Regulatory Affairs Manager

Title: Regulatory Affairs Manager
Location: Remote
Type: Permanent Salary: 120K – 140K plus 10-20% discretionary bonus Requirements Bachelor's degree in life sciences or related field; advanced degree preferred. Minimum of 3-5 years of experience in operational regulatory affairs within the biotech, preferably in oncology. Writing Canadian and US submissions (BGTD experience) eCTD experience required (package used is off the shelf product) Strong knowledge of global regulatory requirements and guidelines for drug development. Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions. Proven ability to manage multiple projects simultaneously and meet tight deadlines. Detail-oriented with a strategic mindset and problem-solving skills. Responsibilities Develop and implement regulatory strategies to support the development and commercialization of oncology products. Prepare and submit regulatory submissions to health authorities, including INDs, CTAs, NDAs, and marketing applications. Coordinate and liaise with cross-functional teams to ensure regulatory compliance throughout the product lifecycle. Keep abreast of regulatory changes and updates relevant to the oncology industry, providing guidance to internal stakeholders. Represent the company in interactions with regulatory agencies and support regulatory inspections and audits. Manage regulatory documentation and maintain compliance with applicable regulations and standards.