Hybrid Director, Regulatory Affairs chez None

The Director, Regulatory Affairs  has the responsibility for activities pertaining to regulatory strategy and submissions to the FDA and other Health Authorities, writting annual reports,  and manage the activities of other regulatory affairs staff or contract regulatory support in the performance of the duties outlined below.  Drug development experience in US preferred.  May manage direct report(s);   Directs through lower management levels. This position is on-site at our Rancho Cordova, CA location. 

Job Responsibilities: 

• Responsible for managing activities of Regulatory Affairs with global regulatory strategy. Preparation, review, and submission of documents to FDA and other regulatory authorities.
• In collaboration with quality and technical teams, perform/manage critical analyses of GXP related data and independently develop strategic/tactical interpretation and implementation.
• Well versed in using regulatory knowledge along with governmental requirements and regulations to obtain approvals within expected schedules.  Knowledge of how to work with various regulatory agencies is required.
• Sets strategy for submissions of product registration documents to health authorities worldwide.
• Lead and facilitate activities, including team preparation, for meetings with FDA, EMA, and other regulatory authority agencies.
• Knowledgeable of regulatory requirements of major regions (US, EU, Japan, Canada, Australia and China).
• Work with other regulatory directors across SKpharmteco's network to create regulatory strategies in assisting company's own filings, as well as and customers'.
• Interface with global regulatory authorities and consultants as needed.
• Responsible for ensuring annual documents are written and submitted to clients (i.e. annual product reviews), and regulatory agencies.
• Manage the regulatory aspect of development activities internally and with global colleagues.
• Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks.
• Oversee and ensure compliance with regulatory procedures and work practices.
• Develop and implement regulatory operating guidelines/SOPs and common work practices/strategies within the team.
• Continue to develop team knowledge base.

EDUCATION AND EXPERIENCE

• Typically requires 12 years of experience in the related area and bachelor's degree or equivalent experience. 
• 5+ years managerial experience required.
• Experience with pharmaceutical regulatory activities preferred.
• Bachelor's or Master’s degree in an appropriate science field.

COMPETENCIES/SKILLS

• Possess effective written and oral communication and interpersonal skills with ability to deal with all levels of personnel and the general public in a professional and effective manner

CERTIFICATIONS and LICENSES

• Not Applicable

This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time