Senior Regulatory Affairs Associate – Regulatory Intelligence

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Oversee the regulatory intelligence platform and various information sources to discover and monitor new and evolving regulations, guidelines, standards, and policies from international regulatory authorities.

• Evaluate regulatory content for relevance, distribute approved materials to key stakeholders for impact assessment and gap analysis, and refresh stakeholder distribution lists.

• Collaborate with subject matter experts to evaluate the implications of regulatory changes on products, development pipelines, and business operations.

• Monitor the execution of impact assessments and gap analyses with key stakeholders.

• Analyze and report on compliance metrics for impact assessments, following up on risk-mitigation actions.

• Utilize the AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize GxP-related content, and update AI taxonomy terms.

• Participate in audits and inspections by providing evidence of regulatory intelligence tracking and impact assessments.

• Maintain knowledge of global standard operating procedures and working procedures within the document management system.

• Coordinate with Information Technology, Regulatory Technology, and the platform vendor regarding technical issues, access requests, and distribution concerns.

• Keep abreast of regulatory intelligence trends and technologies, sharing insights to enhance compliance activities.

⛳️ Requirements

• A minimum of 2 years of experience in regulatory intelligence.

• A Bachelor's degree in a scientific or technical field.

• Prior experience in analyzing and reporting compliance metrics.

• Thorough understanding of drug, biologic, and device development processes, along with knowledge of the laws, regulations, and guidelines from the FDA, EMA, PMDA, and ICH.

• Capability to plan, direct, organize, and manage projects effectively.

• Exceptional interpersonal skills with strong written and verbal communication abilities.

• Strong critical thinking and problem-solving skills.

• A results-driven, team-oriented collaborative approach.

• Proven experience with Microsoft Office applications (Word, Excel, PowerPoint, Outlook).

• Background in clinical research, healthcare, or a regulated environment.

• Comfort with AI-enabled regulatory intelligence platforms, document management systems, and Microsoft Office tools.

• Preferred: At least 2 years of experience in regulatory affairs.

• Preferred: Prior interactions with the FDA or other health authorities.

• Preferred: Experience in pharmacovigilance or regulatory work related to pharmacovigilance.

• Preferred: Previous experience in developing newsletters.

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Tuition Reimbursement.

• Vacation/Holiday/Sick Time.

• Flexible Spending & Health Savings Accounts.

• Work/Life Balance.

• 401(k) with company match.

• Pet Insurance.

• Some roles may also qualify for additional incentives, bonuses, or other compensation programs.