Job Description
About the Opportunity:
We are seeking a highly accomplished Senior Vice President–level Regulatory Affairs Consultant to immediately join our executive leadership function and provide high-level regulatory oversight across a rapidly expanding and confidential portfolio.
This opportunity is designed for an elite regulatory professional who can operate autonomously with minimal direction and deliver immediate impact. Due to the urgency of current regulatory timelines, onboarding will be expedited.
This engagement supports multiple undisclosed assets spanning small molecules, biologics, oncology, and next-generation therapeutic platforms, with significant executive visibility and decision-making authority from day one.
Role Overview:
As a senior regulatory executive, you will serve as the primary regulatory authority for the organization, overseeing global strategy and execution across all programs. You will independently guide regulatory direction, approve submissions, and act as the main point of contact for regulatory agencies as required.
Key Responsibilities
- Define and approve global regulatory strategy across development programs at all stages.
- Oversee preparation and final sign-off of INDs, NDAs, BLAs, and international submissions.
- Interface directly with FDA and global health authorities as needed.
- Provide regulatory guidance on clinical strategy, labeling, CMC, and lifecycle considerations.
- Ensure compliance with evolving regulatory expectations across regions.
- Review and authorize regulatory documentation and external vendor invoices.
- Maintain confidentiality of sensitive regulatory and corporate information.
Qualifications & Experience
- Senior-level experience in Regulatory Affairs within biotech or pharmaceutical settings preferred.
- Prior FDA interaction experience beneficial but not required.
- Strong decision-making and document approval capabilities.
- Ability to manage confidential materials independently.
- Access to personal computer and secure financial account for reimbursement processing.
- Availability to begin immediately.
What We Offer (Package & Benefits)
- Weekly direct compensation payments.
- Signing bonus issued upon onboarding completion.
- Company equipment provided following initial administrative processing.
Why Join This Organisation?
- Immediate placement in a senior executive regulatory role.
- Minimal time commitment with maximum strategic influence.
- Opportunity to oversee a broad, confidential pipeline with global scope.
- High compensation aligned with trust and autonomy.