Job Description

Job Title: Global Regulatory Affairs Lead (GRL)

Job Type: Full-time, permanent position

Location: Toronto, Ontario, Canada – Remote/Hybrid

Salary: Attractive salary plus benefits package

Working for one of the industry’s leading pharmaceutical companies, this is a fantastic opportunity to provide expert regulatory knowledge from pre-clinical through clinical studies to initial registration in key global markets. You will be ‘the face’ of the Global Regulatory function on cross-functional global project teams for new product introductions and a single point of accountability for Global Regulatory Strategy Leadership and policy development.

The business is looking for someone who is confident in phase 3 of drug development and is successful in licensing new drugs into global markets. You will sit within the Pharmaceutical Diagnostics division however will only be managing the molecules as opposed to the device. The business has assets ranging from pre-clinical through to late stage and you will be responsible for all regulatory activities related to your assigned asserts.

Role responsibilities:

• Lead all licensing/filling activities assigned to the development portfolio.
• Drive global Regulatory Affairs strategies for the portfolio, including managing internal and external stakeholders.
• Lead interactions with the health authorities/ local agencies – MHRA, EMA & FDA. This will be including pre submission meetings, pre-IND meetings, Scientific advice and type B/C meetings with the FDA.
• Support both early and late-stage development activities CTAs, IND, ODD, PIPS, IND, IMPD, and initial MAAs.
• Confident in doing submissions in global markets with a main focus on the EU, US, and China.
• Working with NRA, ensure timely GRA input to global development programs.
• Support and lead cross functional team discussions with medical, quality, PV, and other departments.
• Fulfilment of regulatory compliance obligations.
• Support assets from pre-clinical, phase 1, 2, and 3.

Requirements:

• A PhD qualified profile is desirable but not a must.
• Proven track record of leading successful European (CP, DCP, MRP), European national and US NDA/BLA licensing submissions.
• Previous experience focused on phase 3 and leading licensing activities globally.
• Extensive initial MAA/ NDA/BLA experience.
• Proven track record of leading successful interaction with HA and relevant stakeholders.
• Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory strategy document (GRSD) delivery.
• Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs.
• Ability to clearly convey and exchange information with internal and external stakeholders.

This role is a very senior role within the regulatory team and the business are looking for a wealth of experience across the drug development cycle. You will have a sound understanding of the Oncology space, be able to devise strategies in line with business requirements globally and be able to influence at a high level internally and externally.

You must have experience with submissions in global regions, especially the US, EU, and ideally China.

For more information, please contact lucy.kirkaldy@cpl.com

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