Regulatory Specialist

REGULATORY SPECIALIST

At Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.

We believe that the combination of different ideas, experience, backgrounds, and skillsets create a great place to work. We pride ourselves on an authentic culture built around our core values of integrity, innovation, sustainability, growth, and accountability. We are committed to promoting an inclusive, equitable and diverse culture. Our global DE&I committee and our leadership team have committed to increasing representation, education, and accountability across the entire business to create positive change from the ground up and the top down.

But do not just take our word for it We are proud to have recently won awards for Best Culture, Production Agency of the Year and Outstanding SME in Gender Equality, Family Status Equality and Racial Equality and Inclusion. Check out tagww.com to learn more.

WHAT YOU OFFER US

This role supports the Medical Legal Regulatory (MLR) submissions and artwork production teams. As a Regulatory Specialist, you would be expected to do a thorough examination of each tactical element of artwork.

Your role requires you to consult with project managers, medical editors, and the production specialists to ensure that the claims and references are accurate and supported. Also, you would have to ensure that each piece is been created and uploaded as required by brand, style, and MLR file standards.

Your key roles and responsibilities will include:

*Checking quality and accuracy of annotations, tags/links, reference binders/packs, and edits for all advertising, promotional, and non-promotional communication materials

*To ensure accuracy of text, layout, organization and references; compliance with AMA or AP guidelines; overall logic, consistency and clarity

* Providing expertise as SME to Creative Production and the client whenever required

* Working closely with Medical Editors and Production Team to ensure that jobs are compliant with brand and expected standards

* Keep submission schedule on track all through the transition from medical editing (upload) to submission

Helping in ensuring that all files coming in are of suitable quality and are aligned with file and brand standards at the start of the project

*Keep line manager updated on the ongoing projects

Other competencies / You must have the sensibility to,

Good communication/interpersonal skills

Good understanding of online platforms

Quick learner

Fair competence in Adobe Acrobat

Good eye for detail

Basic typography skills

Proficiency in MS office

Knowledge of guidance and compliance under FDA rules and regulations (Regulatory Affairs) is preferred

Ability to coordinate and deliver effective work from teams and vendors

Ability to accurately review complex materials including multimedia graphics, texts, and web sites with excellent attention to detail

Operating effectively in a fast-paced, deadline-driven environment

GREAT TO HAVE

Bachelor’s degree in pharma/healthcare/medical technology or a related field required. Master’s degree would be an added advantage

Minimum 2+ years regulatory experience

Medical, pharmaceutical, or Life Sciences marketing experience preferred

A combination of relevant work experience and education can be substituted

Knowledge of medical/pharmaceutical terminology, and federal regulations governing pharmaceutical advertising preferred

Working knowledge of Microsoft Office and Adobe Acrobat required

Ad agency experience preferred

Enthusiasm to deliver the best and push yourself until you are happy with the output

WHERE YOU’LL FIT IN

Report to Regulatory Affairs Supervisor