Director Regulatory Affairs
Director Regulatory Affairs
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Job Description
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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. Thats why we need youto 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 youll be part of a culture that welcomes diversity thinks differently to solve problems works collaboratively as one team and delivers meaningful innovations that impact peoples lives.
How you will make an impact
The Director Regulatory Affairs leads the codevelopment and implementation of global regulatory strategies for marketed and development products. They lead regulatory activities for internal and external programs and work closely with crossfunctional subject matter experts to ensure an effective partnership and of regulatory strategy regulatory requirements and the timely submission and approval of global regulatory filings for external collaboration Partners.
In this role youll 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 sitetosite 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 uptodate knowledge and expertise of relevant FDA EMA PMDA ICH ISO and other applicable guidelines and regulations
Facilitate timely regulatory approvals for partners new devices and lifecycle activities by ensuring the quality and appropriateness of submissions
Lead crossfunctional teams for timely preparation of highquality 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 highquality submissions
To succeed in this role youll 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 /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 exUS regulations pertaining to the development manufacturing and distribution of biologics or 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 inhouse programs and tuition reimbursement.
A collaborative innovative team that works as one to amplify your impacton 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 individuals 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 .
To view all our open positions please visit our career page. Additionally our benefit offerings can be found here.
Required Experience:
Director
Employment Type
Full-Time
