Director Regulatory Affairs Anacor Pharmaceuticals, Inc.
Reporting to the VP of Regulatory Affairs and Quality, the Regulatory Affairs Director will be a key senior contributor and leader on a team responsible for providing regulatory guidance to cross functional teams and for the successful preparation and submission of regulatory documents for Anacor?s drug candidates to the Agency.
Represent regulatory affairs during FDA discussions.
Analyze regulatory correspondence, develop responses in collaboration with internal and external parties, and ensure all regulatory requests and commitments are met with accuracy and timeliness.
Provide regulatory guidance to multifunctional development teams to ensure Anacor programs comply with all state and federal regulatory requirements.
Develop regulatory strategies to reduce regulatory risks associated with Clinical, CMC and nonclinical sections of an NDA; work with respective teams to implement them.
Ensure that all safety aspects of drug development are dealt with in accordance with company SOPs, FDA regulations and ICH guidance.
Direct the organization and preparation of complete and effective regulatory submissions for all Anacor products, including future NDAs.
Provide leadership on project teams in all areas of regulatory affairs and product development. Prepare and deliver effective presentations for external and internal audiences as needed.
Ensure that the interfaces between Regulatory and other departments are managed optimally.
Develop regulatory strategies for Anacor programs whereby regulatory requirements are considered by Clinical, Pharmaceutical Development, Non Clinical and Finance departments as well as program and business needs.
Ensure effective communications throughout the Regulatory and Quality department and provide coaching to the regulatory group in various aspects of regulatory sciences.
BS/MS in life sciences required; advanced degree a plus
10 (+/- 3) years of pharmaceutical regulatory experience in leadership roles
Strong understanding of US FDA regulations and review processes
Proven knowledge and experience in the preparation of major regulatory submissions (INDs, NDAs, and CTAs)) for New Molecular Entities (NMEs)
Prior experience with preparation of electronic submissions and applicable tools
Proven ability to foster effective, positive interactions with regulatory agencies
Ability to lead and influence matrix project teams, external experts and vendors to attain goals; demonstrated excellent leadership and people management skills
Strong interpersonal skills and ability to deal effectively with a variety of scientific personnel in a cross functional and diverse environment.
Highly organized, detail oriented. Must have effective written and oral communication skills and be highly proficient in the use of Word, Excel, Power Point, Microsoft Project and other desktop software applications.
Experience in the dermatology therapeutic area highly desirable.
||Palo Alto, CA |