Director, Regulatory Affairs

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Welcome to an inspired career.

At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team – we rise by lifting others up and believe in the power of working together for the collective win. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.

Join us as a Director, Regulatory Affairs, and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives.

How you will make an impact

The Director, Regulatory Affairs leads in the co-development and implementation of global regulatory strategies for marketed and development products. They lead regulatory activities for internal and external programs and work closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of global regulatory filings for external collaboration Partners. The role is expected to exhibit strong organizational leadership and values while influencing the future direction of Halozyme Therapeutics and its partners.

In this role, you’ll have the opportunity to:

• Provide strategic regulatory leadership and direction to product teams addressing the regulatory requirements for quality submissions, clarifying requirements for appropriate CMC controls, and maintaining forecasted timelines in support of the overall programs
• Provide strategic regulatory leadership and guidance to internal project teams and external collaboration Partner teams for chemistry, manufacturing, and controls (CMC) sections intended to support IND/CTA and BLA submissions.
• Interacts with multiple partners communicating with domestic and foreign regulatory agencies and directly with regulatory agencies
• Provide leadership and mentorship for major changes to the supply network, including but not limited to: site-to-site technical transfers, QC transfers, new product development and implementing comparability protocols on a strategic basis
• Serve as a liaison among the company, partners, and regulatory authorities on regulatory issues
• Advise on the tactics and strategies for mitigating regulatory risks
• Lead regulatory partnership programs to ensure overall clinical and commercial regulatory strategy is achieved
• Maintain up-to-date knowledge and expertise 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 life-cycle management amendments/supplements by ensuring the quality and appropriateness of submissions
• Lead cross-functional teams for timely preparation of high-quality regulatory submissions and responses to inquiries including CMC sections for partners’ initial applications, amendments/supplements, and response documents for regulatory agencies
• Evaluate chemistry, manufacturing, and controls (CMC) change control records, assess regulatory impact, and support change implementation
• Support budget and resource planning initiatives for regulatory activities as needed
• Supervise, mentor, train and develop regulatory professionals supporting the assigned program(s) in a manner that blends the organizational needs with their developmental needs.
• Identifies priorities and key issues in complex situations and solves these problems with minimal assistance
• Provides preparation and planning support for meetings with regulatory agencies
• Routinely interacts with Halozyme external partners to assure timely development of strategies, deliver required regulatory support and craft high-quality submissions
• Work closely with the R&D, Product Development, Manufacturing, Quality, and Preclinical Development departments, Contract Development and Manufacturing Organizations (CDMOs), and experts in Halozyme external partners’ organizations
• Acknowledge and assess gaps in information, process as they arise, and develop solutions to fill/mitigate those gaps
• Other duties as assigned

To succeed in this role, you’ll need:

• BS/BA in a scientific discipline with 10 years of industry experience, or MS degree with 6 years’ experience, or equivalent combination of education/experience will be considered.
• A minimum of 8 years in regulatory affairs disciplines
• At least 5 years’ experience in a regulatory affairs management position in a biotech or pharmaceutical company involved in the development, manufacture, testing and distribution of ethical pharmaceutical products or biotechnology products
• Demonstrated leadership in developing and implementing regulatory strategy and experience in regulatory interactions
• Ability to prioritize and lead sophisticated projects, timelines and teams in a matrix team environment
• Creative approach to problem solving; ability to deal with ambiguity and perform the necessary research to define a clear path forward
• Demonstrated track record of being results driven
• Strong leader who works through the team to prioritize and drive achievements
• Strong oral and excellent written communication skills
• Energetic person with ability to prioritize and work on multiple projects at the same time
• Strong business acumen, with the ability to balance business and staff development needs
• Experience in the preparation and submission of: INDs, CTAs, BLAs, MAAs, Annual Reports, Amendments, and/or Supplements
• Familiarity with regulatory aspects combination drugs/devices desired
• Knowledge of cGMPs, GCPs, and global CMC regulations pertaining to the development, manufacturing and distribution of biologics or drugs; familiarity with global regulatory guidelines and standards; significant experience dealing with regulatory authorities
• Industry certification such as Regulatory Affairs Certification (e.g., RAC-Drugs) desired
• Software Knowledge: Windows OS, MS Office Suite (Outlook, Word, Excel), Adobe, Veeva RIM, MasterControl, SharePoint, etc.

In return, we offer you:

• Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.
• A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.

The most likely base pay range for this position is $215K - $230K per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.

Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Accessibility and Reasonable Accommodations:

Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at [email protected].

To view all our open positions, please visit our career page. Additionally, our benefit offerings can be found here