Director, Regulatory Affairs

Halozyme, Inc.; San Diego (CA); On-site; USD 215,000 - 230,000; Full time

Benefits offered by this job

Employee Stock Purchase Program

401(k) matching

Tuition reimbursement

Job summary

Halozyme, Inc. in San Diego seeks a Director of Regulatory Affairs to lead strategic regulatory efforts across product teams, ensuring compliant submissions and timely timelines. The role drives CMC controls, interacts with regulators, and mentors teams in a matrix setting.

You’ll guide IND/CTA/BLA submissions, collaborate with R&D, Manufacturing, and external partners, and influence regulatory strategies for clinical and commercial programs.

Qualifications

• BS/BA in a scientific discipline with 10 years in industry, or MS with 6 years experience.
• Minimum 8 years in regulatory affairs disciplines.
• At least 5 years in regulatory affairs management in biotech or pharma.
• Demonstrated leadership in developing and implementing regulatory strategy and interactions.
• Ability to prioritize and lead sophisticated projects, timelines and teams in a matrix environment.
• Creative problem solving; ability to deal with ambiguity and define a path forward.
• Track record of being results-driven and team-focused.
• Excellent written and oral communication skills.
• Experience in preparing and submitting INDs, CTAs, BLAs, MAAs, amendments, supplements.
• Knowledge of cGMPs, GCPs, and global CMC regulations; familiarity with regulators.
• RAC certification desired; strong software/tools knowledge (Veeva RIM, MasterControl, SharePoint).

Responsibilities

• Provide strategic regulatory leadership and direction for quality submissions and CMC controls.
• Guide internal and external teams for submissions to IND/CTA and BLA.
• Interact with domestic and foreign regulatory agencies and partners.
• Lead changes to supply network, including site transfers and QC transfers.
• Mentor regulatory professionals and lead cross-functional teams for timely submissions.
• Maintain up-to-date knowledge of FDA, EMA, PMDA, ICH, WHO guidelines.
• Facilitate approvals for clinical trials, marketing applications, and lifecycle amendments.
• Evaluate CMC change control records and assess regulatory impact.
• Support budget/resource planning for regulatory activities.

Skills

Regulatory leadership

Regulatory strategy

Leadership

Project management

Communication

Cross-functional collaboration

Problem solving

Regulatory interactions

IND/CTA/BL A experience

Education

BS/BA in scientific discipline

MS degree

Tools

Veeva RIM

MasterControl

SharePoint

Windows OS

MS Office Suite

Adobe

Job description

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.

Strength in diversity & collaboration Halozyme is a diverse team of innovators and problem solvers who bring their unique perspectives, backgrounds and individual life experiences to work every day. We are purposeful through our actions, working hard to cultivate a team that reflects our world and our values. Working together as one collaborative team, we can accomplish more than we ever could on our own. These ingredients are the best way to advance our mission.

How you will make an impact

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 [e-mail].

Equal Employment Opportunity Statement

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 [e-mail].