience in regulatory affairs, possess strong leadership skills, and be adept at training personnel on compliance matters. This is a fantastic opportunity to make a significant impact in a dynamic environment while working with a diverse and inclusive team.

Qualifications

• 6+ years of experience in regulatory affairs.
• Proven ability to collaborate with cross-functional teams.

Responsibilities

• Provide regulatory guidance on promotional materials.
• Collaborate with legal teams to ensure compliance.
• Train sales and marketing personnel on regulations.

Skills

Regulatory Leadership

Compliance Knowledge

Advertising Regulations

Collaboration

Training Skills

Education

Bachelor's Degree

Job description

Job Description

MAX BILL RATE: ***/hr***
Can be remote!

External Title: Promotional & Advertising Regulatory Affairs, Promotional Compliance - US Regulatory Affairs

Provide regulatory leadership and guidance to Commercial teams during the development, review, and approval of product labeling and advertising materials.

Work directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB submission.

Provide a leadership role on the review committee (RC) by offering regulatory guidance on promotional labeling and advertising materials.

Collaborate with Compliance and Legal teams to ensure materials approved by RC are used within the intended guidelines.

Review content and format of documents to ensure compliance with corporate policies, federal regulations, guidelines, and product development objectives.

Work collaboratively with medical and scientific personnel on the development and review of advertising and promotional materials.

Participate in training sales and marketing personnel on promotional, labeling, and advertising regulations.

Serve as FDA liaison for matters related to the advertising and promotion of assigned products.

Minimum Education: Bachelor's Degree

Years of Experience: 6+ years

About the company

Mindlance is one of the largest diversity-owned staffing firms in the US. As a recruitment-centric talent acquisition company, Mindlance provides Technology, Engineering, Digital / Creative / Marketing, Clinical Research, Scientific, Finance, Professional, and Payroll Management staffing services to Global 1000 companies across the US, Canada, and India.