Regulatory Affairs Associate

The Opportunity

The Regulatory Affairs Associate supports and implements Regulatory Affairs programs, processes, and policies to support regulatory activities for pharmaceuticals, biologics, chemical drugs, and medical devices. This role coordinates recurring regulatory activities, supports health authority submissions, maintains accurate regulatory documentation and contributes to Drugs CMC regulatory, regulatory operations, and scientific and medical writing. Working with moderate supervision, the Regulatory Affairs Associate manages routine projects, resolves operational issues and contributes to process improvements including the improvement of regulatory workflows and ensuring timely, accurate submissions. This role also provides junior-level support for the regulatory review of pharmaceutical, biologic, medical device, cosmetic and over the counter products and submission of promotional materials at time of first use.

Key Responsibilities

• Build strong, collaborative relationships with internal stakeholders, understanding their needs and providing compliant, practical solutions.
• Provide technical guidance to line managers and other colleagues.
• Prepare and deliver presentations to business partners or leadership team to communicate regulatory updates and initiatives.
• Support the administration and implementation of Regulatory Affairs programs, processes, and policies to support regulatory compliance across product categories.
• Prepare, review, submit, track and follow up on health authority filings and related regulatory documentation.
• Maintain and archive registration files in accordance with applicable procedures and record-retention requirements.
• Gather, compile, analyze and summarize data from multiple sources to support submissions, regulatory reports and compliance documentation.
• Support CMC regulatory, regulatory operations and medical-writing activities.
• Identify operational issues, interpret applicable procedures, and escalate complex matters appropriately.
• Contribute to the design and improvement of regulatory workflows, templates, tracking tools and quality controls.
• Draft, edit, format, and review scientific summaries, manuscripts, clinical study reports, monographs, presentations, and other regulatory documents.
• Prepare literature for new products and revise existing product materials.
• Conduct literature searches and maintain files of journal articles and abstracts for current and anticipated business needs.
• Review derivative materials and second/third round of advertising and promotional materials under the guidance of experienced Regulatory Affairs manager and colleagues.
• Compare promotional claims, indications, intended use, safety information, and product descriptions against current approved labeling, instructions for use, and supporting evidence.
• Check claims are truthful, accurate, adequately substantiated, and not misleading.
• Escalate inconsistent claims to senior reviewers.
• Verify the inclusion, accuracy, prominence, and presentation of required safety, risk, limitation, and fair-balance information.
• Support the implementation of approved changes and verify that final materials reflect the approved review comments.
• Assist with monitoring changes in labeling, scientific evidence, and regulatory requirements that may affect active promotional materials.
• Support preparation of applicable advertising and promotional FDA Form 2253 submissions under supervision.

Qualifications

• Bachelor's degree in Regulatory Affairs, Pharmacy, Life Sciences, or a related field, or equivalent experience/qualification.
• 3-7 years of experience in regulatory affairs, with exposure to biologicals, chemical drugs, and/or medical devices.
• Advanced knowledge of regulatory submission processes, documentation standards, and compliance requirements.
• Strong technical writing, editing, and document review skills for scientific and regulatory content.
• Experience with Drugs CMC regulatory processes, medical writing, and health authority submissions.
• Foundational knowledge of pharmaceutical, Over The Counter, Cosmetic and medical device US Advertising and Promotional requirements.
• Knowledge of regulatory submissions, documentation standards, product labeling and compliance processes.
• Excellent problem-solving skills, with the ability to resolve issues.
• Strong organizational skills, attention to detail, and commitment to accurate and timely work.
• Ability to manage assignments independently while escalating complex or higher risk matters.
• Strong interpersonal skills to build trust and influence across functions.
• Proficiency with regulatory information management systems and Microsoft Office Suite.
• Detail-oriented with a commitment to accuracy, compliance, and operational efficiency.
• Proficient in Microsoft Office Suite, Regulatory Information Management Systems, and electronic review or document-management platforms.

Physical Requirements and Work Environment

This role requires the ability to perform standard office activities, including extended periods of computer use, participation in virtual and in-person meetings, and collaboration across teams. Depending on business needs, occasional travel may be required.