Company Confidential – Boston, MA
Full Time – Permanent: Hybrid for East Coast applicants
Overview
An emerging biopharmaceutical organization is seeking a Head of Regulatory Affairs to join its clinical leadership team. This executive will define and lead global regulatory strategy as the company transitions from late-stage development to its first commercial product launch. Reporting directly to the head of clinical development, this individual will oversee all aspects of regulatory affairs, including global submissions, health authority interactions, compliance, and post-approval lifecycle management.
The successful candidate will bring deep experience in drug development and global registration processes (IND, NDA, MAA, etc.), along with a strong record of successful regulatory submissions and launches. This role will play a critical part in guiding global regulatory pathways, ensuring readiness for inspection, and supporting commercialization efforts.
Responsibilities:
Regulatory Strategy & Launch Preparation
- Develop and implement global regulatory strategies to support late-stage development and registration of lead assets.
- Lead the preparation, submission, and review process for global marketing applications.
- Serve as the primary liaison with global health authorities and lead key regulatory interactions.
- Anticipate and address regulatory challenges associated with launch readiness, labeling, and post-marketing obligations.
- Align global regulatory plans with commercialization timelines and country-specific requirements.
Regulatory Operations & Compliance
- Ensure the quality, accuracy, and consistency of regulatory submissions and documentation.
- Oversee regulatory systems, tools, and infrastructure to enable global operations.
- Collaborate across functions (Clinical, CMC, Quality, and Commercial) to ensure regulatory alignment and compliance.
- Stay current with evolving international regulatory requirements and communicate implications across the organization.
Leadership & Collaboration
- Build and lead a high-performing regulatory affairs function that supports both near-term filings and long-term pipeline growth.
- Manage relationships with external consultants, CROs, and affiliates supporting regional filings.
- Partner with Quality, Supply Chain, and Commercial teams to ensure manufacturing readiness and compliant launch activities.
- Advise executive leadership on regulatory strategy and represent regulatory perspectives in corporate decision-making.
Post-Approval & Lifecycle Management
- Oversee post-marketing activities including label updates, change management, and regulatory maintenance.
- Develop strategies for new indications, line extensions, and lifecycle innovation.
Commercial Regulatory Affairs
- Provide regulatory review and guidance on promotional and marketing materials to ensure compliance with applicable laws and regulations.
- Serve as the regulatory member of cross-functional promotional review committees.
- Support interactions with relevant regulatory offices overseeing promotional communications.
Key Qualifications:
Required
- Bachelor’s degree in life sciences or related field.
- 12+ years of regulatory affairs experience within the biopharma industry.
- 7+ years in leadership roles managing internal teams and external partners.
- Proven success guiding late-stage programs through global submissions and approvals.
- Strong understanding of international regulatory frameworks (FDA, EMA, ICH, etc.).
- Demonstrated experience supporting a product launch from a regulatory perspective.
Preferred
- Advanced degree (PharmD, PhD, MS, or JD).
- Regulatory certification (e.g., RAC).
- Experience in rare disease, specialty therapeutics, or ophthalmology preferred.
- Background in biologics, combination products, or accelerated approval pathways advantageous.