Associate Director Regulatory Affairs
Associate Director Regulatory Affairs
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Associate Director Regulatory Affairs
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 an Associate 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 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 of regulatory strategy.
In this role youll 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 sitetosite 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 youll 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 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 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 $158k $221k 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
