Job Details

POSITION SUMMARY

Global Regulatory Lead, Senior Director role at Dompé is to 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 27s degree and 12+ years in the pharmaceutical, biotech, or related industries and 10+ years of regulatory affairs.


• Bachelor 27s 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.


• 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 progams 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.

COMPENSATION & BENEFITS

Base Salary: $265,000 - $295,000 a year

At Dompé, 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.

Benefits

• Comprehensive medical benefits: we value access to healthcare for our patients as well as our employees


• Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle


• Competitive 401(K) matching


• A super cool team who19s excited to transform lives through innovative therapies

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Biotechnology Research and Pharmaceutical Manufacturing