Director, Regulatory Affairs

Halozyme • San Diego, CA

1d

About The Position

The Director, Regulatory Affairs leads the co-development and implementation of global regulatory strategies for marketed and development products. The role leads regulatory activities for internal and external programs and works with cross-functional subject matter experts to ensure effective partnerships, execution of regulatory strategies and requirements, and timely submission and approval of global regulatory filings for external collaboration partners. The Director is expected to demonstrate organizational leadership and influence the future direction of Halozyme Therapeutics and its partners.

The position provides strategic regulatory leadership for product teams and partner programs, particularly for chemistry, manufacturing, and controls (CMC) sections supporting IND/CTA and BLA submissions. It serves as a liaison among the company, partners, and regulatory authorities; guides regulatory risk mitigation; supports regulatory agency interactions and meetings; and leads cross-functional preparation of submissions and responses. The Director also evaluates CMC change-control records, supports change implementation and resource planning, and supervises, mentors, trains, and develops regulatory professionals. The role collaborates with R&D, Product Development, Manufacturing, Quality, Preclinical Development, CDMOs, and external partner experts.

Requirements

• BS/BA in a scientific discipline with 10 years of industry experience, or a master’s degree with 6 years of experience; an equivalent combination of education and experience will be considered.
• At least 8 years of experience in regulatory affairs disciplines.
• At least 5 years of regulatory affairs management experience in a biotechnology or pharmaceutical company involved in developing, manufacturing, testing, and distributing ethical pharmaceutical or biotechnology products.
• Demonstrated leadership in developing and implementing regulatory strategy and experience with regulatory interactions.
• Ability to prioritize and lead sophisticated projects, timelines, and teams in a matrix environment.
• Creative problem-solving ability, including handling ambiguity and conducting research to define a clear path forward.
• Demonstrated results-driven track record.
• Strong leadership skills, including working through a team to prioritize and drive achievements.
• Strong oral and excellent written communication skills.
• Ability to prioritize and work on multiple projects simultaneously.
• Strong business acumen and ability to balance business and staff development needs.
• Experience preparing and submitting INDs, CTAs, BLAs, MAAs, annual reports, amendments, and/or supplements.
• Knowledge of cGMPs, GCPs, and global CMC regulations pertaining to development, manufacturing, and distribution of biologics or drugs; familiarity with global regulatory guidelines and standards; and significant experience dealing with regulatory authorities.
• Knowledge of Windows OS, MS Office Suite (Outlook, Word, Excel), Adobe, Veeva RIM, MasterControl, SharePoint, or similar listed software.

Nice To Haves

• Familiarity with regulatory aspects of combination drugs/devices.
• Industry certification such as Regulatory Affairs Certification (e.g., RAC-Drugs).

Responsibilities

• Provide strategic regulatory leadership and direction to product teams on regulatory requirements for quality submissions, CMC controls, and program timelines.
• Guide internal project teams and external collaboration partners on CMC sections for IND/CTA and BLA submissions.
• Communicate with domestic and foreign regulatory agencies and interact directly with regulatory authorities.
• Lead and mentor major supply-network changes, including technical transfers between sites, QC transfers, new product development, and implementation of comparability protocols.
• Serve as a liaison among the company, partners, and regulatory authorities on regulatory issues.
• Advise on tactics and strategies to mitigate regulatory risks.
• Lead regulatory partnership programs to achieve clinical and commercial regulatory strategies.
• Maintain current knowledge of relevant FDA, EMA, PMDA, ICH, WHO, and other applicable guidelines and regulations.
• Facilitate timely regulatory approvals for partners’ clinical trial applications, marketing applications, and post-approval lifecycle amendments and supplements by ensuring submission quality and appropriateness.
• Lead cross-functional teams in preparing high-quality regulatory submissions and responses to agency inquiries, including CMC sections for initial applications, amendments, supplements, and response documents.
• Evaluate CMC change-control records, assess regulatory impact, and support change implementation.
• Support budget and resource planning for regulatory activities as needed.
• Supervise, mentor, train, and develop regulatory professionals supporting assigned programs.
• Identify priorities and key issues in complex situations and solve problems with minimal assistance.
• Prepare and plan for regulatory agency meetings.
• Work with external partners to develop strategies, provide regulatory support, and prepare high-quality submissions on time.
• Collaborate with R&D, Product Development, Manufacturing, Quality, Preclinical Development, CDMOs, and experts in external partner organizations.
• Identify information and process gaps and develop solutions to fill or mitigate them.
• Perform other duties as assigned.

Benefits

• Comprehensive benefits program, including an Employee Stock Purchase Program and 401(k) matching.
• In-house learning and development programs and tuition reimbursement.
• Collaborative and innovative team environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Director