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Key Responsibilities and Required Skills for a Regulatory Associate

💰 $65,000 - $95,000

Regulatory AffairsPharmaceuticalBiotechnologyMedical DevicesComplianceLife Sciences

🎯 Role Definition

The Regulatory Associate serves as a foundational member of the Regulatory Affairs department, responsible for executing key tactical operations that support the company's product development and lifecycle management goals. This position involves close collaboration with cross-functional teams including Clinical, Quality, and R&D to compile and maintain high-quality regulatory submissions. The ideal candidate will be a proactive problem-solver with a keen eye for detail, helping to ensure that our products meet all necessary legal and scientific standards for approval and marketing.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Regulatory Affairs Intern / Co-op
  • Quality Control / Quality Assurance Associate
  • Research and Development (R&D) Assistant
  • Clinical Research Coordinator

Advancement To:

  • Senior Regulatory Associate
  • Regulatory Affairs Specialist
  • Regulatory Affairs Manager

Lateral Moves:

  • Quality Assurance Specialist
  • Clinical Research Associate
  • Medical Writer
  • Project Manager

Core Responsibilities

Primary Functions

  • Prepare, compile, and review comprehensive regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and 510(k)s, for timely submission to global health authorities like the FDA and EMA.
  • Maintain and manage regulatory files, records, and information management systems (RIMs) to ensure all documentation is accurate, current, and readily accessible for audits and inquiries.
  • Coordinate the collection, organization, and evaluation of essential documents from cross-functional teams such as R&D, Clinical, Manufacturing, and Quality for inclusion in regulatory filings.
  • Assist in authoring and preparing responses to deficiency letters and information requests from regulatory agencies, ensuring they are addressed in a thorough and timely manner.
  • Review and approve product labeling, advertising, and promotional materials to ensure full compliance with applicable regulations and company policies.
  • Support the lifecycle management of approved products by preparing and submitting annual reports, amendments, supplements, and renewals.
  • Interpret and communicate new or updated global regulatory requirements, guidance documents, and industry standards to internal stakeholders to ensure ongoing compliance.
  • Assist senior regulatory staff in developing and executing regulatory strategies for new product development projects and post-approval changes.
  • Ensure all regulatory activities are conducted in compliance with cGMP, GCP, and GLP standards as well as internal Standard Operating Procedures (SOPs).
  • Track submission timelines, project milestones, and regulatory agency interactions, proactively identifying and communicating potential risks or delays to project teams.
  • Author, review, and maintain regulatory-specific SOPs to ensure departmental processes are consistent, efficient, and compliant.
  • Provide regulatory guidance and support to project teams throughout the entire product development lifecycle, from preclinical research through post-market activities.
  • Support the preparation and maintenance of technical files and design dossiers required for CE marking and other international product registrations.
  • Conduct thorough regulatory risk assessments for proposed changes to products, manufacturing processes, or quality systems and provide actionable recommendations.
  • Manage the process for obtaining and maintaining establishment registrations, device listings, and other necessary operational licenses.

Secondary Functions

  • Support internal and external audits and inspections by retrieving necessary regulatory documentation and providing subject matter input.
  • Participate in regulatory intelligence activities by monitoring competitor approvals, new legislation, and industry trends to inform strategic planning.
  • Assist in the review of clinical trial protocols, informed consent forms, and clinical study reports to ensure they meet regulatory agency expectations.
  • Collaborate with global regulatory counterparts and distributors to support international submission strategies and ensure regional requirements are met.
  • Handle the submission of advertising and promotional materials to relevant review bodies, such as the FDA's Office of Prescription Drug Promotion (OPDP).
  • Support post-market surveillance activities, including the regulatory assessment of adverse events, product complaints, and potential recalls.
  • Contribute to the organization's data strategy and roadmap by ensuring regulatory data integrity.

Required Skills & Competencies

Hard Skills (Technical)

  • Regulatory Knowledge: Deep understanding of global regulations and guidelines (e.g., FDA 21 CFR, EMA directives, ICH guidances).
  • Submission Formatting: Proficiency with electronic submission formats, particularly the eCTD (electronic Common Technical Document).
  • Technical Writing: Ability to author and review complex scientific and regulatory documents with clarity and precision.
  • Regulatory Software: Experience with Regulatory Information Management (RIM) systems and e-submission publishing tools.
  • Microsoft Office Suite: Advanced proficiency in Word, Excel, PowerPoint, and Adobe Acrobat for document creation and management.

Soft Skills

  • Attention to Detail: Meticulous and precise in all aspects of work, from reviewing documents to compiling data for submissions.
  • Organizational Skills: Exceptional ability to manage multiple projects, prioritize tasks, and meet tight deadlines in a fast-paced environment.
  • Communication: Excellent written and verbal communication skills for effective interaction with internal teams and regulatory agencies.
  • Problem-Solving: Strong analytical and critical-thinking skills to identify regulatory risks and develop effective solutions.
  • Collaboration & Teamwork: Proven ability to work constructively with cross-functional teams to achieve common goals.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's Degree in a scientific or health-related discipline.

Preferred Education:

  • Master's Degree or other advanced degree (e.g., PharmD, PhD).
  • Regulatory Affairs Certification (RAC).

Relevant Fields of Study:

  • Life Sciences (Biology, Chemistry, Biochemistry)
  • Pharmaceutical Sciences
  • Biomedical Engineering
  • Health Sciences

Experience Requirements

Typical Experience Range:

  • 1-3 years of direct experience in a regulatory affairs, quality assurance, or related role within the pharmaceutical, biotech, or medical device industry.

Preferred:

  • Direct hands-on experience compiling and submitting major regulatory filings (e.g., IND, NDA, 510(k)).
  • Experience interacting with health authorities such as the FDA or EMA.
  • Familiarity with the full product development lifecycle.
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