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Executive Director, Regulatory and Technical Affairs

Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.
At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.
Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System?, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.
We Are Growing
Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston's Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.
A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are ? and intend to remain ? the driving vision and force behind our progress and our ultimate success.
Your Opportunity:
As a key member of our Regulatory Affairs department, the Executive Director, Regulatory and Technical Affairs is responsible in providing technical and scientific advice to the Regulatory Affairs group in support of Regulatory Strategies and submissions. The individual in this role should be able to collaborate effectively and efficiently across multiple disciplines and multiple functional groups within the company. The individual should have experience across the entire spectrum of product development and commercialization in multiple industries and experience with implantable technologies. This individual shall participate in, critically assess, and provide qualitative and quantitative input into all technical activities with a view towards development of robust regulatory registration strategies, reducing regulatory risk, promoting regulatory flexibility and minimizing post-approval submission burden. The individual will provide support for compiling and updating regulatory submissions and for regulatory inspections. In addition, he or she will represent Regulatory Affairs on various technical teams and committees.
Duties and Responsibilities:
Advise Regulatory Affairs leadership on technical matters
Gather and interpret cross-functional technical information to facilitate informed decision making
Provide technical assessment of strategies and contribute to their development
Support preparation of Regulatory submissions
Critically review submission-relevant documentation
Identify opportunities for increased regulatory flexibility
Represent Regulatory Affairs on various technical teams and committees
Process Validation committee
Provide guidance in developing regulatory strategies for process validation and data interpretation for regulatory submission.
Review validation plans, protocols, reports, and other documents to ensure compliance with current regulatory requirements and industry practices.
Inspection readiness teams
Ensure that all FDA commitments have been met and timely progress reports are provided to FDA on the remediation
Support Engineering, Quality, Process Development, Validation, and Manufacturing to trouble-shoot material, process and equipment issues, identify root causes, and implement corrective actions
Provide critical review of technical reports and documents for adherence to regulatory guidelines and requirements
Support the inspections by global regulatory agencies
Material Review Board
Evaluate investigations and provide input on their resolution and the disposition of potentially non-conforming materials.
Serve as representative on Research and Development initiatives
Provide scientific support for new initiatives such as device improvements and new formulations.
Provide technical input in process development and device performance, and contribute to preparation of documentation for regulatory submissions/inspections
Advise Regulatory Affairs and expert functions on capacity expansion initiatives, including scale up, new equipment, and new facility.
Monitor initiatives to improve existing manufacturing processes, equipment, and capabilities and provide technical assessment of potential for regulatory impact
Support continuous improvement activities, new process introductions, and provide risk assessment for regulatory strategy.
Keep abreast of all pertinent laws, regulations, guidance, industry standards, and best practices. Provide insight on current regulations and guidance documents relevant to product development projects.
Qualifications:
Advanced Degree in chemistry or engineering (graduate degree is preferred)
10 years or more in the pharmaceutical and/or medical device industry with experience in drug development and technology
Demonstrated ability to author CMC/Technical reports
Experience in preparing & critically reviewing technical reports and protocols for submission
Must have comprehensive understanding of regulatory requirements for registration, development and approval of products with a focus on combination products and medical devices specifically implant technology
Experience:
Experience with drug development and good understanding of the manufacturing and process development
Ability to establish and maintain effective working relationships
Strong analytical and interpretive skills
Critical thinking skills. Being proactive and identifying issues early along with recommending and negotiation potential solutions.
Independently accomplishing assignments with minimal supervision
Ability to work independently on projects and initiatives internally and with contract manufacturing organizations
Strong working knowledge of FDA and ICH guidelines and their application to the regulatory submissions.



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