Director, Regulatory Affairs

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Director, Regulatory Affairs- This position can be based either in our San Diego, CA or Minnetonka, MN location.

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 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.

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 project teams and design programs for device sections of Device Master Access Files, Technical Files, and Device and Combination Product Design History Files, intended to support IND/CTA submissions, and NDA and ANDA submissions.

• Provide leadership and mentorship for major changes to the supply network, including, site-to-site technical transfers, QC transfers, new product development and implementing comparability protocols on a strategic basis

• 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, ISO and other applicable guidelines and regulations

• Facilitate timely regulatory approvals for partners' new drugs, devices and life-cycle activities 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/MAF sections for partners' initial applications, amendments/supplements, and response documents for regulatory agencies

• Evaluate manufacturing, device analytical change controls, assess regulatory impact, and support their implementation

• Lead and manage budget and resource planning initiatives for regulatory activities

• Supervise, mentor, train and develop regulatory professionals supporting the assigned program(s) in a manner that blends the organizational needs with their developmental needs.

• Routinely interacts with Halozyme alliance partners to assure timely development of strategies, deliver required regulatory support and craft high-quality submissions

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 (equivalent combination of education/experience will be considered).

• A minimum of 8 yearsin regulatory affairs disciplines, and 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

• Experience in the preparation and submission of: INDs, CTAs, BLAs, MAAs, 510(k)s, PMAs, CE Conformity Technical Files, Annual Reports, Amendments, Supplements and MDRs, Design History Files, Technical Files and MAFs

• Familiarity with all aspects of Design Controls (Device Design) including the processes of design input through validation/verification for small mechanical devices, as well as combination drugs/devices

• Knowledge of cGMPs, GCPs, ISO/CE Mark requirements; familiarity with global regulatory guidelines; significant experience dealing with regulatory authorities

• Industry certification, such as Regulatory Affairs Certified (RAC) desired

• Knowledge of ex-US regulations pertaining to the development, manufacturing and distribution of biologics or drugs is helpful

• Software Knowledge: Windows, MS Office (Outlook, Word, Excel), Adobe, eCTD viewer, 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 $180K - $252K 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.

AccessibilityandReasonableAccommodations:
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 hrbox@halozyme.com.

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