Regulatory Specialist

2+ years

Not Disclosed

Remote

10 Sept. 26, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Specialist

About Us

At Tag, we empower brands to stand out and drive sales through impactful content delivered quickly and at scale across various channels and geographies. With over fifty years of experience working with some of the world’s leading brands, we partner with clients to create efficient, effective work that tells a compelling story.

We believe that diversity in ideas, experiences, and skillsets creates a thriving workplace. Our culture is built on core values of integrity, innovation, sustainability, growth, and accountability. We are dedicated to fostering an inclusive, equitable, and diverse environment. Our global DE&I committee and leadership team actively promote increased representation and accountability to drive positive change throughout the organization.

We’re proud of our recent awards for Best Culture, Production Agency of the Year, and Outstanding SME in Gender Equality, Family Status Equality, and Racial Equality and Inclusion. Learn more at tagww.com.

What You Bring to Us

In this role, you will support the Medical Legal Regulatory (MLR) submissions and artwork production teams. As a Regulatory Specialist, your primary responsibility will be to thoroughly examine each element of artwork to ensure compliance and accuracy.

Key Responsibilities:

Review quality and accuracy of annotations, tags/links, reference binders, and edits for all advertising, promotional, and non-promotional materials.
Ensure text, layout, organization, and references meet compliance standards (AMA or AP guidelines), while maintaining overall logic, consistency, and clarity.
Serve as a Subject Matter Expert (SME) for Creative Production and clients as needed.
Collaborate closely with Medical Editors and the Production Team to ensure compliance with brand and regulatory standards.
Maintain submission schedules throughout the transition from medical editing to final submission.
Ensure incoming files meet quality and brand standards at the project’s outset.
Keep the line manager updated on project progress.

Additional Competencies:

Strong communication and interpersonal skills.
Good understanding of online platforms.
Quick learner with a keen eye for detail.
Basic typography skills and proficiency in MS Office.
Fair competency in Adobe Acrobat.
Knowledge of FDA rules and regulations (Regulatory Affairs) is preferred.
Familiarity with VEEVA Vault is a plus.
Ability to coordinate effectively with teams and vendors.
Capacity to accurately review complex materials, including multimedia graphics and texts, with excellent attention to detail.
Comfortable working in a fast-paced, deadline-driven environment.

Great to Have:

Bachelor’s degree in pharma, healthcare, medical technology, or a related field (Master’s degree is a plus).
Minimum of 2+ years of regulatory experience.
Experience in medical, pharmaceutical, or life sciences marketing preferred.
Knowledge of medical/pharmaceutical terminology and federal regulations governing advertising is a plus.
Prior ad agency experience is preferred.
Enthusiasm for delivering high-quality work and a commitment to continuous improvement.

Where You’ll Fit In:

You will report to the Regulatory Affairs Supervisor.

Location:

Positions available in Chennai and Bangalore.

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Regulatory Specialist

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