Regulatory Affairs Liaison Jobs

Regulatory Affairs Liaison

Fully Remote (Must be U.S. based)

Job Summary:

Our team is seeking an organized and proactive Regulatory Affairs Liaison. As a Regulatory Affairs Liaison, you will serve as the primary point of contact between our organization and regulatory authorities, ensuring compliance with applicable regulations and maintaining effective communication channels. Your responsibilities will include managing regulatory submissions, coordinating regulatory submission activities, and providing regulatory guidance to internal stakeholders. The ideal candidate has excellent interpersonal skills, a deep understanding of regulatory processes, and the ability to navigate complex regulatory landscapes. Thorough knowledge and recent CBER experience are necessary. Experience working with monoclonal antibodies, virology, epidemiology – preferred.

Responsibilities:

• Facilitate and coordinate regulatory inspections and audits by regulatory agencies, ensuring timely response to inquiries and resolution of identified issues.
• Coordinate and manage regulatory submissions, including applications, registrations, notifications, and reports, ensuring completeness, accuracy, and adherence to specified timelines.
• Serve as the primary liaison between the organization and regulatory authorities, maintaining clear and prompt communication to ensure compliance with all applicable regulations and standards.
• Develop and maintain strong relationships with regulatory authorities, industry associations, and external stakeholders to stay informed of regulatory trends and changes.
• Participate in internal audits and assessments to identify areas of non-compliance and recommend appropriate corrective and preventive actions.
• Review and assess promotional materials, labeling, and product claims for compliance with regulatory requirements.
• Contribute to the development and improvement of regulatory processes, procedures, and documentation.
• Collaborate with cross-functional teams to gather necessary information and support for regulatory submissions and inspections.
• Keep abreast of changes in regulatory requirements and communicate updates and potential impacts to relevant departments within the organization.
• Provide regulatory guidance and support to internal stakeholders, including product development teams, quality assurance, and relevant departments.
• Assist in the development and implementation of regulatory training programs for employees to enhance awareness and compliance.
• Conduct thorough research and analysis of regulatory requirements, guidelines, and industry best practices as needed – to ensure regulatory compliance.

Qualifications:

• Bachelor's degree in a scientific discipline, pharmacy, regulatory affairs, or a related field. Advanced degree is preferred.
• In-depth knowledge of relevant national and international regulatory requirements, guidelines, and standards, such as FDA, EMA, ISO, etc.
• Familiarity with quality management systems (QMS) and regulatory compliance auditing is a plus.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Excellent communication and interpersonal skills, with the ability to effectively interact with regulatory agencies, internal stakeholders, and external partners.
• Minimum of 5 years of experience in regulatory affairs or a related field.
• Proficient in using regulatory databases, document management systems, and other relevant software tools.
• Ability to work independently and collaboratively in a cross-functional team environment.
• Strong understanding of regulatory processes and the ability to interpret and apply regulatory requirements in a practical manner.
• Experience in managing regulatory submissions and interactions with regulatory authorities.