Director, Regulatory Affairs CMC

Director, Regulatory Affairs CMC

Location

The position may be remote based across the US, CAD, or EU, or a mixture of office and remote based.

The Role

The Director, Regulatory Affairs, provides knowledge on CMC strategy within the Global Regulatory Affairs team which forms part of our Strategic Regulatory Services Group.

As the Director CMC, you will participate in the provision of Regulatory CMC expertise in strategic drug development across multiple areas. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance. This position will focus on the development of Biologics and Cell/Gene Therapy.

Responsibilities

• Serve as a technical expert in development, testing and manufacturing of advanced therapy medicinal products (ATMP) and resource to ICON colleagues, and clients providing advice
• Effectively manage the preparation of regulatory CMC submission documents
• Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams.
• Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required.
• Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
• Enthusiastically monitors for new regulatory requirements and shares key findings.
• Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.

Education/Experience

• Bachelors degree in a relevant discipline, preferably in a life sciences, or other healthcare field.
• Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.
• Relevant experience i.e. pharmaceutical, biologics with regulatory experience in the global environment (e.g. Europe, US, Japan, China).
• Technical development, testing and manufacturing of advanced therapy medicinal products (ATMP)
• Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.
• Experience supporting business development activities and people management an asset.
• Certification in regulatory affairs (RAC) or post-secondary institution beneficial.