Pharma Regulatory Review Specialist

A specialized staffing and talent solutions company that helps professionals find top jobs with the nation’s leading brands. We’re looking to hire for our client, a leading global biopharmaceutical company. This is a 12+ month hybrid opportunity.

In this role, you’ll join the Regulatory Material Team to support FDA Ad Promo Submissions, Quality Control, and Regulatory Reviews. You’ll collaborate cross-functionally to ensure accurate and compliant promotional and non-promotional material approvals, while helping to drive process efficiency and compliance through Veeva systems management and reporting.

Pharma Regulatory Review Specialist Responsibilities:

• Coordinate promotional and non-promotional materials review and approval processes.
• Maintain in-depth knowledge of approval process routing grids and route the materials for approvals accordingly.
• Perform Quality Check review on the materials prior to routing.
• Collaborate with Sponsors and Agencies to develop and plan PRC Meeting Agendas.
• Collaborate with Marketing Operations on prioritization for routine approvals and complete the Regulatory Review of promotional and non-promotional materials, final reviews, and reapprovals.
• Manage user profiles, training needs, and access for Sponsors, Agencies, and Reviewers.
• Serve as a point of contact to the Veeva Vendor for ongoing maintenance and optimization of Veeva workflows.
• Generate Veeva metric reports to help with process improvement, resource management, and compliance monitoring.
• Prepare materials, Form 2253, and Cover Letters, and send them to Regulatory Operations for publishing and OPDP submission.

Pharma Regulatory Review Specialist Qualifications:

• Bachelor’s Degree in a Technical, Regulatory, or Science-related discipline.
• Good organizational and time management skills.
• Strong oral and written communication skills.
• Proficient with computer systems and/or pharmaceutical software, including Veeva.
• Experience in the pharmaceutical industry preferred; experience in prescription drug advertising/promotional labeling and/or promotional labeling submissions desired.
• Science background is a plus.

Perks & Benefits:

• Medical, Dental, and Vision Insurance.
• Life Insurance.
• 401(k) Program.
• Commuter Benefit.
• eLearning & Ongoing Training.
• Education Reimbursement.

Eligibility requires working over 30 hours per week on an assignment lasting at least 10 weeks.

If you meet the qualifications and are excited about this opportunity, apply today! Our team will connect with you to discuss next steps, support you through the interview process, and advocate for your success.

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About Onward Search

Onward Search is a nationwide staffing agency and talent solutions provider specializing in creative, marketing, and technology professionals. We work with our nationwide clients to continuously pipeline and fill specialized roles. As such, not all jobs contain an application deadline.

Equal Opportunity Employment

We are an equal opportunity employer. We do not discriminate based on race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other protected category. Candidates must be at least 18 years old to be considered for employment.

EOE/M/F/D/V/SO

Inclusive Hiring Practices

We’re committed to making every part of our hiring process accessible and inclusive. If you need any accommodations or adjustments to support you during the application or interview process, please contact us at inclusivehiring@onwardsearch.com.

Employment Eligibility

In compliance with federal law, all persons hired must verify their identity and eligibility to work in the United States. We are unable to support 1099 / Corp-to-Corp / Independent Contractor arrangements. All freelancers will be hired as W2 employees.

Benefits

We offer medical, dental, and vision insurance as well as a 401(k) retirement plan to all eligible full-time temporary employees. Onward Search is a drug-free workplace.

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Virtual Interview Process

To help streamline the hiring process and ensure a more flexible and accessible experience for all candidates, we’ve partnered with Apriora, a virtual interviewing platform. For select job openings, you may receive an invitation to interview with Alex, our virtual interviewer, via email at alex@onwardsearch.com.

Alex will guide you through a brief set of questions to help us better understand your background and interests. The virtual interview can be completed on your own time, and your responses will be reviewed by our recruiting team as part of the screening process.

To learn more about the platform, visit Apriora’s website.

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Job Seeker Scam Alert

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