Regulatory Affairs Manager

Role & responsibilities

• Develop and implement regulatory strategies to support research projects and product development initiatives.
• Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards.
• Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements.
• Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables.
• Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements.
• Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions.
• Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed.
• Participate in internal and external audits and inspections related to regulatory compliance.
• Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation

Qualifications

• Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred.
• Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry.

Skills

• Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams.
• Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.