Job Title: Global Regulatory Affairs Lead (GRL)
Job Type: Full-time permanent position
Location: UK or Europe – Hybrid/remote-based role
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; however, will only be managing the molecule 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 assets.
Role responsibilities:
1. Lead all licensing/filling activities assigned to the development portfolio.
2. Drive global Regulatory Affairs strategies for the portfolio, including managing internal and external stakeholders.
3. Lead interactions with health authorities/local agencies – MHRA, EMA & FDA, including pre-submission meetings, pre-IND meetings, scientific advice, and type B/C meetings with the FDA.
4. Support both early and late-stage development activities CTAs, IND, ODD, PIPS, IND, IMPD, and initial MAAs.
5. Confident in doing submissions in global markets with a main focus on the EU, US, and China.
6. Working with NRA, ensure timely GRA input to global development programs.
7. Support and lead cross-functional team discussions with medical, quality, PV, and other departments.
8. Fulfil regulatory compliance obligations.
9. Support assets from pre-clinical, phase 1, 2, and 3.
Requirements:
1. A PhD qualified profile is desirable but not a must.
2. Proven track record of leading successful European (CP, DCP, MRP), European national and US NDA/BLA licensing submissions.
3. Previous experience focused on phase 3 and leading licensing activities globally.
4. Extensive initial MAA/NDA/BLA experience.
5. Proven track record of leading successful interaction with HA and relevant stakeholders.
6. Knowledge of regulatory frameworks and external environments as it applies to project-specific global regulatory strategy document (GRSD) delivery.
7. Ability to drive new regulatory approaches to improve and expedite development product submissions to meet business/project objectives and patient needs.
8. Ability to clearly convey and exchange information with internal and external stakeholders.
This role is a very senior position within the regulatory team, and the business is 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.
For more information, please contact lucy.kirkaldy@cpl.com
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