Global Regulatory Lead, Senior Director

Ciao! At  Dompé , our success is rooted in our team and our history. We are a private, rapidly growing global biopharmaceutical company.  Founded in Milan, Italy, we have a 130-year legacy of medical innovation. Dompé’s rich history has greatly influenced its priorities today: to innovate for the benefit of patients facing both everyday wellness needs and rare conditions. Dompé operates in two strategic areas in select markets around the world: Primary Care, which includes prescription and over-the-counter products; and Biotechnology and Rare Disease, which recently expanded into the United States. 

Today Dompé has over 950 employees worldwide and we are excited to be rapidly scaling in the United States. Our R&D hub is currently based in Boston, and the commercial organization is housed in the San Francisco Bay Area. 

POSITION SUMMARY:
Dompé is seeking a Global Regulatory Lead, Senior Director that will play a critical role in developing and executing global regulatory strategies to support product development, registration, and compliance. Reporting to the Vice President of Regulatory Affairs, this position will serve as a key liaison with regulatory health authorities, oversee regulatory submissions, and provide strategic guidance to cross-functional teams. The ideal candidate will have extensive experience in regulatory affairs within the pharmaceutical or biotech industry, a strong understanding of U.S. and international regulations, and the ability to navigate complex regulatory environments to drive successful outcomes.

Primary Objectives:

• Develop and Execute Regulatory Strategies – Provide regulatory expertise across early and late-stage clinical development, ensuring compliance with U.S. and international requirements.
• Lead Regulatory Submissions and Compliance – Oversee the preparation, submission, and management of investigational and registration applications (eCTD) while coordinating with Regulatory Operations for e-submissions.
• Risk Assessment and Cross-Functional Collaboration – Identify and escalate regulatory risks, ensuring seamless collaboration across teams to drive successful regulatory outcomes.

Ideal Candidate Profile:

• Deep understanding of global regulatory frameworks (FDA, EMA, ...)
• Expertise in IND, CTAs, NDAs, BLAs and regulatory pathways (Orphan Drug Designation,...)
• Ability to develop and translate regulatory strategies into actionable global development plans.
• Ability to manage multiple priorities, assess risks, and navigate complex regulatory environments with precision and flexibility.
  

Why This Opportunity:
Joining Dompé as a Global Regulatory Lead, Senior Director offers a unique opportunity to be part of a rapidly growing global biopharmaceutical company with a rich history of innovation. This role provides the chance to lead regulatory strategies for groundbreaking therapies, collaborate with cross-functional teams, and engage directly with health authorities to drive successful product approvals. With a dynamic and entrepreneurial culture, Dompé fosters professional growth, values strategic thinking, and empowers its employees to make a meaningful impact on global healthcare. If you thrive in a fast-paced, high-impact environment and are passionate about advancing innovative treatments, this is the perfect opportunity for you.

RESPONSIBILITIES:

• Support Global Product Teams by contributing to and implementing regulatory strategies to optimize global product development and registration activities.
• Manage regulatory communications/interactions with regulatory health authorities and ensure compliance with applicable regional regulations for assigned development projects in the US and ex-US countries.
• Represent the Regulatory Affairs department on multidisciplinary product development teams.
• Serve as primary point-of-contact for communication with regulatory health authorities on assigned programs.
• Lead team preparations for milestone development/registration meetings with regulatory health authorities.
• Contribute content and collaborate cross-functionally for preparation of CTA/IND/NDA/BLAs, amendments/variations, safety, and annual reports.
  
• Coordinate with external vendors to maintain registration and lifecycle of assigned products globally.
• Support investigational studies, i.e., protocol review, IND/CTA regulatory documents preparation, review, submission and maintenance, CSR review.
• Prepare strategy for orphan drug designations, pediatric study plan and acceleration pathway applications if applicable for the assigned projects.
• Proactively prioritize and complete multiple projects within established deadlines.
• Maintain awareness of evolving FDA and international regulations and interpretation, competitive landscape, regulatory precedents, and work cross-functionally to implement those evolved regulations for the assigned projects.

QUALIFICATIONS:

• Doctorate degree and 10+ years in the pharmaceutical, biotech, or related industries and 8+ years of regulatory affairs.
• Master’s degree and 12+ years in the pharmaceutical, biotech, or related industries and 10+ years of regulatory affairs.
• Bachelor’s degree and 14+ years in the pharmaceutical, biotech, or related industries and 12+ years of regulatory affairs.
• Pre- and post-approval and lifecycle management experience.
• Previous experience with SharePoint, Veeva, PleaseReview, eTMF.
• Strong understanding of US and EU regulations.
• Proficient regulatory writing skills
• Strong written and verbal communication, analytical, organizational, and people skills to enable cross-functional collaboration.
• Practical knowledge of early and late-stage clinical development programs and current US and ex-US regulatory requirements for quality, preclinical, and clinical.
• Direct experience with investigational/registration applications in eCTD format and management of clinical trials in applicable regulatory portals (CTIS, eTMF, RIM).
• Familiarity coordinating with Regulatory Operations group for compilation and e-submission of regulatory documents.
• Risk assessment and appropriate escalation to the line manager and senior leadership team.

Base Salary: $260,000 - $285,000 a year

At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.