Head of Reg. Affairs & QA Ambit Biosciences
Department: Regulatory Affairs
Job Title: Head of Reg. Affairs & QA
Job Location: San Diego, CA
The Head of Regulatory Affairs and Quality Assurance will be responsible for leading and directing all regulatory and quality activities for Ambit Biosciences. They will work collaboratively with the Senior and Executive Management Teams in all of the Company?s development programs. They will also be responsible for developing regulatory and quality strategies for the company.
Essential Job Functions:
?Provides primary leadership to the regulatory affairs and quality assurance group, creating a culture that models a proactive, creative but considered approach to addressing regulatory needs.
?Provides regulatory and quality leadership and input to enhance the strategy and design of clinical development programs for the company?s product development candidates.
?Assumes ownership and accountability for the timely preparation and coordination of all regulatory submissions and communications as well as ensuring that all quality systems are in compliance with regulations.
?Ensures that all contacts with regulatory authorities are conducted to the highest professional standard building a reputation of quality, responsibility, and trust for the company.
?Establishes and maintains a strong, regulatory affairs and quality assurance vision and culture that is consistent with, and supports, the overall strategy and culture of the company.
?Effectively communicates the regulatory strengths and risks associated with all of the company?s products and development candidates to the other members of senior management.
?Maintains primary responsibility for the day-to-day operations of the regulatory affairs and quality assurance group.
?Effectively utilizes third party contractors, consultants, and vendors in the execution of regulatory affairs and quality assurance activities as required.
?Provides due diligence support in the evaluation of all product acquisition candidates.
?Directs collaborative interactions with industry partners as appropriate.
?Actively participates in the development of the company culture.
?Demonstrates managerial success via personnel development and leadership abilities.
?Other projects and activities as assigned.
Education:Bachelor of Science degree (Advanced degree preferred)
Experience:At least 7-10 years of regulatory affairs and quality assurance management experience in the pharmaceutical and/or biotech industry.
At least 4 years in a senior management role, preferably experience with products and product candidates for the treatment of cancer, autoimmune, and inflammatory diseases or disorders.
Competencies & Skills:
?A thorough understanding of all regulatory and quality requirements applicable to the late-phase product candidates.
?Proven expertise in the drug development process, including experience with IND filing(s) and/or NDA/MAA filing(s).
?A successful track record of effective interaction and communication with FDA and other regulatory authorities in the development and registration of product candidates.
?Proven ability as a strong manager, mentor, and leader with a track record of creating a positive work environment through an emphasis on collaboration, initiative, ownership, accountability, and mutual respect.
?Proven expertise in the drug development process.
?Excellent strategic thinking skills and a willingness to be hands on.
?Ability to work in a fast-paced, entrepreneurial environment with a sense of urgency.
?Ability to operate in a project management driven matrix environment.
?Outstanding written and verbal communication skills with the ability to present effectively to a wide range of audiences.
?Team player with strong leadership and communication skills.
?Energetic, enthusiastic, organized and sufficiently resilient to deal efficiently and diplomatically with conflicting demands.
?Results oriented leader with a naturally questioning, but positive and constructive approach, constantly seeking to improve processes and practices.
?Proven ability to manage and work successfully in a high-growth collaborative environment.
Technical Knowledge:Equipment: PC, scanners, facsimile machine, voice mail and email systems, and other common machines. Must have the ability to be trained on new equipment.
Software Knowledge:Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe.
Environmental Conditions:Physical Activities: While performing the duties of this job, the employee is frequently required to sit at desk for a long period of time; intermittently answer the telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The employee may need to use their hands to finger, handle, or feel objects, tools, or controls, and reach with their arms. The noise level in the work environment is usually low to moderate. The vision abilities required by this job include close vision and the ability to adjust focus.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
||4215 Sorrento Valley Boulevard |
San Diego, CA 92121