_{20th May, 2025}

About Avance Clinical:
Avance Clinical is a Contract Research Organization offering specialized services supporting drug development for the pharmaceutical and biotechnology industry. With a rich history dating back to the 1980s, we are experts in our field and a growing organization dedicated to providing high-quality regulatory and scientific expertise. We have a great, employee-centric culture and offer excellent long-term career prospects with a focus on work/life balance. With well-established operations in Australia and in Southeast Asia, Avance Clinical is rapidly expanding its US presence, focusing on supporting our clients with IND submissions and maintenance.
Position Summary:
The Associate Director, Regulatory Affairs Operations is a key leadership role responsible for managing the US-based Regulatory Affairs Operations (RAO) team, with a primary focus on supporting Investigational New Drug (IND) application activities for our growing client base. This position requires a strong operational background in regulatory submissions, a solid understanding of FDA regulations, and the ability to provide strategic regulatory guidance. The Associate Director will potentially manage a team of Senior Specialists, Specialists and Associates and contribute significantly to Avance Clinical’s US expansion by ensuring high-quality IND submissions and building strong relationships with clients and regulatory authorities. Prior experience in regulatory strategy and a robust scientific acumen are highly valued.
Key Responsibilities:
· Leadership & Management:
o Manage, mentor, and provide guidance to Senior Specialist(s) and Specialists, RAO, US.
o Oversee the team’s day-to-day operations, ensuring timely and accurate IND preparation, submission and maintenance to safeguard regulatory compliance.
o Foster a collaborative and high-performing team environment.
o Contribute to the strategic direction of the Global RAO department.
· IND Application and Management:
o Oversee the preparation, compilation, and submission of IND applications in eCTD format to the FDA.
o Manage and address FDA requests and communications.
o Ensure regulatory compliance throughout the IND lifecycle.
o Supervise the maintenance of INDs, including amendments, annual reports, and safety updates.
o Collaborate closely with clinical operations teams to enable streamlining IND and IRB application processes.
o Identify and implement best practices for concurrent submission of INDs to the FDA and protocols/ICFs to IRBs, aiming to reduce overall timelines.
o Develop and maintain strong working relationships with key clinical operations personnel to ensure seamless integration of regulatory and clinical activities.
· Regulatory Strategy & Expertise:
o Provide strategic regulatory guidance to clients on IND-related matters.
o Stay up-to-date on FDA regulations, ICH GCP guidelines, and industry best practices.
o Evaluate and interpret regulatory guidelines and apply them to specific client projects.
· FDA Interactions:
o Support Avance’s Global Scientific and Regulatory Strategy Leads as required and participate in FDA meetings, including preparation of briefing documents and meeting logistics in support of FDA Type A-D meetings, joint FDA-EMA meetings, designation requests (expedited pathways e.g., fast-track, orphan designation) and approval pathways (e.g., accelerated approval).
o Prepare clients for FDA interactions, including pre-meeting rehearsals and Q&A preparation.
o ‘Translate’ meeting results/HA feedback in efficient regulatory operational strategy.
· Documentation & Systems:
o Ensure the accuracy and completeness of all regulatory documentation.
o Oversee the team’s use of Regulatory Information Management Systems (RIMS) to support eCTD publishing, validation, submission and application maintenance.
· Business Development Support:
o Participate in business development activities by providing regulatory expertise and contributing to proposals and fine-tuning budgetary requirements.
o Represent Avance Clinical’s regulatory capabilities to potential clients.
· Scientific Acumen:
o Utilize a strong scientific background to understand and interpret scientific data related to drug development.
o Evaluate the scientific rationale behind IND applications and provide critical input.
Qualifications:
· Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field required. Advanced degree (e.g., PharmD, PhD) preferred.
· Regulatory Affairs Certification (RAC) is highly desirable.
· Minimum of 8+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or CRO industry, with a significant focus on IND submissions and regulatory compliance.
· Demonstrated experience working collaboratively with clinical operations teams.
· Proven experience managing and mentoring regulatory affairs professionals.
· In-depth knowledge of FDA regulations, ICH GCP guidelines, and IND application requirements, including eCTD publishing and submission processes.
· Hands-on experience with RIMS.
· Prior involvement in organizing or participating in FDA meetings and experience preparing briefing documents.
· Strong understanding of US and global pharmaceutical regulatory submission strategies.
· Familiarity with FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND.
· Excellent communication, interpersonal, and presentation skills.
· Strong organizational and problem-solving skills.
· Ability to work independently and as part of a multidisciplinary team following different matrix modalities as determined by Sponsor capabilities and contractual agreements.