Direct message the job poster from Blackfield Associates

Senior International Consultant - Regulatory Affairs and Executive search

Blackfield Associates are partnered with a clinical and early commercial biotechnology company, who due to growth and market expansion, are looking for a seasoned and highly capable Global Regulatory Lead to join our team.

The key focus for this GRL will be ownership of global regulatory strategy and execution across both development and lifecycle management phases for assigned products, ensuring successful marketing approval.

As Global Regulatory Lead, your responsibilities include:

• Provide regulatory leadership on a global scale for assigned development and the marketed products throughout their lifecycle
• Design and deliver innovative, regulation-aligned strategies to meet development and commercial goals, working with Kol’s to deliver cross-functionally
• Serve as Regulatory Affairs representative on cross-functional program teams
• Lead the planning and execution of major global submissions, including New MAA, NDA, CTA, IND, PIP/PSP, and line extensions; ensuring regulatory dossiers are strategically positioned and aligned
• Oversee submission timelines and consult with publishing teams to ensure high-quality documentation
• Act as point of contact for European and Global regulatory agencies as needed for designated programs
• Monitor project priorities and execution against regulatory plans or regulatory risks

To be considered for the role of Global Regulatory Lead, your background should include:

• Educated to degree level in a related scientific field, advanced degree ideally
• Minimum 10 years direct regulatory affairs experience, gained within pharmaceutical or biotechnology sector
• Proven leadership in regulatory product strategy with recent, hands-on experience managing regulatory submissions and maintaining approvals in the EU/UK - US regulatory experience is highly desirable
• Expertise in global regulatory frameworks, spanning development through post-approval activities- focus on Phase 2 and Phase 3 is of special interest
• Strong interpersonal and negotiation skills with a demonstrated ability to build and implement successful regulatory strategies- leading and contributing towards commercialisation of a new asset
• Open to therapeutics areas, but candidates with Rare Disease, Oncology and Novel therapeutics are highly desirable

This is a hybrid working position- candidates must be located within a reasonable commute of central London office; enabling 3 days a week onsite.

Unable to Sponsor – all applicants must hold valid Right to Work.

Permanent member of Staff. Salary to be disclosed.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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