YOUR ROLE AT DOMPÉ: REGULATORY AFFAIRS, DIRECTOR

We seek enthusiastic, resilient professionals to join Dompé’s US regulatory affairs department. The candidate reports to the Global Regulatory Affairs Senior Director and will play an important role within the Regulatory Affairs organization.

As one of the team members for Regulatory Affairs in Dompé, you will 

• Support the global regulatory affairs senior director in executing regulatory strategies for the assigned post-approval projects for US and ex-US countries (Europe, Switzerland, Canada, China, Australia).

• Prepare and deliver high-quality post-approval changes such as PAS, CBE-30, CBE-0 related supply, and label update submission for the approved BLA 

• Review and evaluate change control to provide a regulatory assessment

• Conduct a thorough review of safety submissions such as DSUR, PSUR, and IND-safety reporting for the combination product (biologics-device) and perform health authority submission within the allocated deadline globally

• Maintain DUNS, FEI, establishment registration for the combination product

• Collaborate with cross-functionally for annual report preparation globally

• Coordinate with external vendors to maintain registration and life-cycle of assigned products globally

• Support late-phase post-approval studies, i.e., protocol review, IND submission, maintenance, CSR review, and publication review

• Conduct a regulatory review of the medical, scientific exchange, educational material, and corporate communication for the congresses in the US 

• Proactively prioritize and complete multiple projects within the established deadline

• Maintain awareness of evolving FDA and international regulations and interpretation, competitive landscape, regulatory precedents, real-world data/evidence to support labeling expansions, etc.

We seek team members who will live by and promote the core values of our Dompé culture: integrity, speed, knowledge, passion, attention to detail, reliability, flexibility, and teamwork.  We are looking for individuals with an entrepreneurial spirit, flexible attitude, and adaptable nature to join our team.

YOU COULD BE THE PERFECT FIT IF YOU HAVE:

• 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 

• Post-approval and life-cycle management

• Previous experience with Veeva is preferred

• Strong understanding of US regulations

SKILLS YOU’LL NEED FOR SUCCESS: TECHNICAL 

• Excellent professional and regulatory writing skills

• Strong communication skills and effective cross-functional collaboration (CMC, clinical operation, supply, quality, compliance, medical affairs, clinical development, legal, HR, etc.)

• In-depth knowledge of late-stage clinical development

• Exceptional experience in post-approval submissions

• Prepare and submit high-quality regulatory submissions (coordinating with regulatory operations)

• Give direction to a cross-functional team to guarantee regulatory compliance with internal SOPs and FDA requirements, including compilation and submission of any required documents to regulatory agencies

• Maintains up-to-date knowledge of laws, regulations, and policies enforced by the FDA and provides regulatory advice accordingly

• Risk assessment and appropriate escalation to the line manager and senior leadership team.

SKILLS YOU’LL NEED FOR SUCCESS: PERSONAL

• Expertise in authoring regulatory documents

• Flexibility and use an approach based on the need and common sense to be a real problem solver.

• Commitment to thrive in a fast-paced and challenging environment and is able to balance multiple priorities effectively.

• Ability to maintain accuracy and attention to detail while meeting deadlines for assigned projects and daily activities.

• Ability to work independently, self-starter.

Base Salary: $180,000 - $235,000 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.