Executive Regulatory Affairs

Job Description

Skills & Qualifications:  Bachelor of Science (or higher) in Biological Sciences, Pharmacology, Toxicology, Chemistry or related Health Sciences  Graduate Certificate in Pharmaceutical Regulatory Affairs  Must have a minimum of four years of experience filing regulatory submissions with Health Canada  Must have strong technical knowledge of CMC requirements and is able to critically analyze scientific data  Strong interpersonal skills and ability to foster strong working relationships with key stakeholders (internally and externally) and representatives from Health Canada  Strong working knowledge of Canadian Food and Drugs Act and Food and Drug Regulations, GMPs, ICH Guidelines and Health Canada Policies and Guidelines  Knowledge of the Medical Devices Regulations is an asset  Ability to prioritize workload to ensure all deadlines are met  Experience with publishing eCTD submissions is an asset  Ability to work independently with minimal supervision  Excellent organization, written and oral communication skills  Ability to effectively manage multiple projects in a fast-pace, results oriented environment  Strong commitment to quality, accuracy and detail  Ability to work well under pressure in a team based environment  Strong problem solving/analytical ability and issue resolution skills Drug Regulatory Affairs Specialist Responsibilities & Duties Develop and implement regulatory strategies to bring drugs to market in compliance with relevant laws and regulations. Conduct regulatory research and provide guidance on regulatory issues and requirements. Prepare and submit applications and regulatory submissions, such as INDs, NDAs, and BLAs. Communicate with regulatory agencies and respond to inquiries. Manage projects and timelines to ensure timely submission of regulatory documents. Work with cross-functional teams to ensure regulatory compliance throughout the product development process. Stay informed of regulatory changes and trends in the industry. Job Types: Permanent, Fresher Pay: ₹25,217.75 - ₹45,679.31 per month Benefits: Health insurance Paid sick time Provident Fund Schedule: Day shift Monday to Friday Supplemental Pay: Performance bonus Yearly bonus Work Location: In person