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Associate Director/Director, Regulatory Affairs - SM001 Relypsa
DEPARTMENT: Regulatory AffairsRelypsa will soon be located in Redwood City and we are hiring! Relypsa is seeking a reliable, self-motivated professional for the position of Associate Director/Director, Regulatory Affairs. This position will support Regulatory Affairs in the management of clinical and nonclinical regulatory activities and submissions to FDA and other health authorities for investigational and marketed products.
PRIMARY RESPONSIBILITIES:
Lead regulatory activities, including planning and reviewing of clinical and nonclinical sections of regulatory submissions for content and format. Develop and manage regulatory submission project timelines for assigned projects
Prepare, review and finalize IND/CTA submissions (initial and amendments) and annual reports for the company?s polymer drugs, which are consistent with applicable regulations and guidelines
Review submitted data and documentation for accuracy and completeness and ensure information is within the goals of the submission
Ensure documentation is well organized, clear, comprehensive and within the countries? regulations and guidelines governing the submission
Coordinate internal review and signoff, adjudicate comments and finalize submission documents
Lead the effort to request and obtain Scientific Advice from EMA prior to NDA submission
Contribute to the development, review, management and submission of an NDA for lead polymer product and potentially assist with the electronic submission aspects of the NDA
Coordinate and prepare company responses to information requests from regulatory authorities
Assist in the regulatory review of clinical study documents (e.g., protocols, ICFs, IB, safety reports/narratives, and study labels) and nonclinical documentation (e.g., study protocols and reports)
Contribute to pre-launch activities, such as review and approval of advertising and commercial documents, and preparation, review and finalization of post-approval submissions
Participate in project team meetings and provide regulatory guidance and leadership
Assist in evaluating and disseminating information about emerging and new regulations and guidelines that may affect Relypsa products, and conduct regulatory research on competitor activity and positioning
SKILLS/EXPERIENCE:
Must have demonstrated experience in filing INDs, CTAs, NDAs and MAAs and post-approval submissions
Must have experience with obtaining EMA Scientific Advice
Strong knowledge of FDA/ICH regulations and guidelines, particularly clinical and nonclinical, and GXPs
Experience with review of advertising and commercial documents
Manages (initiates, directs and completes) defined projects within agreed-upon parameters and timelines
Ability to work under pressure and meet tight timelines while maintaining attention to detail and accuracy
Experience with eCTDs is a plus
Proficiency in Microsoft Word, Excel, PowerPoint and Adobe Acrobat. Experience with MS Project is a plus
QUALIFICATIONS:
BS or higher degree in science or law, or equivalent, with 7+ years? experience in research and/or industry including at least 5 years in regulatory affairs
Must have excellent organizational and problem solving skills
Good interpersonal skills, ability to work with, influence, and manage people from diverse backgrounds and various management levels
Energetic, ?roll-up sleeves? attitude which is especially important in a small but growing organization
NOTE: This job description is not intended to be all-inclusive. Other related duties as negotiated may be assigned to meet the ongoing needs of the organization.
As an employee of Relypsa, you will actively contribute to the development of potential new products. Our small company culture provides opportunity for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs including pre-IPO stock options reflect Relypsa?s high regard for our employees. EOE
| Location: | 5301 Patrick Henry Drive Santa Clara, CA 95054 United States |
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Relypsa
All Jobs: at Relypsa| Web Site: | www.relypsa.com |
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| Headquarters: | 5301 Patrick Henry Drive Santa Clara, CA 95054 United States |
| Industry: | Biotechnology |
