Main Purpose of Position:

The VP Regulatory Affairs sets the regulatory strategy for all of DURECT's development programs in the US and worldwide. The VP Regulatory Affairs will have overall responsibility for the areas of Regulatory Affairs and as such will represent DURECT in all of DURECT's interactions with Health Regulatory Authorities in the US and worldwide.

Main Duties and Responsibilities:

• Responsible for developing and implementing the regulatory planning strategy for each product, as well as provide extensive strategic planning for regulatory issues related to drug development at all stages, including pivotal study design, to secure licensure.
• Serves as DURECT's representative with FDA and/or other Agencies and will be responsible for strategic planning; development, preparation, and review of Chemistry, Manufacturing, and Controls (CMC) sections and related regulatory agency interactions.
• Overall responsibility for preparation and management of marketing authorization applications (MAAs) and new drug applications (NDAs) and their maintenance.
• Review and sign-off of all DURECT's regulatory submissions, review such submissions prepared by direct reports that are junior level personnel.
• Guides regulatory team to define and develop efficient internal systems for sharing and archival of strategic documents such as guidance and training programs; provides staff development as needed which includes hiring and supervises of direct reports and mentoring of junior staff members.

• Ph.D. Degree in Biomedical Science or an M.D. degree, optimal with at least 14 years of experience, including leading role in Regulatory Affairs Department of a pharmaceutical company engaged in drug development.
• Relevant experience in filing and maintaining regulatory submissions such as INDs, full CTDs/NDAs, marketing authorization applications (MAAs) and new drug applications (NDAs), supplements, meeting requests and other correspondences with FDA and other health authorities. Has substantial hands-on experience in heading a team preparing and submitting these documents.
• Relevant experience in comprehensive preclinical development to support first-in-man studies- specifying studies needed in preclinical phase needed to move product through clinical development to global registration.
• Prior tenure within US and/or European Health Regulatory Authorities preferred.
• Possess excellent leadership and mentoring qualities, good interpersonal skills and inspire in his or her reports the willingness to accept responsibility, the ability to exert technical judgment, attention to detail, and desire to work independently that signifies successful teams.
• Excellent contacts with key staff within US and/or European Health Regulatory Authorities.
• Strong strategic/analytical skills to map out optimal pathways to regulatory approvals for DURECT's compound candidates.
• Ability to anticipate regulatory hurdles, health authorities concerns or changes in the regulatory environment.
• Operating skills heading Regulatory Department in pharmaceutical company.
• Strong oral and written communication skills.
• Ability to set goals, build accountability and to follow-through.
• Proactive, energetic, flexible, hardworking and focused.
• Promotes positive work environment and sets highest standards for business ethics and integrity.

Working Conditions:

• 100% of work is performed in a typical office environment.
• No or very limited exposure to physical risk.
• Light physical effort - some standing and walking.
• Ability to travel both in and out of the United States.

IMPORTANT: In the subject line of your email please include your SURNAME, FIRSTNAME, followed by 540Oct08_PL (copy and paste). Your submission MUST contain this exact job-number, NOT THE JOB TITLE, in order to be properly routed and considered. 

DURECT Corporation is an Equal Opportunity Employer

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