Freelance Regulatory Submissions Specialist (Pharma Marketing)

Salary: 40-50 per hour

Victory Healthcare Communications is seeking a highly skilled and detail-oriented Freelance Regulatory Submissions Specialist (pharma marketing) to join our agency team on a freelance contract basis (with a possibility of full-time). As a Submission Specialist, you will be responsible for managing the submission process for pharmaceutical products, ensuring compliance with regulatory requirements and timely submissions to health authorities from MLR reviews and for public release or submission to regulatory bodies like the FDA. If you excel in ensuring content quality and handling submissions with precision, we want to hear from you!

About Victory Healthcare Communications:

At Victory Healthcare Communications, we specialize in delivering cutting-edge marketing strategies tailored for the pharmaceutical and healthcare industries. We combine creativity, strategic insight, and deep industry expertise to help our clients navigate the complexities of healthcare marketing and achieve success.The Victory team is a robust and dynamic group of professionals who love working together totransform bold ideas into extraordinary realities. With over 35 years of adventurous exploration in the pharmaceutical industry, Victory Healthcare Communications has notably turned complex information into compelling stories for more than 25 major pharmaceutical clients, including eight of the world's largest.

Essential Responsibilities:

• Collaborate with cross-functional teams, including Regulatory Affairs, Clinical Operations, Quality Assurance, and Medical Writing to gather necessary documentation for submissions.
• Ensure all submitted documents meet regulatory standards and guidelines (AMA 11 style and brand standards).
• Prepare submission packages according to specific health authority requirements.
• Conduct quality checks on submission documents for accuracy and completeness.
• Maintain up-to-date knowledge of relevant regulations and guidelines related to drug submissions.
• Keep track of submission timelines and ensure timely delivery of submissions.
• Assist in resolving any issues or queries related to submissions from health authorities.
• Prepare files for submission into Veeva Vault PromoMats or similar platforms.
• Incorporate feedback from Medical, Legal, and Regulatory (MLR) reviews with speed and accuracy.
• Annotating and fact-checking materials, ensuring claims are supported by cited sources.

Experience & Skills:

• At least 13 years proven experience as a Submissions Specialist within the pharmaceutical/pharma marketing industry.
• Knowledge of FDA regulations pertaining to drug development and submissions is essential.
• In-depth knowledge of MLR review processes using platforms like Veeva PromoMats with a clear understanding of compliance standards (ISI, fair balance, FDA promo review, etc.).
• Strong attention to detail with excellent organizational skills.
• Ability to work effectively in cross-functional teams under tight deadlines
• Proofreading experience is a plus!

Technical & Computer Skills:

• Proficiency with Veeva CRM and PromoMats.
• Expertise working in an Apple/Macintosh computer environment, as well as Apple software.
• Expertise working in Adobe Acrobat
• Expertise working in Veeva PromoMats
• Knowledge of Microsoft Office Suite (Excel, PowerPoint, Word, Sharepoint, Teams, Copilot).
• Knowledge of Google Workspace (Calendar, Sheets, Slides, Docs, Meet, and Gmail).
• Experience with Monday.com project management tools is a plus.

Why Join Victory?

We take pride in our collaborative culture, client dedication, and commitment to delivering work that improves patient access and understanding. If youre looking to work on meaningful projects with smart, passionate peoplewed love to connect.

Ready to Apply?

Apply with your resume. Applicants may be asked to complete a skills assessment as part of the interview process.

Victory Healthcare Communications is committed to hiring and developing exceptional talent to perform the many tasks necessary to providing high-quality service. An integral part of this policy is to provide equal employment opportunity for all persons considered for employment and to recruit and administer hiring, working conditions, benefits and privileges of employment, compensation, training, opportunities for advancement (including upgrading and promotion), transfer, and termination of employment (including layoffs and recalls) for all employees without discrimination because of race, creed, color, national origin, nationality, ancestry, age, sex (including pregnancy), familial status, marital/civil union status, religion, domestic partnership status, affectional or sexual orientation, gender identity and expression, atypical hereditary cellular or blood trait, genetic information, liability for military status, mental or physical disability (including perceived disability and AIDS and HIV status), or other characteristics unrelated to a persons qualification and/or job performance). If you are truly detail oriented, you will discover that you need to mention the word "spaceship" in one of the application questions.