Associate Director, Regulatory Affairs

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Associate 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 an Associate 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 Associate Director, Regulatory Affairs leads and manages the development and implementation of global regulatory Nonclinical, Clinical, and CMC strategies for company and partner products. This role involves strategic planning, preparation, and timely submission of regulatory documents to ensure compliance with global regulatory requirements and works closely with cross functional subject matter experts to ensure an effective partnership and execution of regulatory strategy.

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

• Provide leadership and direction to Halozyme teams addressing the regulatory requirements for nonclinical, clinical and CMC submissions, maintaining forecasted timelines in support of the overall programs.

• Develop and implement regulatory CMC strategies for new and existing products, ensuring alignment with overall regulatory and business objectives.

• Provide strategy and direction to product teams addressing the regulatory requirements for quality submissions, clarifying manufacturing requirements for appropriate CMC controls, and maintaining forecasted timelines in support of the overall programs

• 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

• Work closely with the R&D, Product Development, Manufacturing, Preclinical Development departments and with Contract Manufacturing Organizations and Halozyme alliance partners.

• Review and ensure the accuracy and completeness of regulatory documents, including INDs, BLAs/NDAs, MAAs, and responses to health authority queries.

• Stay updated with current regulatory requirements and guidelines, providing regulatory advice to technical subject matter experts.

• Acknowledge and assess gaps in information and processes as they arise and develop solutions to fill/mitigate those gaps

To succeed in this role, you'll need:

• BS/BA/MS in a relevant scientific field with minimum of 10 years of experience in Regulatory Affairs, with a focus on CMC in the biotech or pharmaceutical industry (an equivalent combination of education, e.g., an advanced degree and experience may be considered).

• Strong knowledge of global regulatory requirements, excellent written and verbal communication skills, and the ability to manage multiple projects and deadlines.

• Balanced knowledge of foreign and domestic regulations pertaining to the development, manufacturing and distribution of biologics or drugs to be able to support partner development efforts and implementing global regulatory strategies

• Ability to prioritize and lead sophisticated projects, timelines and teams in a matrix team environment

• Experience with biologics and/or combination products.

• Proven track record of successful regulatory submissions, approvals, and health authority interactions.

• Strong leadership and team management skills.

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 $158k - $221k 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.