Regulatory Manager Job Description

Responsibilities

• Develop and implement regulatory strategies to ensure compliance with all relevant laws, regulations, and standards
• Review and assess regulatory requirements and provide guidance to cross-functional teams
• Coordinate and prepare regulatory submissions, including pre-market applications, product registrations, and post-market surveillance
• Monitor changes in regulatory requirements and update internal processes and procedures accordingly
• Collaborate with external regulatory agencies and stakeholders to address questions and issues
• Conduct internal audits and inspections to ensure compliance with regulatory requirements
• Provide regulatory guidance and support to product development teams
• Conduct training sessions to educate employees on regulatory compliance

Qualifications

• Bachelor's degree in a relevant field (e.g., regulatory affairs, life sciences, pharmacy)
• Previous experience in regulatory affairs or a related field
• Strong knowledge of relevant laws, regulations, and standards
• Excellent understanding of the product development process
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and collaborate effectively with cross-functional teams
• Attention to detail and strong organizational skills
• Certification in regulatory affairs (e.g., RAC) is preferred

Skills

• Knowledge of regulatory requirements and standards
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Attention to detail and strong organizational skills
• Ability to collaborate effectively with cross-functional teams
• Proficiency in regulatory submission processes
• Experience with regulatory inspections and audits
• Familiarity with product development life cycle
• Certification in regulatory affairs (e.g., RAC) is preferred