General Manager

2 weeks ago


Old Toronto, Canada Amicus Therapeutics Full time
p>Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.Create and effectively execute the Affiliate business strategy delivering on the Corporation’s strategic aims whilst adhering to international, local, and internal laws, codes, and SOPs.Be a champion for excellence in good Governance across all Legal, Compliance, Safety, and Quality requirements associated with the Pharma/Biotech industry.Increase the business performance in the country market by: Industry Association Groups and Networks Provide strong leadership, direction, and development in line with Amicus behaviours to ensure employees are engaged, able to excel in their performance, and ultimately fulfil their potential.Work effectively and in partnership with other international functions (e.g., Marketing, Finance, HR, Legal, Compliance, etc.).Compliance with all company and local regulations, alignment with local Code of Conduct, including adverse events, product complaints, and pregnancy reports according to company procedures.Manage the legal entity of Amicus Therapeutics in Canada in line with the governance structure.Create a clear focus on activities that drive patient access working in close cooperation with key medical centres.Be responsible for the implementation of agreed Global/International strategies and tactics.Regulatory, Clinical Operations, Medical and PV: Working with regulatory, pharmacovigilance, and medical affairs, ensure marketing authorization requirements are met around safety and pharmacovigilance for commercial.Quality: Working with the Head of Quality, International and the named Responsible Person in Quality, ensure compliance with GMP and GDP regulations.Legal and Compliance: Working with Legal International to manage requirements for UK and Ireland affiliate business, oversight of contracting with third partners and service providers. Ensure legal and ethical compliance via company policies and procedures.Supply Chain: Working with global supply and CMC to ensure a reliable, continuous supply of product from local manufacturing, wholesalers, and warehousing UK and Ireland customers. Report market shortages to the relevant regulatory authorities.Medical: Dual reporting line responsibility for the country Medical Director and supporting the oversight of the affiliate Medical Team.Educational/Professional Work Experience Requirements/Experience and Skills Solid experience in working with rare diseases or specialty care products and demonstrates a good understanding of the science behind the product.Comprehensive understanding of the local rules and regulations of the pharma market in the country of responsibility.A passion for helping patients with rare diseases.Solid judgment and business acumen and understanding of multi-national business operations.Strong organizational skills with the ability to prioritise and manage multiple time-sensitive projects simultaneously.Strong verbal and written skills with the ability to explain complex, challenging issues in a clear manner to all levels of the organization, especially senior management.Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).Fluency in English and local language for the country of responsibility is essential.Regular International, regional, and domestic travel will be required.
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