Sr Manager, Reg Affairs - CMC Biologics

Senior Manager, Regulatory Affairs, CMC

Location

The position may be office based in Canada (Burlington), US (Lexington), remote across Canada or the US, or a mixture of office and remote based.

The Role

We are looking for passionate, resilient, and inspiring individuals for our Global Regulatory Affairs, Chemistry Manufacturing and Controls (RA, CMC) team, part of the Strategic Regulatory Services (SRS) group. SRS are a global team of regulatory strategists from (bio)pharma, consulting, CRO, and Agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation, CMC, and Quality Services/QA.

You are an experienced CMC and regulatory professional who can operate autonomously to provide sound CMC regulatory advice to colleagues and clients.

As a Senior Manager, RA, CMC you will be responsible for working with clients to define and execute, regulatory CMC strategy with and on behalf of clients, on a global basis. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance. You will act as a technical regulatory expert to clients and often to the rest of the CMC team, leading CMC strategy for clients to support registration (new and maintenance) in Canada, the US, and internationally. You will also lead projects, ensuring on-time and on-budget delivery of project deliverables, as well as contributing to business development activities.

We are seeking individuals with demonstrable experience in CMC regulatory affairs and a sound understanding of the technical aspects of small molecules development. You will have experience in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.

Responsibilities and Accountabilities

• Serve as a resource for the CMC and SRS team members, ICON colleagues, and clients providing advice on technical regulatory CMC aspects of drug development and product maintenance.
• Effectively manage/execute/oversee the preparation of regulatory CMC submission documents demonstrated by a deep knowledge of applicable legislation and guidelines for submission to government agencies and continued client compliance.
• Facilitate submission approvals and amendments through leading communications (face to face meetings, teleconferences, etc.) and negotiations with client, government agencies, and project teams. Build positive working relationships with clients, and government agency contacts.
• Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organisation as required. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
• Effectively manage workflow; prioritising project objectives, and establishing timeframes for projects, as well as overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
• Train, coach, and develop assigned individuals to build team expertise across various product types (technical CMC development, preparation of files, regulatory strategy, client management, agency/client communications and project management).
• 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.
• Participate actively in other business related projects (business opportunities, client specific issues etc.)

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 local environment (Europe).
• Experience supporting business development activities and people management an asset.
• Experience presenting at applicable industry conferences and/or publications in regulatory affairs.
• Certification in regulatory affairs (RAC) or post-secondary institution beneficial.