Director, Regulatory Affairs

Halozyme, Inc.•San Diego, CA

2d•$215,000 - $230,000

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 execute regulatory strategies and requirements, and to support timely global regulatory filings and approvals for external collaboration partners. The director is expected to provide 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 regarding quality submissions and chemistry, manufacturing, and controls (CMC) requirements. It supports regulatory interactions, supply-network changes, clinical and commercial regulatory strategies, and preparation of submissions and agency responses. The director also mentors regulatory professionals, supports resource planning, and works across Halozyme departments, contract development and manufacturing organizations, and partner organizations.

Requirements

BS/BA in a scientific discipline with 10 years of industry experience, an MS degree with 6 years of experience, or an equivalent combination of education and experience.
At least 8 years of experience in regulatory affairs disciplines.
At least 5 years of regulatory affairs management experience in a biotech or pharmaceutical company involved in the development, manufacture, testing, and distribution of 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 skills, ability to handle ambiguity, and ability to research and define a clear path forward.
Demonstrated results-driven track record.
Strong leadership skills, including working through a team to prioritize and drive achievement.
Strong oral and excellent written communication skills.
Ability to prioritize and manage 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 for development, manufacturing, and distribution of biologics or drugs; familiarity with global regulatory guidelines and standards; and significant experience dealing with regulatory authorities.
Software knowledge including Windows OS, MS Office Suite (Outlook, Word, Excel), Adobe, Veeva RIM, MasterControl, and SharePoint.

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, appropriate CMC controls, and program timelines.
Guide internal project teams and external partners on CMC sections for IND/CTA and BLA submissions.
Communicate with domestic and foreign regulatory agencies and interact directly with regulatory agencies.
Lead and mentor major supply-network changes, including technical transfers, QC transfers, new product development, and strategic comparability protocols.
Serve as a liaison among the company, partners, and regulatory authorities on regulatory issues.
Advise on tactics and strategies for mitigating 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 partner regulatory approvals for 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 partner CMC sections for 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 meetings with regulatory agencies.
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 at external partner organizations.
Identify and assess gaps in information or processes and develop solutions to fill or mitigate them.
Perform other duties as assigned.