Director of Regulatory Affairs- Drug Device Combination Products

Company: La Cresta Life Sciences (Recruitment Agency)

Position: Director of Regulatory- Drug Device Combo Products

Location: Orange County

Posted: June 16, 2024

We are seeking an experienced Director of Regulatory Affairs to join our team a growing team in Orange County, CA focused on best in "best in class" ophthalmic drug-device combo products. This position has the responsibility for supporting the VP, Regulatory Affairs in developing and implementing global regulatory strategy, primarily on drug-device combination products, or prescription pharmaceuticals in the US, EU, and international markets. They will also be responsible for addressing and resolving regulatory issues in preclinical, CMC, clinical and commercial development programs. The position interacts with all levels in the organization, participating in discussions with management and providing strategic regulatory guidance. The role is hybrid and open to relocation for the right candidate.

Essential Duties & Responsibilities:

  • Support the VP, Regulatory Affairs to develop and implement global regulatory strategies, primarily on drug-device combination products or prescription pharmaceuticals.
  • Provide strategic regulatory guidance to interdisciplinary project teams, aligning with FDA/MOH regulatory requirements, FDA/ICH guidelines, and industry best practices.
  • Proactively identify regulatory, quality, and technical issues and recommend / implement solutions to resolve them.
  • Participate in FDA and HA meetings, including FDA Pre-IND, EOP2, EOP3, Pre-NDA, Type C/D meetings, Pre-Sub meetings, EMA Scientific Advisory meetings.
  • Prepare and review of regulatory submissions, including clinical trial applications, IND,  meeting packages for FDA, EMA, technical files/design dossier and other regulatory agencies.
  • Manage and facilitate submission deliverables and follow-up with team members, ensuring that all applications are filed in accordance with predetermined timelines.
  • Collaborate closely with cross-functional teams, including R&D, Clinical Operations, Quality Assurance, and Clinical teams, to ensure regulatory compliance and successful product development.
  • Interact and coordinate with R&D staff (CMC and Engineering) and consultants to ensure compliance to applicable Design Control and pharmaceutical requirements (for drug/device combination products).
  • Stay abreast of regulatory trends, changes, and requirements in the pharmaceutical industry, providing strategic guidance and recommendations to senior management on regulatory matters.


Qualifications Required For Position:

  • Bachelor's degree in a relevant scientific discipline; advanced degree (e.g., Master's preferred.)
  • Minimum of 10 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on drug and drug/device combination products.
  • In-depth knowledge of US, EU, and international regulatory requirements and guidelines for drug and drug/device combination products, including FDA/MOH regulations and FDA/ICH guidelines. Experience in preparing and filing US IND/amendments, annual reports, and briefing books.
  • Knowledge of pharmaceutical development and CMC requirements for INDs.
  • Thorough understanding of the CFR, FDA/ICH guidelines, GxP and cGMP as they pertain to pharmaceutical development and manufacturing.
  • Knowledge of design controls, device development (Class III) and drug-device combination product development a plus.
  • Knowledge of regulatory CMC and product development requirements at various stages of development.
  • Proven track record of successful regulatory submissions, meetings, and interactions with regulatory agencies.
  • Strong leadership, communication, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
  • Experience in regulatory strategy development, regulatory compliance, and leading regulatory activities for sustained release drug and drug/device combination products.
  • Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously while maintaining attention to detail and quality.