Executive Regulatory Affairs

As a Drug Regulatory Affairs Specialist, you will play a crucial role in developing and implementing regulatory strategies to bring drugs to market in compliance with relevant laws and regulations. Your responsibilities will include conducting regulatory research, providing guidance on regulatory issues, and preparing and submitting applications and regulatory submissions such as INDs, NDAs, and BLAs. You will also be tasked with communicating with regulatory agencies, managing projects and timelines, and collaborating with cross-functional teams to ensure regulatory compliance throughout the product development process. It is essential for you to stay informed of regulatory changes and trends in the industry to excel in this role. Key Responsibilities: - Develop and implement regulatory strategies for drug market entry - Conduct regulatory research and provide guidance on requirements - Prepare and submit regulatory applications and submissions - Communicate with regulatory agencies and respond to inquiries - Manage projects and timelines for timely submission of documents - Collaborate with cross-functional teams for regulatory compliance - Stay updated on regulatory changes and industry trends Qualifications Required: - Bachelor of Science (or higher) in Biological Sciences, Pharmacology, Toxicology, Chemistry, or related Health Sciences - Graduate Certificate in Pharmaceutical Regulatory Affairs - Minimum of four years of experience filing regulatory submissions with Health Canada - Strong technical knowledge of CMC requirements and ability to analyze scientific data critically - Strong interpersonal skills to build relationships with key stakeholders and regulatory representatives - Working knowledge of Canadian Food and Drugs Act, Food and Drug Regulations, GMPs, ICH Guidelines, and Health Canada Policies - Knowledge of Medical Devices Regulations is an asset - Ability to prioritize workload and meet deadlines - Experience with publishing eCTD submissions is an asset - Excellent organization, communication, and problem-solving skills - Ability to work independently, under pressure, and in a team-based environment - Strong commitment to quality, accuracy, and detail In addition to the above qualifications and responsibilities, the company provides benefits such as health insurance, paid sick time, and a provident fund. The work schedule is in-person during the day shift from Monday to Friday, with opportunities for performance bonuses and yearly bonuses. This position offers a permanent role and is open to both experienced candidates and freshers who meet the qualifications and are eager to excel in drug regulatory affairs.,