The Director/Associate Director, US Regulatory Affairs & Global Development Projects (GDP) is responsible for providing strategic leadership and oversight of all U.S. regulatory activities for assigned products. This role is responsible for ensuring compliance with FDA regulations and guidelines driving regulatory strategies and facilitating successful interactions with regulatory authorities. Additionally, this role provides strategic regulatory guidance and support to our global programs, with a specific focus on US regulatory requirements.

　　The Director/Associate Director, US Regulatory Affairs & Global Development Projects is responsible for developing and executing robust regulatory strategies that align with the overall business objectives, ensuring compliance with FDA regulations and optimizing the regulatory pathway for product approvals and launches. This role oversees the preparation, review, and submission of regulatory filings to the FDA, including INDs, NDAs, BLAs and other relevant submissions. Ensures accuracy, completeness, and timeliness of submissions to facilitate regulatory approvals. Establishes and maintains processes and systems to ensure ongoing compliance with FDA regulations, guidelines, and requirements. Collaborates with cross-functional and regional teams to drive adherence to regulatory requirements throughout the product lifecycle. Serves as primary point of contact and liaison with FDA representatives and other regulatory authorities. Facilities regulatory agency meetings, addressing inquiries, and leading interactions to ensure effective communication and collaboration. Partners closely with R&D, Clinical, Quality and Manufacturing colleagues to provide regulatory guidance and ensure alignment of regulatory strategies with business goals and objectives. Prepares and coordinates for regulatory inspections and audits. Develops and implements strategies to address findings and ensure timely resolution of any compliance issues. Lastly, this role is responsible for building and maintaining a high-performing regulatory affairs team providing mentorship, coaching, and professional development opportunities to team members. Fosters a collaborative and growth minded culture to support success of team.

　　RESPONSIBILITIES

　　The following job duties are not all-inclusive and additional responsibilities may be added to the role as needed. The duties and responsibilities listed are intended to provide a general overview of the position and may change over time based on the needs of the organization.

　　Direct and coordinate activities of assigned products within Regulatory Affairs encompassing developmental products and post-marketing commitments.

　　Function as the primary contact for negotiations and interactions with the FDA and offer guidance and strategy to ex-US strategy and filings.

　　Contribute to developing regulatory strategies to ensure the shortest FDA review and approval times for regulatory applications.

　　Provide regulatory guidance to team during the course of strategy formulation and submission preparation.

　　Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Ensure consistency, completeness, and adherence to FDA standards for all regulatory submissions.

　　Author (when applicable) and maintain IND and NDA applications, supplements and annual reports pertaining to on-going application maintenance in accordance with established timelines and submission dates.

　　Liaison with regulatory agencies on product-related regulatory issues. Schedule, participate in, and prepare briefing documents for face-to-face meetings and teleconferences with health authorities.

　　Critically review protocols, data and reports to ensure the clarity, consistency, and conformance to regulations, guidelines and regulatory strategy as well as suitability for submission to regulatory agencies.

　　Assist with departmental policy and procedure development and implementation. Ensure adherence to Company Standard Operating Procedures. Review and assess Companys change controls with respect to regulatory requirements.

　　Prepare and submit reports to senior management, as required.

　　Offer regulatory evaluation and opinions on due diligence activities and provide regulatory assessment to management.

　　Other duties as assigned.

　　SUPERVISORY | DECISION-MAKING AUTHORITY

　　This position will manage direct reports.

　　MINIMUM JOB REQUIREMENTS

　　Bachelors degree in a scientific discipline (advanced degree preferred).

　　Minimum of 8 years experience or 7 years experience to qualify for the Director or Associate Director level respectively in US Regulatory Affairs within the pharmaceutical or biotechnology industry. Direct CDER experience preferred. RAC certification preferred.

　　Possess a deep understanding of FDA/ICH regulations, guidelines, and regulatory processes across various product types (i.e .drugs, biologics) and ex-US requirements ensuring ongoing compliance with FDA/ICH regulations, guidelines and current Good Manufacturing Processes (cGMP).

　　Adept at establishing processes and systems to drive regulatory requirements throughout the lifecycle.

　　Demonstrated proficiency in preparing, reviewing, and submitting regulatory filings to the FDA, including INDs, NDAs, BLAs, and other relevant submissions ensuring accuracy, completeness, and timeliness of submissions.

　　Exhibit strong capabilities in managing interactions with regulatory authorities, including leading meetings, addressing inquiries, and facilitating communication and collaboration.

　　Possess strong project management skills to prioritize and manage multiple projects simultaneously, while meeting deadlines. Coordinating regulatory...

　　Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity