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Job #03211

About our client Our client is a rapidly growing pharmaceutical company headquartered in Montreal that is focused on the manufacturing and distribution of various generic brand therapeutics. The company has some of the strongest financial indicators in the industry, an experienced management team, and a robust pipeline. They also offer an empowering corporate culture that is focused on the professional development and advancement of clinical team members. Position Location Regulatory Strategy Specialist Montreal, Quebec Salary Highly competitive package, commensurate with experience Responsibilities 1) Act as an individual project contributor 2) Oversee the development, management, and implementation of regulatory strategies for specific innovative projects/products 3) Handle compounds in all phases of development and commercialization, within various therapeutic areas 4) Undertake the assessment of regulatory requirements and make recommendations on the regulatory strategy for preclinical, clinical as well as CMC 5) Manage the execution of regional regulatory strategies 6) Liaise with all stakeholders to ensure that developmental activities are aligned to regulatory strategies 7) Provide regulatory supervision in executing submissions to ensure compliance with requirements Requirements 1) Bachelor’s Degree in Pharmacology, Pharmacy, Pharmaceutical Sciences, and Chemistry/Biochemistry 2) Minimum 7 years of experience in regulatory affairs in the innovative pharmaceutical industry 3) Minimum 3 years of experience in the development/implementation of regulatory strategies for new drug products 4) Excellent organizational and time management skills 5) Superb communication skills (written and oral in English and French) 6) Good computer skills 7) Ability to work well within teams under stress 8) Ability to work independently