Director/Associate Director Regulatory Affairs Anacor Pharmaceuticals, Inc.

Job Summary

The Regulatory Affairs Director will be leading a team responsible for the successful preparation and submission of an electronic NDA for Anacors lead candidate. The role also involves providing regulatory expertise and operational guidance to cross functional teams throughout the drug development process. The Regulatory Affairs Director will be also responsible for maintaining collaborative relations and efficient communications with FDA and other health authorities during the regulatory submission and approval processes of Anacor programs. This position will report to the VP of Regulatory Affairs and Quality.
Job Responsibilities

Support VP of RA/QA in building a team, including working with the selected vendor, for an electronic NDA submission of Anacors anti-fungal drug product
Provide regulatory guidance to company personnel in preparation for the NDA and key regulatory documents for other Anacor drug products and be responsible for ensuring that all state and federal regulatory requirements are met.
Represent the regulatory affairs during FDA discussions and actively participate and analyze regulatory correspondence and coordinates follow-up discussion with internal colleagues and external parties to ensure all regulatory request and commitments are met with accuracy and in a timely fashion.
Identify and assess regulatory risks associated with CMC and Clinical sections of the NDA. Define strategies to mitigate those risks and works with the teams to implement them.
Ensure that all adverse events are dealt with in accordance with company SOPs and FDA regulations and ICH guidances.
Direct the organization and preparation of complete and effective submissions for all Anacor drug products.
Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development. Prepare and deliver effective presentations for external and internal audiences as needed.
Form informal networks with program managers, and functional leaders to discuss regulatory developments.
Ensure that the interfaces between Regulatory and other departments are managed optimally.
In colaboration with program management develop strategic plans whereby both new chemical entities and existing products are considered by Regulatory, Clinical, Marketing and Finance departments through cross-functional teams, to ensure program timelines are met.
Ensure effective team communication throughout the Regulatory and Quality department and provide coaching to the regulatory group in various aspects of regulatory sciences.

Job Requirements

The successful candidate for this Regulatory Affairs Director position will have the following qualifications, experience and skills:

B.S. in life sciences required.
Proven knowledge and experience in the preparation of major regulatory submissions (INDs, NDAs, CTAs)) and amendments for New Molecular Entities (NMEs).
Prior experience on NDA preparation and submission using eCTD format and applicable tools is a must.
At least 10 years of regulatory experience and a strong understanding of US regulations and FDA review processes.
Ability to foster effective, positive interactions with regulatory agencies.
Ability to lead and influence project teams, committees, etc. to attain group goals. Demonstrate excellent leadership and people management skills.
Strong interpersonal skills and ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff in a multicultural/ multinational environment.
Highly organized, detail oriented, effective written and oral communication skills. Highly proficient in the use of Word, Excell and Power Point.
Prior supervisory experience is desirable.
Experience in the Dermatology therapeutic area highly desirable.

Location:	Palo Alto, CA United States