Reporting to the Vice President of Medical & Scientific Affairs, the Senior Manager, Regulatory Affairs will be responsible for leading and/or assisting in the development of regulatory strategies and managing regulatory activities, as they relate to a variety of functions within Cipher’s organization. The Senior Manager, Regulatory Affairs is also responsible for the maintenance of regulatory compliance for assigned products by applying criteria and standards by which Health Authorities govern marketed products.
For assigned products:
• Lead or contribute to the development and implementation of regulatory strategies.
• Monitor, evaluate and interpret applicable regulatory requirements and ensure that regulatory submissions comply with current regulations.
• Manage and prepare regulatory submissions for Health Authorities, ensuring content is complete, accurate and formatted properly.
• Manage the submission process for new drug applications, supplements, clinical trial applications, application amendments and updates in support of business objectives.
• Maintenance of approved applications, including annual reports and submission of PSURs.
• Review and assess documents required to support regulatory activities and conduct assessment to determine if submission is required to Health Authorities, i.e., CMC related Change Controls.
• Develop and maintain effective working relationships with key stakeholders. These include Health Authorities such as Health Canada and the FDA, Canadian and global business partners, as well as external consultants.
• Act as the primary contact for Health Authorities, on behalf of Cipher. Develop draft responses to Health Authorities, and/or review responses and documents intended for submission to ensure compliance with regulatory standards.
• Provide regulatory input and guidance to cross-functional project teams both internally and with external vendors.
• Contribute to the development of well-defined and efficient regulatory processes and procedures.
• Coach, mentor, and influence others to take positive action and accountability for their work.
• Bachelor’s degree in a science-related discipline
• At least 5-7 years of relevant experience in pharmaceutical Regulatory Affairs, preferably with a focus on CMC
• Strong working knowledge of Canadian and/or US regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products
Additional Skills and Competencies:
• Works independently with minimal supervision
• Effective project management, time management and organizational skills (ability to coordinate and manage multiple projects and priorities simultaneously)
• Ability to learn quickly and adapt to a rapidly changing fast paced environment.
• Proficient computer skills, including all MS Office applications
• Attention to Detail – Diligently attends to details and pursues quality in accomplishing tasks.
• Creative & Innovative Thinking – Develops fresh ideas that provide solutions to all types of workplace challenges while staying within the parameters of good practice.
• Results Focus & Initiative – Focuses on results and desired outcomes and how best to achieve them.
• Effective Communication Skills (both verbal and written).
• Decision Making & Judgment – Makes timely, informed decisions that take into account the facts, goals, constraints, and risks.
• Relationship Building – Builds constructive working relationships.
Interested candidates please forward your resume and cover letter to [email protected] We will be looking to fill the position immediately.