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 division; however, you will only be managing the molecule as opposed to the device. With the businesses having a lot of late-stage assets, you MUST have prior experience leading an initial MAA/NDA submission. 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:
- Lead all licensing/filing activities assigned to the development portfolio. (Initial MAA/NDA)
- 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 include 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 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 [email protected]