Global Regulatory Affairs Lead

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 be the single point of accountability for Global Regulatory Strategy Leadership and policy development.

The business seeks someone confident in phase 3 drug development and successful in licensing new drugs into global markets.

You will sit within Pharmaceutical Diagnostics but will manage only the molecule, not the device. The assets range from pre-clinical to late-stage, and you will be responsible for all regulatory activities related to your assigned assets.

Role responsibilities:

1. Lead licensing and filing activities assigned to the development portfolio.
2. Drive global Regulatory Affairs strategies, managing internal and external stakeholders.
3. Lead interactions with health authorities and local agencies such as MHRA, EMA, and FDA, including pre-submission meetings, pre-IND meetings, scientific advice, and type B/C meetings with the FDA.
4. Support early and late-stage development activities, including CTAs, IND, ODD, PIPS, IMPD, and initial MAAs.
5. Confidently handle submissions in global markets, primarily focusing on the EU, US, and China.
6. Collaborate with NRA to ensure timely GRA input to global development programs.
7. Support and lead cross-functional team discussions with medical, quality, PV, and other departments.
8. Ensure regulatory compliance obligations are fulfilled.
9. Support assets across pre-clinical to phase 3 development stages.

Requirements:

1. A PhD qualification is desirable but not mandatory.
2. Proven success in leading European (CP, DCP, MRP) and US NDA/BLA licensing submissions.
3. Experience focused on phase 3 and global licensing activities.
4. Proven ability to interact effectively with health authorities and stakeholders.
5. Knowledge of regulatory frameworks and external environments relevant to global regulatory strategy documents.
6. Ability to develop innovative regulatory approaches to expedite product submissions.
7. Excellent communication skills for internal and external stakeholder engagement.
8. Extensive experience across the drug development cycle, especially in Oncology.
9. Strategic thinking aligned with global business requirements and high-level influencing skills.